510(k) Report

FDA applicant

Integrity Medical Software, Inc.

Tyler, TX1 decision1999–19990 recalls

FDA records 1 decision for Integrity Medical Software, Inc. (Tyler, TX) in 1999: 1 510(k) clearance. All are in product code IYE (Accelerator, Linear, Medical). Its devices cite 1 predicate, 0 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 Integrity Medical Software, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Integrity Medical Software, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • IYEAccelerator, Linear, Medical1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K990833Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 19991cites it

What has FDA decided for it lately?

  • K990833Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999

The one decision as Integrity Medical Software, Inc. →

Other applicant names beginning “Integrity”

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

Integrity Implants, Inc. 11Integrity Spine 2Integrity Optics, Inc. 2Integrity Practice Management, Inc. 1Integrity Life Sciences 1Integrity Spine Lumbar Interbody Fusion System 1Integrity Implants Inc. Dba Accelus 1Integrity Orthopaedics, Inc. 1