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Critical Care Suite 2.0

by GE Medical Systems, L.L.C.

Critical Care Suite 2.0 is a Class II device made by GE Medical Systems, L.L.C., cleared under FDA 510(k) K211161 on 29 Oct 2021 (1 earlier submission) and listed in FDA GUDID since 4 May 2022 (UDI-DI 00195278217981), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00195278217981 UDI-DI Date4 May 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK211161 Date29 Oct 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K211161 decided 29 Oct 2021 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00195278217981 listed 4 May 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K183182
  2. Cleared FDA 510(k) K211161
  3. Listed FDA GUDID 00195278217981

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Critical Care Suite
Generic name
X-ray image interpretive software
Model / reference
2.0
Primary DI / UDI-DI
00195278217981
510(k) Number
FDA product code
QFM, QIH
GMDN term
X-ray image interpretive software
Device class
Class II
Regulation number
892.2080, 892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: X-ray image interpretive software

Cleared under the same submission (K183182)

Cleared under the same submission (K211161)

Similar devices

Other devices filed under FDA product code QFM (Radiological computer-assisted prioritization software for lesions).

Other devices from GE Medical Systems, L.L.C.

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See all devices from GE Medical Systems, L.L.C. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)