The following data is part of a premarket notification filed by Digi Rad Corp. with the FDA for Digirad Reusable Image Media.
| Device ID | K854407 |
| 510k Number | K854407 |
| Device Name: | DIGIRAD REUSABLE IMAGE MEDIA |
| Classification | Media, Reusable Image |
| Applicant | DIGI RAD CORP. 1047 ELWELL COURT Palo Alto, CA 94303 |
| Contact | Claire Andrews-eurgl |
| Correspondent | Claire Andrews-eurgl DIGI RAD CORP. 1047 ELWELL COURT Palo Alto, CA 94303 |
| Product Code | LQA |
| CFR Regulation Number | 892.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-01 |
| Decision Date | 1986-03-10 |