The following data is part of a premarket notification filed by Prism Clinical Imaging, Inc. with the FDA for Prism Acquire (version 1.5), Prism Process (version 1.5), Prism View (version 2.5).
| Device ID | K082964 |
| 510k Number | K082964 |
| Device Name: | PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5) |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PRISM CLINICAL IMAGING, INC. 851 S. 70TH ST., SUITE 103 West Allis, WI 53214 |
| Contact | James L Reuss |
| Correspondent | James L Reuss PRISM CLINICAL IMAGING, INC. 851 S. 70TH ST., SUITE 103 West Allis, WI 53214 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-03 |
| Decision Date | 2009-03-09 |
| Summary: | summary |