+19 % change
Extra-EU imports of CN 90181200 were up 19% in 2025 compared with 2020 (€862.6 million), calculated from Eurostat values.
Eurostat723.4 EUR million
EU exports of CN 90181200 to countries outside the EU were worth €723.4 million in 2025.
Eurostat838.8 EUR million
Trade between EU member states in CN 90181200 (intra-EU arrivals) came to €838.8 million in 2025.
EurostatSource: Eurostat
Why this market is moving now
- Extra-EU import value moved +19% from 2020 to 2025, a direct read on EU demand for sourced supply.
- Supply is concentrated: one country provided a large share of extra-EU imports in 2025.
- US employment in the core industry shifted -1% since 2020.
What this market covers
Ultrasound scanners that sweep the whole breast with a wide transducer to create three dimensional images. Imaging centres use them as a supplement to mammography, especially for dense breasts.
Typical segments
- Whole breast scanners
- Handheld ultrasound with automation
- Computer aided detection software
- Image archiving tools
Who buys
- Hospitals
- Breast imaging centres
- Diagnostic chains
Largest non-EU suppliers to the EU
| Country | Import value |
|---|---|
| China | 267.5 EUR million |
| United States from 1995 -> 2000) | 227.4 EUR million |
| Korea, Republic of | 222.6 EUR million |
| Japan | 143.9 EUR million |
| Norway | 64.1 EUR million |
| Malaysia | 26.4 EUR million |
Key figures
Each figure links to the page it came from.
| Figure | Value | Year | Source |
|---|---|---|---|
| The EU imported €1.03 billion of products under CN code 90181200 (Ultrasonic scanning apparatus) from outside the EU in 2025. | 1.03 EUR billion | 2025 | Eurostat |
| Extra-EU imports of CN 90181200 were up 19% in 2025 compared with 2020 (€862.6 million), calculated from Eurostat values. | +19 % change | 2025 | Eurostat |
| EU exports of CN 90181200 to countries outside the EU were worth €723.4 million in 2025. | 723.4 EUR million | 2025 | Eurostat |
| Trade between EU member states in CN 90181200 (intra-EU arrivals) came to €838.8 million in 2025. | 838.8 EUR million | 2025 | Eurostat |
| China was the largest non-EU supplier of CN 90181200 to the EU in 2025, with €267.5 million, or 26% of extra-EU imports. | 267.5 EUR million | 2025 | Eurostat |
| EU exports of CN 90181200 to the United States were €158.0 million in 2025. | 158.0 EUR million | 2025 | Eurostat |
| The average value of extra-EU imports of CN 90181200 was €221.10 per kilogram in 2025, calculated from Eurostat value and weight. | 221.10 EUR per kg | 2025 | Eurostat |
| Germany was the largest EU exporter of CN 90181200 to non-EU countries in 2025, at €168.6 million. | 168.6 EUR million | 2025 | Eurostat |
| The EU had 1,791 enterprises in NACE class C2660 (Manufacture of irradiation, electromedical and electrotherapeutic equipment) in 2023. | 1,791 enterprises | 2023 | Eurostat |
| EU enterprises in NACE class C2660 had net turnover of €30.54 billion in 2023. | 30.54 EUR billion | 2023 | Eurostat |
| NACE class C2660 employed 74,126 people across the EU in 2021. | 74,126 persons employed | 2021 | Eurostat |
| The US had 2,220 private establishments in NAICS 334510 (Electromedical and electrotherapeutic apparatus manufacturing) in 2025. | 2,220 establishments | 2025 | U.S. Bureau of Labor Statistics |
| NAICS 334510 employed an average of 72,575 people in US private industry in 2025. | 72,575 jobs | 2025 | U.S. Bureau of Labor Statistics |
| US employment in NAICS 334510 changed by -1% between 2020 (73,147 jobs) and 2025, calculated from BLS figures. | -1 % change | 2025 | U.S. Bureau of Labor Statistics |
| Average annual pay in US NAICS 334510 was $140,429 in 2025. | 140,429 USD per year | 2025 | U.S. Bureau of Labor Statistics |
| The FDA has recorded 4 510(k) clearances for devices named "breast ultrasound". | 4 510(k) clearances | 2026 | U.S. Food and Drug Administration (openFDA) |
| 1 of those clearances were issued from 2021 to 2025. | 1 510(k) clearances | 2025 | U.S. Food and Drug Administration (openFDA) |
| Isono Health, Inc. holds 1 510(k) clearances for devices named "breast ultrasound". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration (openFDA) |
| Sonocine, Inc. holds 1 510(k) clearances for devices named "breast ultrasound". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration (openFDA) |
| U-System, Inc. holds 1 510(k) clearances for devices named "breast ultrasound". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration (openFDA) |
| U-Systems, Inc. holds 1 510(k) clearances for devices named "breast ultrasound". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration (openFDA) |
| PubMed indexed 26 papers mentioning "automated breast ultrasound" in the title or abstract in 2025. | 26 papers | 2025 | U.S. National Library of Medicine (PubMed) |
Companies to watch
Isono Health, Inc.
1 FDA 510(k) clearances for devices named "breast ultrasound".
Sonocine, Inc.
1 FDA 510(k) clearances for devices named "breast ultrasound".
U-System, Inc.
1 FDA 510(k) clearances for devices named "breast ultrasound".
U-Systems, Inc.
1 FDA 510(k) clearances for devices named "breast ultrasound".
What the full report covers
- 1
Executive summary
The answer on two pages: size, growth and what drives it.
- 2
Market size and outlook
History, the current year and a five-year view with base, low and high cases.
- 3
Segments and regions
Splits by product, buyer and geography across the US, Europe and MEA.
- 4
Company profiles
The main players, how they compete and where they are investing.
- 5
Data and method
Every figure in Excel, with the sources and assumptions behind it.
- 01Executive summary
The answer in one page: size, direction and what moves it - 02Market definition and scope
What is in and out of the European Union market - 03Market size, 2021 to 2025
Historical series and growth rates - 04Outlook to 2031
Base, low and high scenarios with stated assumptions - 05Rules, policy and deadlines
Regulation and programmes that change demand - 06Drivers and barriers
What accelerates or slows adoption, by customer segment - 07Prices, costs and margins
Unit economics where public data allows - 08Competitive landscape
8 to 12 company profiles with recent moves - 09Opportunities and risks
For new entrants, suppliers and investors - 10Method and sources
Every assumption and source, listed
Included with the full report
- PDF report, 40 to 60 pages
- Excel data pack
- Ready-to-use charts
- Method note and assumptions
- Written to order in 5 working days
Frequently asked questions
How big is the EU automated breast ultrasound system market?
There is no single official market total. Eurostat trade data shows the EU imported €1.03 billion of goods under CN 90181200 from outside the EU in 2025 and exported €723.4 million.
Where does the EU import automated breast ultrasound system from?
China was the largest non-EU supplier in 2025. The next largest were United States from 1995 -> 2000), Korea, Republic of, Japan.
What is the average import price of automated breast ultrasound system in the EU?
Dividing Eurostat import value by weight gives about €221.10 per kilogram for CN 90181200 in 2025.
Which EU countries export the most automated breast ultrasound system?
Germany led EU exports to non-EU countries in 2025, followed by Austria, Netherlands.
How many automated breast ultrasound system devices are cleared by the FDA?
openFDA lists 4 510(k) clearances for devices named breast ultrasound.
Which companies hold the most FDA clearances for automated breast ultrasound system?
By 510(k) count: Isono Health, Inc., Sonocine, Inc., U-System, Inc., U-Systems, Inc..
Sources and method
The figures on this page come from the public sources listed below. Read how we work.
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
DS-045409, reporter EU27_2020, product 90181200, partner EXT_EU27_2020, flow import, 2025, VALUE_IN_EUROS 1026140792
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
DS-045409, reporter EU27_2020, product 90181200, flow import, 2020 VALUE_IN_EUROS 862608968; 2025 VALUE_IN_EUROS 1026140792
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
DS-045409, reporter EU27_2020, product 90181200, partner EXT_EU27_2020, flow export, 2025, VALUE_IN_EUROS 723423697
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
DS-045409, reporter EU27_2020, product 90181200, partner INT_EU27_2020, flow import, 2025, VALUE_IN_EUROS 838810958
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
DS-045409, reporter EU27_2020, product 90181200, partner CN, flow import, 2025, VALUE_IN_EUROS 267516302
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
DS-045409, reporter EU27_2020, product 90181200, partner US, flow export, 2025, VALUE_IN_EUROS 157991215
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
DS-045409, reporter EU27_2020, product 90181200, flow import, 2025, VALUE_IN_EUROS 1026140792, QUANTITY_IN_100KG 46410
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
DS-045409, reporter DE, product 90181200, partner EXT_EU27_2020, flow export, 2025, VALUE_IN_EUROS 168589924
- Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)
sbs_ovw_act, geo EU27_2020, nace_r2 C2660, indic_sbs ENT_NR, 2023, 1791
- Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)
sbs_ovw_act, geo EU27_2020, nace_r2 C2660, indic_sbs NETTUR_MEUR, 2023, 30540
- Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)
sbs_ovw_act, geo EU27_2020, nace_r2 C2660, indic_sbs EMP_NR, 2021, 74126
- U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 334510, 2025 (2026-11-04)
QCEW 2025 annual, US000, private, NAICS 334510, annual_avg_estabs 2220
- U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 334510, 2025 (2026-11-04)
QCEW 2025 annual, US000, private, NAICS 334510, annual_avg_emplvl 72575
- U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 334510, 2025 (2026-11-04)
QCEW 2020 annual_avg_emplvl 73147; 2025 annual_avg_emplvl 72575
- U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 334510, 2025 (2026-11-04)
QCEW 2025 annual, US000, private, NAICS 334510, avg_annual_pay 140429
- U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances, device_name "breast ultrasound" (2026-11-04)
openFDA device/510k device_name:"breast ultrasound", sum of counts by decision_date = 4
- U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances, device_name "breast ultrasound" (2026-11-04)
openFDA device/510k decision_date 2021-2025 count = 1
- U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "breast ultrasound" (2026-11-04)
applicant.exact "Isono Health, Inc." count 1
- U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "breast ultrasound" (2026-11-04)
applicant.exact "Sonocine, Inc." count 1
- U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "breast ultrasound" (2026-11-04)
applicant.exact "U-System, Inc." count 1
- U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "breast ultrasound" (2026-11-04)
applicant.exact "U-Systems, Inc." count 1
- U.S. National Library of Medicine (PubMed): PubMed search "automated breast ultrasound"[tiab] AND 2025[dp] (2026-11-04)
esearch count 26
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