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Varian DoseLab Pro 7.0

by Varian Medical Systems, Inc.

Varian DoseLab Pro 7.0 is a Class II device made by Varian Medical Systems, Inc., cleared under FDA 510(k) K141230 on 27 Aug 2014 and listed in FDA GUDID since 8 Nov 2019 (UDI-DI 00899475002417), active as of 8 Nov 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 Nov 2026

Documents

510(k) K141230

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00899475002417 UDI-DI Date8 Nov 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK141230 Date27 Aug 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K141230 decided 27 Aug 2014 Active
  • FDA GUDID UDI-DI 00899475002417 listed 8 Nov 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K141230
  2. Listed FDA GUDID 00899475002417

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Varian DoseLab Pro
Generic name
Radiation therapy software
Model / reference
7.0
Primary DI / UDI-DI
00899475002417
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

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Properties

  • Lot / batch number
Other properties (14, all answered No)