SCANMATE III
FDA 510(k) clearance K921878 · decided 1992-09-11
Clearance details
- K-number
- K921878
- Device name
- SCANMATE III
- Applicant
- Circadian, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-04-20
- Decision date
- 1992-09-11
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- IYP
- Device class
- 1
- Regulation number
- 892.1370
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- San Leandro, CA, 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 |
|---|---|---|
| LINEAR SCANNER PROBE ELSCINT LTD. TL-35 (K844189) | Elscint, Inc. | 1985-02-25 |
| SUPERFLAB (K812893) | Mick Radio-Nuclear Instruments, Inc. | 1981-12-08 |
Recalls involving this device
No recalls on record reference this clearance.