510(k) Report

FDA applicant

Varian Assoc., Inc.

Mchenry, IL86 decisions1976–200022 recalls

FDA records 86 decisions for Varian Assoc., Inc. (Mchenry, IL) from 1976 to 2000: 86 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and JJQ (Colorimeter, Photometer, Spectrophotometer For…). Its devices cite 7 predicates, 3 of them its own earlier devices. 22 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 Varian Assoc., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Varian Assoc., Inc. since 2007.

Recalls per year

3in 2012

2007: 22008: 12009: 22010: 52011: 22012: 3
2007high 5 (2010) · low 0 (2013)2026

Class I Class II/III not classified

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

Planning a device like Varian Assoc., 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?

  • IYEAccelerator, Linear, Medical27decisions
  • JJQColorimeter, Photometer, Spectrophotometer For Clinical Use7decisions
  • KPQSystem, Simulation, Radiation Therapy6decisions
  • JXRAtomic Absorption Spectrophotometer, General Use6decisions
  • JAQSystem, Applicator, Radionuclide, Remote-Controlled5decisions
  • MUJSystem, Planning, Radiation Therapy Treatment3decisions

Also: KZR (3), IYO (3), HKP (3), IZO (2), KZQ (2), HQB (2).

Whose devices does it build on?

Its devices cite 7 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 49 times; 3 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.

  • K992762Brachyvision 6.0Varian Assoc., Inc. · 20007cite it
  • K952913Applicators for Varian Varisource Remote High Soes Rate AfterloaderVarian Assoc., Inc. · 19956cite it
  • K945383High Dose Rate AfterloaderVarian Assoc., Inc. · 19956cite it
  • K955844Applicators for Varian Varisource Remote High Dose Rate AfterloaderVarian Assoc., Inc. · 19963cite it
  • K000922Proton VisionVarian Assoc., Inc. · 20003cite it
  • K980601Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High Dose Rate AfterioaderVarian Assoc., Inc. · 19983cite it

What has FDA decided for it lately?

  • K000922Proton VisionVarian Assoc., Inc. · 2000
  • K992762Brachyvision 6.0Varian Assoc., Inc. · 20001 recall
  • K992751SomavisionVarian Assoc., Inc. · 2000
  • K992753Cadplan Plus: 3D Treatment Planning SystemVarian Assoc., Inc. · 1999
  • K990085Millennium MLC -120Varian Assoc., Inc. · 19992 recalls
  • K980601Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High Dose Rate AfterioaderVarian Assoc., Inc. · 1998
  • K955844Applicators for Varian Varisource Remote High Dose Rate AfterloaderVarian Assoc., Inc. · 1996
  • K954467Cadplan BTVarian Assoc., Inc. · 1996

All 86 as Varian Assoc., Inc. →

What has been recalled?

22 recalls linked to its devices; the latest:

  • K081188Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number…Aug 14, 2012Class II
  • K050442Varian brand 52-leaf Millennium MLC multileaf collimator; Reference/FSCA Identifier…Jan 16, 2012
  • K050442Varian brand Varian 52-leaf Standard MLC multileaf collimator; Reference/FSCA…Jan 16, 2012
  • K112839Varian High Energy Linear Accelerator, C-Series Clinac, Reference/FSCA Identifier…Nov 28, 2011
  • K990085Varian brand Varian Clinac Accelerators with Mark, Millennium MLC 120 (Multileaf…Nov 10, 2011
  • K070094Varian Radiotherapy delivery system (C-Series Clinac, Trilogy and Novalis Tx), model…Jun 23, 2010

Other applicant names beginning “Varian”

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

Varian Medical Systems, Inc. 206Varian Canada, Inc. 7Varian, Inc. 5Varian Medical Systems, Oncology Systems 4Varian Medical Systems, X-Ray Products-Infimed 2