Data / Medical devices / United States / Prowess, Inc.
Prowess, Inc.: FDA-registered device maker in Concord, CA, United States, 10 510(k) clearances
Prowess, Inc. is registered with the FDA (registration 2939248) in Concord, CA, United States. It lists 3 device types. The FDA files 10 510(k) clearances under its listings, the newest dated December 15, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2939248
- Address
- 5129 Commercial Circle, Concord, CA, United States, 94520
- Owner or operator
- PROWESS, INC. (2939248)
- Roles
- Manufacturer
- First device listed
- October 6, 2008
- Registered through
- 2027
- Brand names listed
- Panther Brachy, Panther OIS, Panther TPS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | accessdata.fda.gov |
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Manufacturer | accessdata.fda.gov |
| System, Radiation Therapy, Radionuclide | IWB | 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 |
|---|---|---|---|---|---|---|
| December 15, 2023 | K231825 | Panther TPS | MUJ | Substantially Equivalent | Prowess, Inc. | accessdata.fda.gov |
| September 28, 2021 | K211760 | Panther OIS | IYE | Substantially Equivalent | Prowess, Inc. | accessdata.fda.gov |
| April 27, 2020 | K193459 | Panther Stereotactic | MUJ | Substantially Equivalent | Prowess, Inc. | accessdata.fda.gov |
| December 11, 2015 | K143514 | Panther StereoSeed | MUJ | Substantially Equivalent | Prowess, Inc. | accessdata.fda.gov |
| December 21, 2012 | K122616 | PANTHER OIS/R & V MODEL VERSION 2.0 | IYE | Substantially Equivalent | Prowess, Inc. | accessdata.fda.gov |
| July 27, 2010 | K101076 | PROWESS PANTHER PROARC, MODEL VERSION 5.0 | MUJ | Substantially Equivalent | Prowess, Inc. | accessdata.fda.gov |
| June 18, 2010 | K100801 | PUMA MODEL VERSION 1.0 | IYE | Substantially Equivalent | Prowess, Inc. | accessdata.fda.gov |
| May 5, 2009 | K083502 | PANTHER REALART, MODEL 4.7 | MUJ | Substantially Equivalent | Prowess, Inc. | accessdata.fda.gov |
| October 16, 2003 | K032456 | PROWESS | MUJ | Substantially Equivalent | Prowess, Inc. | accessdata.fda.gov |
| December 11, 1998 | K984196 | MODIFICATION TO PROWESS PRO-SIM | MUJ | Substantially Equivalent | Ssgi Prowess Systems | accessdata.fda.gov |
Compare with other makers
- All makers of System, Planning, Radiation Therapy Treatment
- All makers of System, Radiation Therapy, Radionuclide
- All makers of Accelerator, Linear, Medical
Updated December 15, 2023. 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.