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Linear Iv

FDA UDI

Class II (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name
LINEAR IV FDA UDI
Generic Name
Automatic-aperture-control diagnostic x-ray system collimator FDA UDI
Device Name
R40-CS-P LIN IV COLLIMATOR W/65 FT CABLE FDA UDI
Model / Reference
LINEAR IV FDA UDI
Description
R40-CS-P LIN IV COLLIMATOR W/65 FT CABLE FDA UDI

Identifiers

Catalog Number
6573778 FDA UDI
Primary DI / UDI-DI
60889976568811 FDA UDI
510(k) Number
K810598 FDA UDI
FDA Product Code
IZW FDA UDI
GMDN Term
Automatic-aperture-control diagnostic x-ray system collimator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1610 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Automatic-aperture-control diagnostic x-ray system collimator

Linear Iv by Carestream Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Automatic-aperture-control diagnostic x-ray system collimator.

Cleared under the same submission

K810598 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Carestream Health, Inc.

Sources (1)

  • FDA UDI 3472d461-96f4-48ce-9f9f-9fce0cba8ed7 35 fields · synced Jun 8, 2026