The following data is part of a premarket notification filed by Digirad Corp. with the FDA for Ergo Imaging System.
| Device ID | K123408 |
| 510k Number | K123408 |
| Device Name: | ERGO IMAGING SYSTEM |
| Classification | Camera, Scintillation (gamma) |
| Applicant | DIGIRAD CORP. 13950 STOWE DRIVE Poway, CA 92064 -8803 |
| Contact | Matthew Olow |
| Correspondent | Matthew Olow DIGIRAD CORP. 13950 STOWE DRIVE Poway, CA 92064 -8803 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-05 |
| Decision Date | 2013-01-15 |
| Summary: | summary |