510(k) Report

FDA applicant

Medical Physics Instrumentation, Inc.

Bartlett, TN1 decision1995–19952 recalls

FDA records 1 decision for Medical Physics Instrumentation, Inc. (Bartlett, TN) in 1995: 1 510(k) clearance. All are in product code IYE (Accelerator, Linear, Medical). 2 recalls are 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 Medical Physics Instrumentation, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Physics Instrumentation, Inc. since 2007.

Recalls per year

1in 2017

2015: 12017: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medical Physics Instrumentation, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medical Physics Instrumentation, 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

Which product codes does it file in?

  • IYEAccelerator, Linear, Medical1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K945321Wellhofer WP700 V. 3.2Medical Physics Instrumentation, Inc. · 19952cite it

What has FDA decided for it lately?

  • K945321Wellhofer WP700 V. 3.2Medical Physics Instrumentation, Inc. · 19952 recalls

The one decision as Medical Physics Instrumentation, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K945321Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T…Apr 26, 2017Class II
  • K945321IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2Dec 10, 2015Class II