510(k) Report

FDA applicant

Aktina Medical Physics Corp.

Congers, NY13 decisions1997–20110 recalls

FDA records 13 decisions for Aktina Medical Physics Corp. (Congers, NY) from 1997 to 2011: 13 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and IXI (Block, Beam-Shaping, Radiation Therapy). Its devices cite 20 predicates, 2 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 Aktina Medical Physics Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2008: 12011: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Aktina Medical Physics 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, Medical10decisions
  • IXIBlock, Beam-Shaping, Radiation Therapy2decisions
  • JAICouch, Radiation Therapy, Powered1decision

Whose devices does it build on?

Its devices cite 20 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 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.

  • K003330Aktina Medical Physics Corporation Active Breathing Coordinator (Abc)Aktina Medical Physics Corp. · 20013cite it
  • K991546Aktina Medical Physics Corporation Tilt BoardAktina Medical Physics Corp. · 19991cites it
  • K081935Stereotactic Head and Neck Localizer, Model 50-100Aktina Medical Physics Corp. · 20081cites it

What has FDA decided for it lately?

  • K103616Pinpoint Stereotactic Head and Neck LocalizerAktina Medical Physics Corp. · 2011
  • K081935Stereotactic Head and Neck Localizer, Model 50-100Aktina Medical Physics Corp. · 2008
  • K040709Protos SoftwareAktina Medical Physics Corp. · 2004
  • K032248Precise Carbon Fiber Table Top, Model 11-999Aktina Medical Physics Corp. · 2003
  • K014081Aktina Medical Physics Radiation Therapy WedgesAktina Medical Physics Corp. · 2002
  • K003330Aktina Medical Physics Corporation Active Breathing Coordinator (Abc)Aktina Medical Physics Corp. · 2001
  • K993522Aktina Medical Physics Corporation Tennis Racquet InsertAktina Medical Physics Corp. · 2000
  • K991546Aktina Medical Physics Corporation Tilt BoardAktina Medical Physics Corp. · 1999

All 13 as Aktina Medical Physics Corp. →

Other applicant names beginning “Aktina”

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

Aktina Medical Corporation 4