510(k) Report

FDA applicant

Victoreen, Inc.

Carle Place, NY40 decisions1979–19980 recalls

FDA records 40 decisions for Victoreen, Inc. (Carle Place, NY) from 1979 to 1998: 40 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and KPR (System, X-Ray, Stationary). Its devices cite 6 predicates, 4 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 Victoreen, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Victoreen, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Victoreen, 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?

  • IYEAccelerator, Linear, Medical5decisions
  • KPRSystem, X-Ray, Stationary4decisions
  • LHOInstrument, Quality-Assurance, Radiologic3decisions
  • EAKScreen, Leaded, Operator Radiation Protector3decisions
  • KPQSystem, Simulation, Radiation Therapy3decisions
  • KPTCalibrator, Dose, Radionuclide2decisions

Also: LHN (2), IXY (1), IYI (1), KPX (1), JAQ (1), IXF (1).

Whose devices does it build on?

Its devices cite 6 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 4 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.

  • K90093237-702 and 37-703 PC RainbowVictoreen, Inc. · 19901cites it
  • K971382Prone Breast Positioning Board, Model #37-018Victoreen, Inc. · 19971cites it
  • K940660Model 37-720 Dual Diode Dosimetry SystemVictoreen, Inc. · 19941cites it
  • K931927Victoreen Model 530Victoreen, Inc. · 19931cites it
  • K853753Diamentor Patient X-Ray Exposure Indicator 07302Victoreen, Inc. · 19851cites it
  • K932342Model 500-6 Radiation Therapy Ionization ChamberVictoreen, Inc. · 19931cites it

What has FDA decided for it lately?

  • K982937Model 580-006 Radiation Therapy Ionization ChamberVictoreen, Inc. · 1998
  • K974112Vacudap, Model 2000, 2001Victoreen, Inc. · 1998
  • K973960MODEL 37-185Victoreen, Inc. · 1998
  • K964952Veridose V (Five), Model Number 37-705Victoreen, Inc. · 1997
  • K964785Veridose DiodesVictoreen, Inc. · 1997
  • K971382Prone Breast Positioning Board, Model #37-018Victoreen, Inc. · 1997
  • K952233Clear-PB Lead Plastic Overhead Barrier 56-628Victoreen, Inc. · 1995
  • K940660Model 37-720 Dual Diode Dosimetry SystemVictoreen, Inc. · 1994

All 40 as Victoreen, Inc. →