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Panther Brachy version 5.0

by Prowess, Inc. 2 variants

Panther Brachy version 5.0 is a Class II device made by Prowess, Inc., cleared under FDA 510(k) K143514 on 11 Dec 2015 (2 earlier submissions) and listed in FDA GUDID since 11 Jun 2018 (UDI-DI 00859032007002), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00859032007002 UDI-DI Date11 Jun 2018ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK143514 Date11 Dec 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K143514 decided 11 Dec 2015 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00859032007002 listed 11 Jun 2018 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K984196
  2. Cleared FDA 510(k) K032456
  3. Cleared FDA 510(k) K143514
  4. Listed FDA GUDID 00859032007002

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Panther Brachy
Generic name
Radiation therapy software
Model / reference
version 5.0
Primary DI / UDI-DI
00859032007002
510(k) Number
FDA product code
MUJ
GMDN term
Radiation therapy software
Device class
Class II
Regulation number
892.5050
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code MUJ (System, Planning, Radiation Therapy Treatment).

Other devices from Prowess, Inc.

See all devices from Prowess, Inc. →

Properties

  • Lot / batch number
Other properties (14, all answered No)