Varian Canada, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Varian Canada, Inc.” (first 1991, latest 1995), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 63 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 5 | 5 |
| IZH | System, X-Ray, Mammographic | 1 | 1 |
| KPR | System, X-Ray, Stationary | 1 | 1 |
Review panels
- Radiology (7)
Most recent Varian Canada, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953582 | HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR | IZO | 1995-09-26 | 56 |
| K923455 | HFG 350, 650, 1050 | KPR | 1992-12-28 | 167 |
| K920938 | VJW2919 PNEUMATIC COMPRESSION UPGRADE | IZH | 1992-06-17 | 111 |
| K913234 | VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLY | IZO | 1991-09-23 | 63 |
| K910820 | VPW 2877E6 X-RAY POWER SUPPLY | IZO | 1991-03-07 | 10 |
| K904169 | VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY | IZO | 1991-02-19 | 161 |
| K905855 | VPW2877E7 X RAY POWER SUPPLY | IZO | 1991-02-13 | 54 |
Recalls
openFDA lists no recalls under a recalling firm named Varian Canada, 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 Assoc., Inc. (86 510(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 Canada, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Varian Canada, Inc.” (first 1991, latest 1995), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Varian Canada, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Varian Canada, Inc. is 63 days.
Which FDA product codes appear under Varian Canada, Inc.?
The most frequent FDA product codes under this applicant name are IZO (Generator, High-Voltage, X-Ray, Diagnostic, 5); IZH (System, X-Ray, Mammographic, 1); KPR (System, X-Ray, Stationary, 1).
Next steps
- See all 7 Varian Canada, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IZO, Varian Canada, 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.