The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Digitron 2, Digital Substraction Angio. System.
| Device ID | K883072 |
| 510k Number | K883072 |
| Device Name: | DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM |
| Classification | System, X-ray, Angiographic |
| Applicant | SIEMENS GAMMASONICS, INC. 2000 NUCLEAR DR. Des Plaines, IL 60018 |
| Contact | Merribeth Adams |
| Correspondent | Merribeth Adams SIEMENS GAMMASONICS, INC. 2000 NUCLEAR DR. Des Plaines, IL 60018 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-20 |
| Decision Date | 1988-09-14 |