The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Digitron Stenosis Protocol.
| Device ID | K881481 |
| 510k Number | K881481 |
| Device Name: | DIGITRON STENOSIS PROTOCOL |
| Classification | System, Image Processing, Radiological |
| 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 | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-08 |
| Decision Date | 1988-10-12 |