The trailing-24-month QIH leaderboard
| Rank | Sponsor | QIH 510(k)s (24mo) |
|---|---|---|
| 1 | Dia Imaging Analysis | 5 |
| 2 | Overjet | 4 |
| 2 | Peek Health | 4 |
| 2 | Siemens Medical Solutions USA | 4 |
| 5 | Clarius Mobile Health | 3 |
| 5 | Disior | 3 |
| 5 | EOS Imaging | 3 |
| 5 | IschemaView | 3 |
| 5 | United Imaging Healthcare (Shanghai) | 3 |
| 5 | Siemens Healthcare GmbH | 3 |
| Top-10 subtotal | 35 (21% of 168) | |
| Long tail | (≥1 clearance each) | 133 |
Three commercial reads
| Read | Implication |
|---|---|
| Top-10 owns just 21% of the cohort | This is a winners-multiple market, not winner-takes-all |
| No US-based pure-play has >5 clearances | The consolidation play is open |
| Long tail = 133 sponsors with ≥1 clearance | The acquirer-side BD universe is wide; not a 2–3 horse race |
Section 524B context
Every one of these 168 submissions had to clear FDA's Section 524B cybersecurity requirements (Consolidated Appropriations Act 2023): SBOM + secure-development lifecycle as Refuse-to-Accept gates. Any acquirer integrating a QIH portfolio will inherit those compliance obligations.
Verifiable directly on the FDA 510(k) public database — search by product code QIH and date range.
Editorial commentary on publicly available regulatory and public-database data. Not investment, legal, regulatory, or medical advice.