Who else makes this device?

Name: R-300
Brand: R-300

Radiology › DiagnosticCollimator, Manual, Radiographic

R-300

3 catalogue numbers from 566-17970-50, listed by Shimadzu Corp., United States, under Collimator, Manual, Radiographic. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

3catalogue numbers in this listing

3510(k) clearances naming this product code

Who Else Makes It

All of them in Zhejiang.

Chinese manufacturers registered for FDA product code IZX
Manufacturer	City	Province	Registered as	Device types
iRay Imaging Technology (Haining) Limited	Haining	Zhejiang	Contract manufacturer	6
Fairy Medical Electrics(Jiaxing)Co., Ltd.	Jiaxing	Zhejiang	Manufacturer	3

Record

Regulatory record for R-300
Listed by	Shimadzu Corp., United States
FDA product code	IZX
Device type	Collimator, Manual, Radiographic
Device class	Class 2
Regulation	21 CFR 892.1610
510(k)	K101039
Record published	2020-04-03
Record revised	2025-05-28 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for R-300
Catalogue number	Size	Status
566-17970-50		In distribution
566-17970-90		In distribution
566-25407-60		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Varex Imaging	Varex Imaging Nederland B.V.	80
Claymount	Varex Imaging Nederland B.V.	36
Huestis Medical Collimator	Huestis Machine Corp.	12
Collimare	Collimare, LLC	7
R-20J	Shimadzu Corp.	6
Linear MC 150	Carestream Health, Inc.	4
Ralco srl	Ralco SRL	3
iRay	iRay Imaging Technology (Haining) Limited	3
Drgem	Drgem Corporation	2
Rinn®	Dentsply LLC	2
Huestis Medical Collilmator	Huestis Machine Corp.	1
Summit X-ray Collimator	Summit Industries, LLC	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K101036	2010-08-26
K042840	2004-12-03
K031771	2003-08-21

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.