CARESTREAM Image Suite

FDA UDI

Class II (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name: CARESTREAM Image Suite FDA UDI
Generic Name: Radiological PACS software FDA UDI
Device Name: IMAGE SUITE / V4 SW MEDICAL APP FDA UDI
Model / Reference: CARESTREAM Image Suite FDA UDI
Description: IMAGE SUITE / V4 SW MEDICAL APP FDA UDI

Identifiers

Catalog Number: 1055987 FDA UDI
Primary DI / UDI-DI: 60889971055989 FDA UDI
510(k) Number: K100094 FDA UDI
FDA Product Code: LLZ FDA UDI
GMDN Term: Radiological PACS software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2050 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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Radiological PACS software

CARESTREAM Image Suite by Carestream Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological PACS software.

AVIEW — CORELINE SOFT CO., LTD. · Class II
ThinkingNet — THINKING SYSTEMS CORP. · Class II
IMAGEGRID RADIOLOGY VIEWER SYSTEM — Candelis, Inc. · Class II
EAGLESOFT — PATTERSON TECHNOLOGY CENTER · Class II
QuantX — Qlarity Imaging · Class II
interWORKS — Avreo, Inc. · Class I
NovaPACS — Novarad Corporation · Class II
OrthoNext™ Platform System Software — Orthofix, Inc. · Class II

Cleared under the same submission

K100094 also covers:

CARESTREAM Image Suite — CARESTREAM HEALTH, INC.

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

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Manufacturer

Manufacturer: Carestream Health, Inc.

Sources (1)

FDA UDI eb474747-e645-43a8-ab3d-2dfe5e698f08 35 fields · synced Jun 8, 2026