510(k) Report

FDA applicant

Ptw-New York Corp.

Bellmore, NY8 decisions1995–20061 recall

FDA records 8 decisions for Ptw-New York Corp. (Bellmore, NY) from 1995 to 2006: 8 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and LHN (System, Radiation Therapy, Charged-Particle…). Its devices cite 6 predicates, 4 of them its own earlier devices. 1 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 Ptw-New York Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ptw-New York Corp. since 2007.

Recalls per year

1in 2015

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

Class I Class II/III not classified

FIG. 1 — Ptw-New York Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ptw-New York Corp.’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
  • LHNSystem, Radiation Therapy, Charged-Particle, Medical2decisions
  • KXKSource, Brachytherapy, Radionuclide1decision

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 10 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.

  • K954165PTW-MP3 & PTW-MP3S Automatic Water PhantomPtw-New York Corp. · 19954cite it
  • K062817PTW David Imrt QC Verification SystemPtw-New York Corp. · 20063cite it
  • K951764Unidos Universal Dosimeter Model 10002-with TNC Connector, 10005-with BNT ConnectorPtw-New York Corp. · 19951cites it
  • K9722120.015CC Pinpoint Ionization Chamber, 0.005 CC Pinpoint Ionization ChamberPtw-New York Corp. · 19971cites it
  • K972211Multidos, QC6PLUSPtw-New York Corp. · 19971cites it

What has FDA decided for it lately?

  • K062817PTW David Imrt QC Verification SystemPtw-New York Corp. · 2006
  • K010705OptidosPtw-New York Corp. · 2003
  • K010916PTW Dosimetry Diode, T60008Ptw-New York Corp. · 2001
  • K9722120.015CC Pinpoint Ionization Chamber, 0.005 CC Pinpoint Ionization ChamberPtw-New York Corp. · 1997
  • K972211Multidos, QC6PLUSPtw-New York Corp. · 1997
  • K9612080.6CC Ionization Chamber - Waterproof 0.6CC Ionization ChamberPtw-New York Corp. · 1996
  • K954165PTW-MP3 & PTW-MP3S Automatic Water PhantomPtw-New York Corp. · 1995
  • K951764Unidos Universal Dosimeter Model 10002-with TNC Connector, 10005-with BNT ConnectorPtw-New York Corp. · 19951 recall

All 8 as Ptw-New York Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K951764PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version…May 27, 2015Class II