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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
Device Name
Critical Care Suite 2.0, Designated Medical Device FDA UDI
Model / Reference
2.0 FDA UDI
Description
Critical Care Suite 2.0, Designated Medical Device FDA UDI

Identifiers

Primary DI / UDI-DI
00195278217981 FDA UDI
510(k) Number
K183182 FDA UDI
FDA Product Code
QFM FDA UDI
GMDN Term
X-ray image interpretive software FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

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.

Cleared under the same submission

K183182 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ge Medical Systems, Inc.

Sources (1)

  • FDA UDI 0fe701aa-b562-487c-b3b3-9d925bf34ea8 34 fields · synced May 30, 2026