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DoseCHECK 12170000

by Sun Nuclear Corporation

DoseCHECK 12170000 is a Class II device made by Sun Nuclear Corporation, cleared under FDA 510(k) K150848 on 20 May 2015 and listed in FDA GUDID since 14 Jan 2017 (UDI-DI B016121700000), 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) K150848

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 NumberB016121700000 UDI-DI Date14 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK150848 Date20 May 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K150848 decided 20 May 2015 Active
  • FDA GUDID UDI-DI B016121700000 listed 14 Jan 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K150848
  2. Listed FDA GUDID B016121700000

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
DoseCHECK
Generic name
Radiation therapy software
Model / Ref / Catalog
12170000
Primary DI / UDI-DI
B016121700000
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 software

Similar devices in this category

Other devices filed under Radiation therapy software.

Other devices from Sun Nuclear Corporation

See all devices from Sun Nuclear Corporation →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)