Varian Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 206 510(k) clearances under the applicant name “Varian Medical Systems, Inc.” (first 1997, latest 2026), across 15 product codes in 3 review panels. Median 510(k) review time under this name: 82 days. Since 2017 the median was 98 days, against 113 days for all cleared 510(k)s in the same product codes. 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 | 7 | 86 |
| 2013 | 7 | 63 |
| 2014 | 15 | 91 |
| 2015 | 11 | 62 |
| 2016 | 6 | 128 |
| 2017 | 10 | 117 |
| 2018 | 12 | 81 |
| 2019 | 5 | 28 |
| 2020 | 5 | 60 |
| 2021 | 6 | 40 |
| 2022 | 7 | 85 |
| 2023 | 12 | 108 |
| 2024 | 15 | 117 |
| 2025 | 10 | 96 |
| 2026 | 8 | 178 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Varian Medical Systems, Inc. took a median 98 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 83 | 83 |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 59 | 59 |
| MUJ | System, Planning, Radiation Therapy Treatment | 33 | 33 |
| LHN | System, Radiation Therapy, Charged-Particle, Medical | 8 | 8 |
| JAK | System, X-Ray, Tomography, Computed | 4 | 4 |
| KPQ | System, Simulation, Radiation Therapy | 4 | 4 |
| GEH | Unit, Cryosurgical, Accessories | 3 | 3 |
| KXK | Source, Brachytherapy, Radionuclide | 3 | 3 |
| KRD | Device, Vascular, For Promoting Embolization | 2 | 2 |
| NEY | System, Ablation, Microwave And Accessories | 2 | 2 |
Plus 5 more product codes.
Review panels
- Radiology (199)
- General and Plastic Surgery (5)
- Cardiovascular (2)
Most recent Varian Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261856 | Halcyon, Ethos Radiotherapy System (5.0) | IYE | 2026-08-03 | 60 |
| K261306 | AI Contouring (VA10A) | QKB | 2026-07-10 | 81 |
| K260750 | Virtual Cone (1.0) | MUJ | 2026-07-08 | 124 |
| K253026 | Respiratory Gating for Scanners (2.1) | JAK | 2026-06-04 | 258 |
| K252717 | MAASTRO Rectal Applicator Set | JAQ | 2026-05-20 | 265 |
| K252815 | ProBeam 360 Proton Therapy System v3.0 | LHN | 2026-04-23 | 231 |
| K252304 | syngo.via RT Image Suite VC10 | MUJ | 2026-03-18 | 237 |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0) | IYE | 2026-01-21 | 126 |
| K252919 | IDENTIFY (5.0) | IYE | 2025-12-16 | 95 |
| K252884 | Guided Aarhus Applicator Set | JAQ | 2025-11-19 | 70 |
196 earlier clearances. See the full list in Caduvo.
Recalls
63 product recalls in 52 recall events; 0 initiated in the last five years. Most recent: 2019-08-12.
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.
Device clinical trials
An industry sponsor named Varian Medical Systems, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03113955: STOPPER CHINA:With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma (Completed, started 2017-10-24)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Varian Medical Systems, Inc. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
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 Assoc., Inc. (86 510(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 Medical Systems, Inc.?
FDA lists 206 510(k) clearances under the applicant name “Varian Medical Systems, Inc.” (first 1997, latest 2026), across 15 product codes in 3 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 Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Varian Medical Systems, Inc. is 82 days. Since 2017: 98 days, versus 113 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Varian Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 83); JAQ (System, Applicator, Radionuclide, Remote-Controlled, 59); MUJ (System, Planning, Radiation Therapy Treatment, 33).
Next steps
- See all 206 Varian Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Varian Medical Systems, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.