United States was the largest outside supplier.
What this market covers
Equipment that images breast tissue to find and assess disease, including mammography, ultrasound and MRI. Hospitals and imaging centres buy it.
Typical segments
- Digital mammography
- Breast tomosynthesis
- Breast ultrasound
- Breast MRI
Source: Eurostat
Why this market is moving now
- Extra-EU import value rose 29% 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.
Key figures
Each figure names the source it came from. Open the source list below to read the quoted line.
| Figure | Value | Year | Source |
|---|---|---|---|
| The EU imported €579.6 million of products under CN code 90221400 (Apparatus based on the use of X-rays, for medical, surgical or veterinary uses) from outside the EU in 2025. | 579.6 EUR million | 2025 | Eurostat |
| Extra-EU imports of CN 90221400 were up 29% in 2025 compared with 2020 (€448.4 million), calculated from Eurostat values. | +29 % since 2020 | 2025 | Eurostat |
| EU exports of CN 90221400 to countries outside the EU were worth €2.62 billion in 2025. | 2.62 EUR billion | 2025 | Eurostat |
| Trade between EU member states in CN 90221400 (intra-EU arrivals) came to €817.0 million in 2025. | 817.0 EUR million | 2025 | Eurostat |
| United States was the largest non-EU supplier of CN 90221400 to the EU in 2025, with €210.8 million, or 36% of extra-EU imports. | 210.8 EUR million | 2025 | Eurostat |
| EU exports of CN 90221400 to the United States were €964.9 million in 2025. | 964.9 EUR million | 2025 | Eurostat |
| The average value of extra-EU imports of CN 90221400 was €99.96 per kilogram in 2025, calculated from Eurostat value and weight. | 99.96 EUR per kg | 2025 | Eurostat |
| Netherlands was the largest EU exporter of CN 90221400 to non-EU countries in 2025, at €1.15 billion. | 1.15 EUR billion | 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 298 private establishments in NAICS 334517 (Irradiation apparatus manufacturing) in 2025. | 298 establishments | 2025 | U.S. Bureau of Labor Statistics |
| NAICS 334517 employed an average of 12,771 people in US private industry in 2025. | 12,771 jobs | 2025 | U.S. Bureau of Labor Statistics |
| US employment in NAICS 334517 changed by -9% between 2020 (13,969 jobs) and 2025, calculated from BLS figures. | -9 % since 2020 | 2025 | U.S. Bureau of Labor Statistics |
| Average annual pay in US NAICS 334517 was $135,443 in 2025. | 135,443 USD per year | 2025 | U.S. Bureau of Labor Statistics |
| The FDA has recorded 19 510(k) clearances for devices named "mammography system". | 19 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Elscint, Inc. holds 3 510(k) clearances for devices named "mammography system". | 3 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Bennett X-Ray Corp. holds 2 510(k) clearances for devices named "mammography system". | 2 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Hologic, Inc. holds 2 510(k) clearances for devices named "mammography system". | 2 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Lorad, A Hologic Co. holds 2 510(k) clearances for devices named "mammography system". | 2 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Trex Medical Corp. holds 2 510(k) clearances for devices named "mammography system". | 2 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Agfa Healthcare N.V. holds 1 510(k) clearances for devices named "mammography system". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| PubMed indexed 536 papers mentioning "breast imaging" in the title or abstract in 2025. | 536 papers | 2025 | U.S. National Library of Medicine |
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)
Quoted lines
- Figure 1
DS-045409, reporter EU27_2020, product 90221400, partner EXT_EU27_2020, flow import, 2025, VALUE_IN_EUROS 579627634
- Figure 2
DS-045409, reporter EU27_2020, product 90221400, flow import, 2020 VALUE_IN_EUROS 448387052; 2025 VALUE_IN_EUROS 579627634
- Figure 3
DS-045409, reporter EU27_2020, product 90221400, partner EXT_EU27_2020, flow export, 2025, VALUE_IN_EUROS 2619314354
- Figure 4
DS-045409, reporter EU27_2020, product 90221400, partner INT_EU27_2020, flow import, 2025, VALUE_IN_EUROS 816982865
- Figure 5
DS-045409, reporter EU27_2020, product 90221400, partner US, flow import, 2025, VALUE_IN_EUROS 210753868
- Figure 6
DS-045409, reporter EU27_2020, product 90221400, partner US, flow export, 2025, VALUE_IN_EUROS 964882441
- Figure 7
DS-045409, reporter EU27_2020, product 90221400, flow import, 2025, VALUE_IN_EUROS 579627634, QUANTITY_IN_100KG 57983
- Figure 1
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
Quoted lines
- Figure 8
DS-045409, reporter NL, product 90221400, partner EXT_EU27_2020, flow export, 2025, VALUE_IN_EUROS 1152153207
- Figure 8
- Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)
Quoted lines
- Figure 9
sbs_ovw_act, geo EU27_2020, nace_r2 C2660, indic_sbs ENT_NR, 2023, 1791
- Figure 10
sbs_ovw_act, geo EU27_2020, nace_r2 C2660, indic_sbs NETTUR_MEUR, 2023, 30540
- Figure 11
sbs_ovw_act, geo EU27_2020, nace_r2 C2660, indic_sbs EMP_NR, 2021, 74126
- Figure 9
- U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 334517, 2025 (2026-11-04)
Quoted lines
- Figure 12
QCEW 2025 annual, US000, private, NAICS 334517, annual_avg_estabs 298
- Figure 13
QCEW 2025 annual, US000, private, NAICS 334517, annual_avg_emplvl 12771
- Figure 14
QCEW 2020 annual_avg_emplvl 13969; 2025 annual_avg_emplvl 12771
- Figure 15
QCEW 2025 annual, US000, private, NAICS 334517, avg_annual_pay 135443
- Figure 12
- U.S. Food and Drug Administration: openFDA 510(k) clearances, device_name "mammography system" (2026-11-04)
Quoted lines
- Figure 16
openFDA device/510k device_name:"mammography system", sum of counts by decision_date = 19
- Figure 16
- U.S. Food and Drug Administration: openFDA 510(k) clearances by applicant, device_name "mammography system" (2026-11-04)
Quoted lines
- Figure 17
applicant.exact "Elscint, Inc." count 3
- Figure 18
applicant.exact "Bennett X-Ray Corp." count 2
- Figure 19
applicant.exact "Hologic, Inc." count 2
- Figure 20
applicant.exact "Lorad, A Hologic Co." count 2
- Figure 21
applicant.exact "Trex Medical Corp." count 2
- Figure 22
applicant.exact "Agfa Healthcare N.V." count 1
- Figure 17
- U.S. National Library of Medicine: PubMed search "breast imaging"[tiab] AND 2025[dp] (2026-11-04)
Quoted lines
- Figure 23
esearch count 536
- Figure 23
Buyers and suppliers
Who buys
- Hospitals
- Imaging centres
- Screening programmes
Large non-EU suppliers to the EU
Companies to watch
Elscint, Inc.
3 FDA 510(k) clearances for devices named "mammography system".
Bennett X-Ray Corp.
2 FDA 510(k) clearances for devices named "mammography system".
Hologic, Inc.
2 FDA 510(k) clearances for devices named "mammography system".
Lorad, A Hologic Co.
2 FDA 510(k) clearances for devices named "mammography system".
Trex Medical Corp.
2 FDA 510(k) clearances for devices named "mammography system".
Agfa Healthcare N.V.
1 FDA 510(k) clearances for devices named "mammography system".
What the full report covers
- 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
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- Method note and assumptions
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Frequently asked questions
How big is the EU breast imaging market?
There is no single official market total. Eurostat trade data shows the EU imported €579.6 million of goods under CN 90221400 from outside the EU in 2025 and exported €2.62 billion.
Where does the EU import breast imaging from?
United States was the largest non-EU supplier in 2025. Other large suppliers included United Kingdom, China, Countries and territories not specified within the framework of intra-Union trade.
What is the average import price of breast imaging in the EU?
Dividing Eurostat import value by weight gives about €99.96 per kilogram for CN 90221400 in 2025.
Which EU countries export the most breast imaging?
Netherlands led EU exports to non-EU countries in 2025, followed by Germany, France.
How many breast imaging devices are cleared by the FDA?
openFDA lists 19 510(k) clearances for devices named mammography system.
Which companies hold the most FDA clearances for breast imaging?
By 510(k) count: Elscint, Inc., Bennett X-Ray Corp., Hologic, Inc., Lorad, A Hologic Co..
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