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Best TPS 209867

by Best Nomos

Best TPS 209867 is a Class II device made by Best Nomos, cleared under FDA 510(k) K981678 on 11 Dec 1998 and listed in FDA GUDID since 31 Oct 2016 (UDI-DI 00852656007052), 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) K981678

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 Number00852656007052 UDI-DI Date31 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK981678 Date11 Dec 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K981678 decided 11 Dec 1998 Active
  • FDA GUDID UDI-DI 00852656007052 listed 31 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K981678
  2. Listed FDA GUDID 00852656007052

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Best TPS
Generic name
Radiation therapy software
Model / reference
209867
Primary DI / UDI-DI
00852656007052
510(k) Number
FDA product code
MUJ
GMDN term
Radiation therapy software
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

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Other devices from Best Nomos

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Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)