Elite CR System

FDA UDI

Class II (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name: Elite CR System FDA UDI
Generic Name: Computed radiography digital imaging scanner FDA UDI
Device Name: Elite CR System FDA UDI
Model / Reference: Elite CR System FDA UDI
Description: Elite CR System FDA UDI

Identifiers

Catalog Number: 1794551 FDA UDI
Primary DI / UDI-DI: 60889971794550 FDA UDI
510(k) Number: K020635 FDA UDI
FDA Product Code: MQB FDA UDI
GMDN Term: Computed radiography digital imaging scanner FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1680 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Computed radiography digital imaging scanner

Elite CR System by Carestream Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Computed radiography digital imaging scanner.

FUJI IMAGING PLATE — FUJIFILM Corporation · Class I
CANON INC. — CANON INC. · Class II
DX-M — Agfa Corp. · Class II
FUJI IMAGING PLATE — FUJIFILM Corporation · Class I
CR-IR 392 — FUJIFILM Corporation · Class II
CANON INC. — CANON INC. · Class II
Radlink CR Pro 2200 — RADLINK, INC. · Class II
GMR40 Retrofit Kit — Neurologica Corporation · Class II

Cleared under the same submission

K020635 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: Carestream Health, Inc.

Sources (1)

FDA UDI e26cf497-438f-4aee-b316-9ef41fb95a53 35 fields · synced Jun 8, 2026