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Portable Dosimeter

by Best Medical Canada, Ltd.

Portable Dosimeter is a MOSFET radiation therapy dosimetry system (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by Best Medical Canada, Ltd., cleared under FDA 510(k) K092285 on 28 Aug 2009 and listed in FDA GUDID since 30 Sep 2016 (UDI-DI 07540146000098), active as of 23 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 23 Oct 2026

Documents

510(k) K092285

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07540146000098 UDI-DI Date30 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK092285 Date28 Aug 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K092285 decided 28 Aug 2009 Active
  • FDA GUDID UDI-DI 07540146000098 listed 30 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K092285
  2. Listed FDA GUDID 07540146000098

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Portable
Generic name
MOSFET radiation therapy dosimetry system
Model / reference
Dosimeter
Primary DI / UDI-DI
07540146000098
510(k) Number
FDA product code
IYE
GMDN term
MOSFET radiation therapy dosimetry system
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: MOSFET radiation therapy dosimetry system

Similar devices

Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).

Other devices from Best Medical Canada, Ltd.

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)