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Jupiter Processing and Review Workstation

by GE Medical Systems, Inc.

510(k) K024137

Jupiter Processing and Review Workstation is a Class II device made by GE Medical Systems, Inc., cleared under FDA 510(k) K024137 on 15 Jan 2003, active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 · Special NumberK024137 Date15 Jan 2003ClearedStatusActive

Official records

Recalls

2 recalls · FDA

    • Terminated Z-1250-2011 FDA Unclassified (pre-2012) initiated 12 Jan 2011

    GE Healthcare has become aware of safety issues relevant for the Xeleris Workstation 1.0, 1.1, 2.0, 2.1, 3.0: 1. Measurements taken on the CT Images on the CT system are different from the Xeleris Workstation 2. Inaccurate PET SUV values may be calculated when data is retrieved from PACS after being processed in the Xeleris. 3. Wrong marking of Early and Late result series on display in Bra

    • Terminated Z-0537-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010

    GE Healthcare has become aware of inaccurate user protocol setup associated with the Thyroid Uptake Index application on certain Xeleris workstations(1.0, 1.1, 2.0, 2.1) that may impact patient safety. Inaccurate protocol setup by the user while using Thyroid Uptake Index application has been identified on certain Xeleris workstations. Incorrect protocol setup during clinical data acquisition a

Timeline

3 dated events

  1. Cleared FDA 510(k) K024137
  2. Recall initiated FDA recalls Z-0537-2011
  3. Recall initiated FDA recalls Z-1250-2011

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  • Withdrawn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

Similar devices

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