Data / Medical devices / United States / Varian Medical Systems, Inc.
Varian Medical Systems, Inc.: FDA-registered device maker in Atlanta, GA, United States, 1 510(k) clearance
Varian Medical Systems, Inc. is registered with the FDA (registration 3007157255) in Atlanta, GA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 15, 2018. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3007157255
- Address
- 3290 Northside Parkway NW Suite 400, Atlanta, GA, United States, 30327
- Owner or operator
- Varian Medical Systems, Inc (2914292)
- Roles
- Manufacturer
- First device listed
- March 16, 2018
- Registered through
- 2026
- Brand names listed
- Velocity
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 15, 2018 | K173636 | Velocity | LLZ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 25, 2013 | 67615 | Class II | Terminated | DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicians, physicists, dosimetrists, etc.) a means for comparison of medical imaging dat | An anomaly was detected such that, under certain conditions, a summed dose created by Velocity replaces the calculated dose from an approved plan in Eclipse when importing the dose from Velocity. | accessdata.fda.gov |
Compare with other makers
Updated February 15, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.