The following data is part of a premarket notification filed by Quantum Medical Imaging, Llc. with the FDA for Quantum/ Canon Cxdi Integration System, Model Qg-dig-cxdi.
| Device ID | K080905 |
| 510k Number | K080905 |
| Device Name: | QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI |
| Classification | System, Image Processing, Radiological |
| Applicant | QUANTUM MEDICAL IMAGING, LLC. 5 WHITCOMB AVENUE Ayer, MA 01432 -7661 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau QUANTUM MEDICAL IMAGING, LLC. 5 WHITCOMB AVENUE Ayer, MA 01432 -7661 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-01 |
| Decision Date | 2008-07-16 |
| Summary: | summary |