KQA
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Device, Beam Limiting, X-Ray, Therapeutic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.5900
- Medical specialty
- Radiology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PAPILLION PROCTOSCOPE (K914784) | Oldelft Corp. of America | 1992-06-05 |
| PHILIPS RT250 COLLIMATOR (PK8050) (K885126) | Perkins Mfg. Co. | 1989-06-01 |
| THE MCP-70-SE SYSTEM (K844180) | Ellis Pharmaceutical Consulting, Inc. | 1985-02-01 |
| COLLIMATOR, BILATERIAL (K790168) | Cmsi | 1979-02-15 |
Track KQA automatically
Every clearance here is in the API, with alerts when new ones post.