The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Basicam S Counter Balance Camera.
| Device ID | K860454 |
| 510k Number | K860454 |
| Device Name: | BASICAM S COUNTER BALANCE CAMERA |
| Classification | Holder, Radiographic Cassette, Wall-mounted |
| Applicant | SIEMENS GAMMASONICS, INC. 2000 NUCLEAR DR. Des Plaines, IL 60018 |
| Contact | Joseph P Stowell |
| Correspondent | Joseph P Stowell SIEMENS GAMMASONICS, INC. 2000 NUCLEAR DR. Des Plaines, IL 60018 |
| Product Code | IXY |
| CFR Regulation Number | 892.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-05 |
| Decision Date | 1986-02-21 |