Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2939248

FEI Number

2939248

Entity Name

PROWESS, INC.

City/State/Country

Concord, CA, US

Establishment Address

5129 Commercial Circle, Concord, CA 94520, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PROWESS, INC. (Owner Number: 2939248)

Owner / Operator Contact Address

5129 Commercial Circle, Concord, CA 94520, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211760

PMA Number

N/A

All Registered Proprietary Names

Panther TPS Panther TPS Panther TPS Panther TPS Panther TPS Panther OIS Panther OIS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2010-07-30
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2008-10-06
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2016-07-12
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2026-06-03
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2010-07-30
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2013-01-11
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2021-11-24

Official Correspondent

Rick Smith

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PROWESS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K993675	Nomos Corp.	PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM	2000-09-05
K071992	Varian Medical Systems	HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)	2007-08-15
K253962	Radformation, Inc.	ClearCheck (RADCC V2.7)	2026-04-03
K003779	Arplay Medical S.A.	IMMOBILIZATION SYSTEM FOR ENT	2001-07-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2012	Elekta, Inc.	2	Dynamic Multileaf Collimator (DMLC) Shapes the radiation beam in treatment therapy.
Z-0038-2017	RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden	2	RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs.
Z-0004-2019	Varian Medical Systems	2	TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019	Varian Medical Systems	2	VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015	N/A	2	Proteus 235 Proton Therapy System for cancer treatment.

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2916710	Varian Medical Systems, Inc	PALO ALTO, CA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2939248. Last updated year: 2026. Please use registration number 2939248 when referencing this establishment in official correspondence.