Who else makes this device?

Name: R-300
Brand: R-300

Radiology › DiagnosticCollimator, Automatic, Radiographic

R-300

2 catalogue numbers from 566-17970-85, listed by Shimadzu Corp., United States, under Collimator, Automatic, Radiographic. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26

5manufacturers in China registered for this device type

2catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Beijing (2), Zhejiang (2), Jiangsu (1).

Chinese manufacturers registered for FDA product code IZW
Manufacturer	City	Province	Registered as	Device types
Suzhou Shangchuang Technology Service Co., Ltd.	Suzhou	Jiangsu	Manufacturer	23
GE Hangwei Medical Systems Co., Ltd.	Beijing	Beijing	Specification developer	22
GE Healthcare (China) Co., Ltd.	Beijing	Beijing	Specification developer	22
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	IZW
Device type	Collimator, Automatic, Radiographic
Device class	Class 2
Regulation	21 CFR 892.1610
510(k)	K101039
Record published	2016-10-03
Record revised	2025-05-28 (version 4)

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
566-17970-85		In distribution
566-17970-05		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Claymount	Varex Imaging Nederland B.V.	30
Varex Imaging	Varex Imaging Nederland B.V.	17
Ralco srl	Ralco SRL	9
Linear IV	Carestream Health, Inc.	2
iRay	iRay Imaging Technology (Haining) Limited	1
Vareximaging	Varex Imaging Nederland B.V.	1
Collimator Cradle 512 asm	Philips Digital Mammography Sweden AB	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K101039	2010-09-20
K090578	2009-11-06

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.