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Cardiac Vx

by GE Medical Systems, LLC

510(k) K121762

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK121762 Date18 Jan 2013ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-1511-2014 FDA Class II initiated 7 Apr 2014

    GE Healthcare has recently become aware of a potential safety issue due to higher than actual flow values reported on CardiacVX and CardiacVX Flow running on Advantage Workstation.

Timeline

2 dated events

  1. Cleared FDA 510(k) K121762
  2. Recall initiated FDA recalls Z-1511-2014

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LLZ
Device class
Class II
Regulation
21 CFR Part 892.2050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cardiac Vx is a medical imaging system. It is classified as a Radiology device. The device has a product code of LLZ.

The Cardiac Vx is supplied by GE Medical Systems, LLC and has received FDA 510(k) clearance, with the reference number K121762. It was cleared on January 18, 2013. The device is used in the field of Radiology.

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

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