Healthcare ranking
Top 10 US radiology and imaging device companies by FDA clearances 2026
GE HealthCare received the most FDA 510(k) clearances for radiology and imaging devices of any company headquartered in the United States between 1 November 2025 and 31 October 2026, with 27 clearances. The list ranks US companies by the number of clearances assigned to the radiology review panel in that period.
Top 10 at a glance
The full list
| Rank | Company | FDA 510(k) clearances (clearances) |
|---|---|---|
| 1 | GE HealthCare | 27 |
| 2 | Radformation | 6 |
| 3 | Boston Scientific | 4 |
| 3 | Dentsply Sirona | 4 |
| 3 | Rivanna Medical | 4 |
| 6 | Ischemaview | 3 |
| 6 | Mighty Oak Medical | 3 |
| 6 | Neurocareai | 3 |
| 6 | Overjet | 3 |
| 10 | A2z Radiology Ai | 2 |
| 10 | BunkerHill Health | 2 |
| 10 | Carestream Health | 2 |
| 10 | Cleerly | 2 |
| 10 | DeepHealth | 2 |
| 10 | Hyperfine | 2 |
| 10 | Mim Software | 2 |
| 10 | Stabilix | 2 |
| 10 | Subtle Medical | 2 |
| 10 | Velmeni | 2 |
How this list is built
We counted FDA 510(k) clearances (substantially equivalent decisions) with a decision date from 1 November 2025 to 31 October 2026 assigned to the radiology review panel; De Novo grants are not counted. Clearances held by subsidiaries and under name variants are merged into the parent company ("GE Medical Systems Ultrasound and Primary Care Diagnostics" and "GE Healthcare" are counted as GE HealthCare), and government bodies, hospitals and universities are left out. Each company is placed in the country of its headquarters, or of its parent company after merging, so a US subsidiary of a German group counts for Germany. Companies with the same count share a rank, and all companies tied at the last place are shown.
Every position is set by the data alone, by the same rules for every company. Spotted something to update? Write to info@stratummarketresearch.com with the list and the line, and we correct it within two working days.
For ranked companies: a free badge
Ranked companies can show this badge on their website, in a press release or on LinkedIn at no cost. Pick your company, then copy the code.
Frequently asked questions
Who is number one in the US radiology and imaging device companies by FDA clearances ranking?
GE HealthCare ranks first with 27 clearances (1 November 2025 to 31 October 2026).
How is this ranking calculated?
We counted FDA 510(k) clearances (substantially equivalent decisions) with a decision date from 1 November 2025 to 31 October 2026 assigned to the radiology review panel; De Novo grants are not counted. Clearances held by subsidiaries and under name variants are merged into the parent company ("GE Medical Systems Ultrasound and Primary Care Diagnostics" and "GE Healthcare" are counted as GE HealthCare), and government bodies, hospitals and universities are left out. Each company is placed in the country of its headquarters, or of its parent company after merging, so a US subsidiary of a German group counts for Germany. Companies with the same count share a rank, and all companies tied at the last place are shown.
Can a company pay to rank higher?
Positions come only from the counts described above, and inclusion is free. Every company is ranked by the same rules.
How often is the ranking updated?
Every list is recomputed each quarter from the latest public records, and the update date is printed on the page.
Can a ranked company use the badge?
Yes. Every ranked company can use the free web badge on this page on its website, in press releases and on social media.
Custom research
Looking for a specific market?
Tell us the market, the region and the decision you are making. We reply within one working day with a scope and a date.