The following data is part of a premarket notification filed by Digital Design, Inc. with the FDA for D2 Spectrum Gamma Camera/crystal V Computer System.
| Device ID | K904599 |
| 510k Number | K904599 |
| Device Name: | D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM |
| Classification | System, Tomographic, Nuclear |
| Applicant | DIGITAL DESIGN, INC. 3060 E. BUSINESS PARK DR. Norcross, GA 30071 |
| Contact | Thomas Bergquist |
| Correspondent | Thomas Bergquist DIGITAL DESIGN, INC. 3060 E. BUSINESS PARK DR. Norcross, GA 30071 |
| Product Code | JWM |
| CFR Regulation Number | 892.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-10 |
| Decision Date | 1991-04-23 |