Varian Assoc., Inc.: FDA filings under this applicant name
FDA lists 86 510(k) clearances under the applicant name “Varian Assoc., Inc.” (first 1976, latest 2000), across 26 product codes in 5 review panels. Median 510(k) review time under this name: 60 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Siemens Healthineers, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 27 | 27 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 7 | 7 |
| JXR | Atomic Absorption Spectrophotometer, General Use | 6 | 6 |
| KPQ | System, Simulation, Radiation Therapy | 6 | 6 |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 5 | 5 |
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered | 3 | 3 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 3 | 3 |
| KZR | Chromatography (Liquid, Gel), Clinical Use | 3 | 3 |
| MUJ | System, Planning, Radiation Therapy Treatment | 3 | 3 |
| HQB | Photocoagulator And Accessories | 2 | 2 |
Plus 16 more product codes.
Review panels
- Radiology (55)
- Clinical Toxicology (12)
- Clinical Chemistry (8)
- Ophthalmic (7)
- Cardiovascular (1)
Most recent Varian Assoc., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000922 | PROTON VISION | MUJ | 2000-05-24 | 63 |
| K992762 | BRACHYVISION 6.0 | MUJ | 2000-03-09 | 205 |
| K992751 | SOMAVISION | KPQ | 2000-02-16 | 184 |
| K992753 | CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM | MUJ | 1999-09-03 | 18 |
| K990085 | MILLENNIUM MLC -120 | IYE | 1999-02-08 | 28 |
| K980601 | VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER | JAQ | 1998-10-21 | 246 |
| K955844 | APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER | JAQ | 1996-07-26 | 213 |
| K955774 | VARIS PORTALVISION | IYE | 1996-03-15 | 85 |
| K954467 | CADPLAN BT | JAQ | 1996-03-15 | 171 |
| K943224 | VARIAN MULTILEAF COLLIMATOR | IYE | 1996-02-02 | 577 |
76 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Varian Assoc., Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Varian Medical Systems, Inc. (206 510(k)s)
- Varian Canada, Inc. (7 510(k)s)
- Varian, Inc. (5 510(k)s)
- Varian Medical Systems, Oncology Systems (4 510(k)s)
- Varian Medical Systems, X-Ray Products-Infimed (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Varian Assoc., Inc.?
FDA lists 86 510(k) clearances under the applicant name “Varian Assoc., Inc.” (first 1976, latest 2000), across 26 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Varian Assoc., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Varian Assoc., Inc. is 60 days.
Which FDA product codes appear under Varian Assoc., Inc.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 27); JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use, 7); JXR (Atomic Absorption Spectrophotometer, General Use, 6).
Next steps
- See all 86 Varian Assoc., Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Varian Assoc., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.