510(k) Report

FDA applicant

Diacor, Inc.

Salt Lake City, UT10 decisions1986–20130 recalls

FDA records 10 decisions for Diacor, Inc. (Salt Lake City, UT) from 1986 to 2013: 10 510(k) clearances. Most are in product codes IWE (Monitor, Patient Position, Light-Beam) and 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 Diacor, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • IWEMonitor, Patient Position, Light-Beam4decisions
  • IYEAccelerator, Linear, Medical4decisions
  • FRZDevice, Patient Transfer, Powered1decision
  • IXIBlock, Beam-Shaping, Radiation Therapy1decision

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 2 times; 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.

  • K872489CentraliteDiacor, Inc. · 19871cites it
  • K121929Zephyr 'X-Series Patient Transfer SledDiacor, Inc. · 20131cites it

What has FDA decided for it lately?

  • K121929Zephyr 'X-Series Patient Transfer SledDiacor, Inc. · 2013
  • K050888Integra Immobilization SystemDiacor, Inc. · 2005
  • K954414Centralite BackpointerDiacor, Inc. · 1995
  • K953046Peri-PusherDiacor, Inc. · 1995
  • K950112Centralite (R)-DLL SeriesDiacor, Inc. · 1995
  • K934566RadassistDiacor, Inc. · 1993
  • K930246MammorxDiacor, Inc. · 1993
  • K893398Centralite BackpointerDiacor, Inc. · 1989

All 10 as Diacor, Inc. →