Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Panther TPS

K-Number: K231825 · 2023-12-15

ApplicantProwess, Inc.
Decision Date2023-12-15
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Panther TPS is a medical device manufactured by Prowess, Inc.. It received FDA 510(k) clearance on 2023-12-15 under approval number K231825. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Panther TPS?

Panther TPS is a medical device that received FDA 510(k) clearance on 2023-12-15. It is manufactured by Prowess, Inc.. The 510(k) number is K231825.

When was Panther TPS approved by the FDA?

Panther TPS received FDA 510(k) clearance on 2023-12-15, under approval number K231825.

What company makes Panther TPS?

Panther TPS is manufactured by Prowess, Inc..

What is the FDA product code for Panther TPS?

The FDA product code for Panther TPS is MUJ.

Other Devices by Prowess, Inc.

K193459Panther Stereotactic K211760Panther OIS

Related Devices (Code: MUJ)

K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. K161136Precision Treatment Planning SystemAccuray Incorporated K160093RayStationRaySearch Laboratories AB (PUBL) K151435MRCATPhilips Medical Systems MR Finland K153368Radiance V3Gmv Soluciones Globales Internet S.A.U. K170750RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose ReviewBrainlab AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑