The following data is part of a premarket notification filed by Digi Rad Corp. with the FDA for Digirad System 1 And The Reusuable Image Media.
| Device ID | K852284 |
| 510k Number | K852284 |
| Device Name: | DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA |
| Classification | System, Image Processing, Radiological |
| Applicant | DIGI RAD CORP. 1047 ELWELL COURT Palo Alto, CA 94303 |
| Contact | Ramesh C Trivedi |
| Correspondent | Ramesh C Trivedi DIGI RAD CORP. 1047 ELWELL COURT Palo Alto, CA 94303 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-29 |
| Decision Date | 1985-11-14 |