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BeamSite

by Doseoptics LLC

BeamSite is a Class II device made by Doseoptics LLC, cleared under FDA 510(k) K212606 on 15 Sep 2021 and listed in FDA GUDID since 10 Aug 2023 (UDI-DI 00860009184503), active as of 8 Jun 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 8 Jun 2026

Documents

510(k) K212606

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Jun 2026.

Regulatory status

as of registry sync 8 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860009184503 UDI-DI Date10 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK212606 Date15 Sep 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K212606 decided 15 Sep 2021 Active
  • FDA GUDID UDI-DI 00860009184503 listed 10 Aug 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K212606
  2. Listed FDA GUDID 00860009184503

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Radiation therapy software
Model / reference
BeamSite
Primary DI / UDI-DI
00860009184503
510(k) Number
FDA product code
IYE
GMDN term
Radiation therapy software
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiation therapy softwareRadiation therapy system workstation, multi-purpose

Similar devices in this category

Other devices filed under Radiation therapy software.

Other devices from Doseoptics LLC

  • BeamSite

    Class II

  • BeamSite

    Class II

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
Other properties (12, all answered No)