CLEON IMAGER
FDA 510(k) clearance K770530 · decided 1977-04-05
Clearance details
- K-number
- K770530
- Device name
- CLEON IMAGER
- Applicant
- Union Carbide Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-03-21
- Decision date
- 1977-04-05
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- JAM
- Device class
- 1
- Regulation number
- 892.1330
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| WBA - I.R.I.S. (K842895) | Siemens Gammasonics, Inc. | 1984-08-27 |
| MAXICAMERA 400T W/BODY CONTOUR TOMOGRA (K841996) | General Electric Co. | 1984-07-16 |
Recalls involving this device
No recalls on record reference this clearance.