SUPERFLAB
FDA 510(k) clearance K812893 · decided 1981-12-08
Clearance details
- K-number
- K812893
- Device name
- SUPERFLAB
- Applicant
- Mick Radio-Nuclear Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-10-15
- Decision date
- 1981-12-08
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- IYP
- Device class
- 1
- Regulation number
- 892.1370
- 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 |
|---|---|---|
| SCANMATE III (K921878) | Circadian, Inc. | 1992-09-11 |
| LINEAR SCANNER PROBE ELSCINT LTD. TL-35 (K844189) | Elscint, Inc. | 1985-02-25 |
Recalls involving this device
No recalls on record reference this clearance.