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X-ray beam limiting device

FDA UDI

Class II (US FDA UDI)

by Canon Medical Systems Corporation

Identity

Trade Name
X-ray beam limiting device FDA UDI
Generic Name
Automatic-aperture-control diagnostic x-ray system collimator FDA UDI
Model / Reference
BLR-15AA FDA UDI

Identifiers

Primary DI / UDI-DI
04987670101670 FDA UDI
510(k) Number
K133553 FDA UDI
FDA Product Code
KPW 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

X-ray beam limiting device by Canon Medical Systems Corporation — 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

K133553 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Canon Medical Systems Corporation

Sources (1)

  • FDA UDI 43aefa4a-bc33-40d0-b4f3-bc0d4edd6e6d 34 fields · synced Jun 8, 2026