Data / Medical devices / United States / Prism Clinical Imaging, Inc.
Prism Clinical Imaging, Inc.: FDA-registered device maker in Elm Grove, WI, United States, 1 510(k) clearance
Prism Clinical Imaging, Inc. is registered with the FDA (registration 3005517190) in Elm Grove, WI, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 21, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005517190
- Address
- 890 Elm Grove Rd., Suite 209, Elm Grove, WI, United States, 53122
- Owner or operator
- Prism Clinical Imaging, Inc. (9077251)
- Roles
- Manufacturer
- First device listed
- November 20, 2007
- Registered through
- 2026
- Brand names listed
- Prism Acquire, Prism Connect, Prism Flow, Prism Process, Prism Serve, Prism View
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 21, 2012 | K122026 | PRISM ACQUIRE PRISM PROCESS PRISM VIEW | LNH | Substantially Equivalent | Prism Clinical Imaging, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Digital Image Communications, Radiological
- All makers of System, Image Processing, Radiological
- All makers of System, Nuclear Magnetic Resonance Imaging
Updated September 21, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.