The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Digicam Lhp (digital Laser High Performance).
| Device ID | K883324 |
| 510k Number | K883324 |
| Device Name: | DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE) |
| Classification | Camera, Multi Format, Radiological |
| Applicant | SIEMENS GAMMASONICS, INC. 2000 NUCLEAR DR. Des Plaines, IL 60018 |
| Contact | Marribeth Adams |
| Correspondent | Marribeth Adams SIEMENS GAMMASONICS, INC. 2000 NUCLEAR DR. Des Plaines, IL 60018 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-05 |
| Decision Date | 1989-02-27 |