The following data is part of a premarket notification filed by Quantum Medical Imaging, Llc. with the FDA for Quantum Direx System.
| Device ID | K072010 |
| 510k Number | K072010 |
| Device Name: | QUANTUM DIREX SYSTEM |
| Classification | System, X-ray, Stationary |
| Applicant | QUANTUM MEDICAL IMAGING, LLC. 2002-B ORVILLE DRIVE NORTH Ronkonkoma, NY 11779 -7661 |
| Contact | Mark Camirand |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-07-23 |
| Decision Date | 2007-08-07 |
| Summary: | summary |