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ASiR-V 1.0

by GE Healthcare Japan Corporation

ASiR-V 1.0 is a Class II device made by GE Healthcare Japan Corporation, cleared under FDA 510(k) K133640 on 25 Mar 2014 (1 earlier submission) and listed in FDA GUDID since 25 Oct 2017 (UDI-DI 00840682134972), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840682134972 UDI-DI Date25 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK133640 Date25 Mar 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K133640 decided 25 Mar 2014 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00840682134972 listed 25 Oct 2017 Listed

Recalls

2 recalls · FDA

    • Terminated Z-2581-2018 FDA Class II initiated 24 May 2018

    Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

    • Terminated Z-2184-2017 FDA Class II initiated 19 May 2017

    It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Timeline

5 dated events

  1. Cleared FDA 510(k) K132410
  2. Cleared FDA 510(k) K133640
  3. Recall initiated FDA recalls Z-2184-2017
  4. Listed FDA GUDID 00840682134972
  5. Recall initiated FDA recalls Z-2581-2018

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ASiR-V
Generic name
CT system application software
Model / reference
1.0
Primary DI / UDI-DI
00840682134972
510(k) Number
FDA product code
JAK
GMDN term
CT system application software
Device class
Class II
Regulation number
892.1750
GUDID distribution status
In Commercial Distribution

Related devices

Category: CT system application software

Cleared under the same submission (K132410)

Cleared under the same submission (K133640)

Similar devices in this category

Other devices filed under CT system application software.

Other devices from GE Healthcare Japan Corporation

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    Class IIa

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    Class IIa

  • Optima CT660

    Class IIb

  • C2-9VN-D

    Class II

See all devices from GE Healthcare Japan Corporation →

Properties

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