510(k) K854407
- Device
- DIGIRAD REUSABLE IMAGE MEDIA
- Applicant
- DIGI RAD CORP.
- 510(k) number
- K854407
- Product code
- LQA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-03-10
- Date received
- 1985-11-01
- Regulation
- 892.1840
- Classification name
- Media, Reusable Image
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CLAIRE ANDREWS-EURGL
- Address
- 1047 Elwell Ct. Palo Alto CA US 94303 94303
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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