510(k) Report

FDA applicant

Precision Therapy Intl., Inc.

Norcross, GA4 decisions1995–20024 recalls

FDA records 4 decisions for Precision Therapy Intl., Inc. (Norcross, GA) from 1995 to 2002: 4 510(k) clearances. Most are in product codes MUJ (System, Planning, Radiation Therapy Treatment) and IYE (Accelerator, Linear, Medical). Its devices cite 2 predicates, 1 of them its own earlier devices. 4 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 Precision Therapy Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Precision Therapy Intl., Inc. since 2007.

Recalls per year

3in 2008

2008: 3
2007high 3 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • MUJSystem, Planning, Radiation Therapy Treatment3decisions
  • IYEAccelerator, Linear, Medical1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K950061Hercules Radiation Therapy CouchPrecision Therapy Intl., Inc. · 19952cite it
  • K002240Render-Plan 3-D 4.00 & Precise-Plan 1.0Precision Therapy Intl., Inc. · 20001cites it

What has FDA decided for it lately?

  • K022411Preciseplan 2.0Precision Therapy Intl., Inc. · 20024 recalls
  • K002240Render-Plan 3-D 4.00 & Precise-Plan 1.0Precision Therapy Intl., Inc. · 2000
  • K992864Render-Plan 3-DPrecision Therapy Intl., Inc. · 1999
  • K950061Hercules Radiation Therapy CouchPrecision Therapy Intl., Inc. · 1995

All 4 as Precision Therapy Intl., Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K022411PrecisePLAN 2.15 Treatment Planning System. The product is used to plan multiple beam…Sep 30, 2008
  • K022411PrecisePLAN Treatment Planning System Intended use: To plan multiple beam radiation…Feb 5, 2008
  • K022411PrecisePLAN Treatment Planning System To plan multiple beam radiation therapy treatments.Jan 28, 2008
  • K022411PrecisePLAN 2.10 Treatment Planning SystemMar 15, 2006