CRS RADIATION BEAM SCANNER
FDA 510(k) clearance K914821 · decided 1992-12-17
Clearance details
- K-number
- K914821
- Device name
- CRS RADIATION BEAM SCANNER
- Applicant
- Consolidated Radiation Services, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-10-25
- Decision date
- 1992-12-17
- Days to decision
- 419 days
- Clearance type
- Traditional
- Product code
- IYI
- Device class
- 2
- Regulation number
- 892.5900
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Vero Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 37-702 AND 37-703 PC RAINBOW (K900932) | Victoreen, Inc. | 1990-12-05 |
Recalls involving this device
No recalls on record reference this clearance.