K828562Substantially Equivalent
Digirad CFR 2000 Radiographic Film Cassette
Digirad Corp., Palo Alto CA / Traditional, Substantially Equivalent
K828562 is the FDA 510(k) clearance record for DIGIRAD CFR 2000 RADIOGRAPHIC FILM CASSETTE, cleared for Digirad Corp. on . FDA records list 16 510(k) clearances for Digirad Corp., from to . As of , FDA records show no recalls naming K828562.
Clearance record
- Decision date
- Received
- (163 days to decision)
- Review panel
- Unknown
- Applicant
- Digirad Corp. 1047 Elwell Ct., Palo Alto CA
- Third party review
- No
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.