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Linear Mc 150

FDA UDI

Class II (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name
LINEAR MC 150 FDA UDI
Generic Name
Manual-aperture-control diagnostic x-ray system collimator, non-motorized FDA UDI
Device Name
R40-M-P PROGENY MC150 MANUAL COLLIMATOR FDA UDI
Model / Reference
LINEAR MC 150 FDA UDI
Description
R40-M-P PROGENY MC150 MANUAL COLLIMATOR FDA UDI

Identifiers

Catalog Number
1013309 FDA UDI
Primary DI / UDI-DI
60889976567159 FDA UDI
510(k) Number
K810598 FDA UDI
FDA Product Code
IZX FDA UDI
GMDN Term
Manual-aperture-control diagnostic x-ray system collimator, non-motorized 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: Manual-aperture-control diagnostic x-ray system collimator, non-motorized

Linear Mc 150 by Carestream Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual-aperture-control diagnostic x-ray system collimator, non-motorized.

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 6c7ee6e1-a10a-4cfe-a918-00ca999f0118 35 fields · synced Jun 8, 2026