Critical Care Suite

FDA UDI

Class II (US FDA UDI)

by Ge Medical Systems, Inc.

Identity

Trade Name: Critical Care Suite FDA UDI
Generic Name: X-ray image interpretive software FDA UDI
Model / Reference: 1.0 FDA UDI

Identifiers

Primary DI / UDI-DI: 00840682146340 FDA UDI
510(k) Number: K183182 FDA UDI
FDA Product Code: QFM FDA UDI
KPS FDA UDI
GMDN Term: X-ray image interpretive software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2080 FDA UDI
892.1200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: X-ray image interpretive software

Critical Care Suite by Ge Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as X-ray image interpretive software.

Annalise Triage — Annalise-Ai Pty , Ltd. · Class II
e-CTP — BRAINOMIX LIMITED · Class II
Imbio RV/LV — Imbio, LLC · Class II
InferRead CT Stroke.AI — Infervision US Inc · Class II
Imbio RV/LV — Imbio, LLC · Class II
Triage LVO — BRAINOMIX LIMITED · Class II
Triage Stroke — BRAINOMIX LIMITED · Class II
InferRead Lung CT.AI 2.1.2.1 — Infervision US Inc · Class II

Cleared under the same submission

K183182 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Ge Medical Systems, Inc.

Sources (1)

FDA UDI 921a9695-bc59-4610-91fa-c80d0b5636b8 33 fields · synced Jun 6, 2026