The following data is part of a premarket notification filed by Prism Clinical Imaging, Inc. with the FDA for Prism Acquire Prism Process Prism View.
| Device ID | K122026 |
| 510k Number | K122026 |
| Device Name: | PRISM ACQUIRE PRISM PROCESS PRISM VIEW |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PRISM CLINICAL IMAGING, INC. 890 Elm Grove Rd., Suite 215 Elm Grove, WI 53122 |
| Contact | James L Reuss |
| Correspondent | James L Reuss PRISM CLINICAL IMAGING, INC. 890 Elm Grove Rd., Suite 215 Elm Grove, WI 53122 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-11 |
| Decision Date | 2012-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B358PCI01PV410 | K122026 | 000 |
| B358PCI01PV0 | K122026 | 000 |
| B358PCI01PP0 | K122026 | 000 |
| B358PCI01PA0 | K122026 | 000 |