IMAGING JET SYSTEM
FDA 510(k) clearance K970782 · decided 1997-11-13
Clearance details
- K-number
- K970782
- Device name
- IMAGING JET SYSTEM
- Applicant
- General Robotic Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-03-04
- Decision date
- 1997-11-13
- Days to decision
- 254 days
- Clearance type
- Traditional
- Product code
- JAB
- Device class
- 2
- Regulation number
- 892.1660
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Ypsilanti, MI, 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 |
|---|---|---|
| ZIKON 100 DIGITAL X-RAY SYSTEM (K813032) | Kontron Instruments, Inc. | 1981-11-24 |
Recalls involving this device
No recalls on record reference this clearance.