← Back to catalogue

R-20j

FDA UDI

Class II (US FDA UDI)

by Shimadzu Corp.

Identity

Trade Name
R-20J FDA UDI
Generic Name
Manual-aperture-control diagnostic x-ray system collimator, non-motorized FDA UDI
Model / Reference
563-55050-31 FDA UDI

Identifiers

Primary DI / UDI-DI
04540217059539 FDA UDI
510(k) Number
K101036 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

Yes

FDA UDI

Category: Manual-aperture-control diagnostic x-ray system collimator, non-motorized

R-20j by Shimadzu Corp. — 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

K101036 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Shimadzu Corp.

Sources (1)

  • FDA UDI 45da099a-fe7c-44f4-b850-a5f0c6d0beca 33 fields · synced May 30, 2026