The following data is part of a premarket notification filed by Quantum Medical Imaging, Llc. with the FDA for Universal System, Model Qv-800.
| Device ID | K023008 |
| 510k Number | K023008 |
| Device Name: | UNIVERSAL SYSTEM, MODEL QV-800 |
| Classification | System, X-ray, Stationary |
| Applicant | QUANTUM MEDICAL IMAGING, LLC. 2905 VETERANS MEMORIAL HIGHWAY Ronkonkoma, NY 11779 |
| Contact | Mark Camirand |
| Correspondent | Mark Camirand QUANTUM MEDICAL IMAGING, LLC. 2905 VETERANS MEMORIAL HIGHWAY Ronkonkoma, NY 11779 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-09 |
| Decision Date | 2002-11-13 |
| Summary: | summary |