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Panther OIS 3.5

by Prowess, Inc.

Panther OIS 3.5 is a Class II device made by Prowess, Inc., cleared under FDA 510(k) K211760 on 28 Sep 2021 and listed in FDA GUDID since 22 Sep 2026 (UDI-DI 00859032007385), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K211760

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00859032007385 UDI-DI Date22 Sep 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK211760 Date28 Sep 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K211760 decided 28 Sep 2021 Active
  • FDA GUDID UDI-DI 00859032007385 listed 22 Sep 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K211760
  2. Listed FDA GUDID 00859032007385

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Panther OIS
Generic name
Radiology information system application software
Model / reference
3.5
Primary DI / UDI-DI
00859032007385
510(k) Number
FDA product code
MUJ
GMDN term
Radiology information system application software
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K211760)

and 4 more cleared under K211760

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)