Skip to content

Panther TPS v5.6

by Prowess, Inc.

Panther TPS v5.6 is a Class II device made by Prowess, Inc., cleared under FDA 510(k) K193459 on 27 Apr 2020 (4 earlier submissions) and listed in FDA GUDID since 1 Nov 2021 (UDI-DI 00859032007064), 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 Number00859032007064 UDI-DI Date1 Nov 2021ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK193459 Date27 Apr 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193459 decided 27 Apr 2020 Active· +4 more in the status table
  • FDA GUDID UDI-DI 00859032007064 listed 1 Nov 2021 Listed

Timeline

6 dated events

  1. Cleared FDA 510(k) K984196
  2. Cleared FDA 510(k) K032456
  3. Cleared FDA 510(k) K083502
  4. Cleared FDA 510(k) K101076
  5. Cleared FDA 510(k) K193459
  6. Listed FDA GUDID 00859032007064

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Panther TPS
Generic name
Radiation therapy software
Model / reference
v5.6
Primary DI / UDI-DI
00859032007064
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
  • Manufacturing date
Other properties (13, all answered No)