KQAClass II
Device, Beam Limiting, X-Ray, Therapeutic
21 CFR 892.5900 / Radiology
KQA is the FDA product code for Device, Beam Limiting, X-Ray, Therapeutic, a class II device type, regulated under 21 CFR 892.5900. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- KQA
- Device name
- Device, Beam Limiting, X-Ray, Therapeutic
- Regulation
- 21 CFR 892.5900
- Device class
- Class II
- Review panel
- Radiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 4
- Ingested recalls
- 0
Clearances, product code KQA
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1985 | 1 |
| 1989 | 1 |
| 1992 | 1 |
Applicants with the most clearances
Product code KQA| Applicant | Clearances |
|---|---|
| Cmsi | 1 |
| Ellis Pharmaceutical Consulting, Inc. | 1 |
| Oldelft Corp. of America | 1 |
| Perkins Mfg. Co. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code KQA.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.