DIGIRAD REUSABLE IMAGE MEDIA
FDA 510(k) clearance K854407 · decided 1986-03-10
Clearance details
- K-number
- K854407
- Device name
- DIGIRAD REUSABLE IMAGE MEDIA
- Applicant
- Digirad Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-11-01
- Decision date
- 1986-03-10
- Days to decision
- 129 days
- Clearance type
- Traditional
- Product code
- LQA
- Device class
- 1
- Regulation number
- 892.1840
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.