FDA applicant

Prism Clinical Imaging, Inc.

West Allis, WI2 decisions2009–20120 recalls

FDA records 2 decisions for Prism Clinical Imaging, Inc. (West Allis, WI) from 2009 to 2012: 2 510(k) clearances. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 6 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Prism Clinical Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Prism Clinical Imaging, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Prism Clinical Imaging, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Prism”

FDA records each applicant name separately; these may or may not be the same firm.

Prism Technologies, Inc. 5 Prism Imaging, Inc. 4 Prism Enterprises, Inc. 4 Prism Therapeutics, LLC 1 Prism Surgical Design Pty, Ltd. 1 Prism Surgical Designs Pty, Ltd. 1

Prism Clinical Imaging, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Prism”