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Discovery CT750 Hd

by GE Medical Systems, LLC

510(k) K120833

Discovery CT750 Hd is a Class II device made by GE Medical Systems, LLC, cleared under FDA 510(k) K120833 on 12 Jun 2012, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 · Special NumberK120833 Date12 Jun 2012ClearedStatusActive

Official records

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0609-2025 FDA Class II initiated 5 Nov 2024

    GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.

Timeline

2 dated events

  1. Cleared FDA 510(k) K120833
  2. Recall initiated FDA recalls Z-0609-2025

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  • Withdrawn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
JAK
Device class
Class II
Regulation
21 CFR Part 892.1750
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

Devices cleared under K120833

6 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K120833
UDI-DISize and differences
Revolution Discovery CT
GE Medical Systems, L.L.C.
Discovery CT00840682102490 —On the market
Revolution Discovery CT A
GE Medical Systems, L.L.C.
Discovery CT A00840682125574 —On the market
Revolution Frontier
GE Hangwei Medical Systems Company Ltd.
Frontier00840682137553 —On the market
Revolution Frontier ES
GE Hangwei Medical Systems Company Ltd.
Frontier ES00195278362247 —On the market
Revolution Frontier Gen 3_HD Refresh Package
GE Hangwei Medical Systems Company Ltd.
B79832DA / Frontier Gen 3_HD Refresh Package00195278435675 —On the market
Revolution Frontier MDR
GE Hangwei Medical Systems Company Ltd.
Frontier MDR00195278362230 —On the market

Similar devices

Other devices filed under FDA product code JAK (System, X-Ray, Tomography, Computed).

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