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510(k) K231825

Panther TPS by Prowess, Inc. — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2023
Date Received
June 21, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Planning, Radiation Therapy Treatment
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Other clearances by Prowess, Inc.

  • K211760 — Panther OIS (September 28, 2021)
  • K193459 — Panther Stereotactic (April 27, 2020)
  • K143514 — Panther StereoSeed (December 11, 2015)
  • K122616 — PANTHER OIS/R & V MODEL VERSION 2.0 (December 21, 2012)
  • K101076 — PROWESS PANTHER PROARC, MODEL VERSION 5.0 (July 27, 2010)
  • K100801 — PUMA MODEL VERSION 1.0 (June 18, 2010)
  • K083502 — PANTHER REALART, MODEL 4.7 (May 5, 2009)
  • K032456 — PROWESS (October 16, 2003)

Other clearances for product code MUJ

  • K252304 — syngo.via RT Image Suite VC10 (March 18, 2026)
  • K252002 — Monaco RTP System (6.3) (February 19, 2026)
  • K260308 — TrueFit Bolus (February 19, 2026)
  • K253091 — ART-Plan+ (v3.1.0) (December 23, 2025)
  • K252109 — RayStation (2024A SP3) (December 22, 2025)
  • K252863 — ClearCalc Model RADCA V2.6 (December 19, 2025)
  • K250963 — PlanOne 1 (November 20, 2025)
  • K250064 — Dose+ (1.0) (September 4, 2025)
  • K250440 — RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (June 17, 2025)
  • K242992 — RayCare (2024A SP1) (April 17, 2025)