Who else makes this device?

Name: Pediatric Chair (No accessories)
Brand: Pediatric Chair (No accessories)

Radiology › DiagnosticTable, Radiographic, Tilting

Pediatric Chair (No Accessories)

Catalogue number CH-01, listed by Octostop, Inc., Canada, under Table, Radiographic, Tilting. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

All of them in Beijing.

Chinese manufacturers registered for FDA product code IXR
Manufacturer	City	Province	Registered as	Device types
GE Hangwei Medical Systems Co., Ltd.	Beijing	Beijing	Specification developer	22
GE Healthcare (China) Co., Ltd.	Beijing	Beijing	Specification developer	22

Record

Regulatory record for Pediatric Chair (No accessories)
Listed by	Octostop, Inc., Canada
FDA product code	IXR
Device type	Table, Radiographic, Tilting
Device class	Class 2
Regulation	21 CFR 892.1980
Establishment	Manufacturer
Record published	2017-11-16
Record revised	2018-03-29 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied as a kit	Yes
Label carries	expiry date, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Pediatric Chair (No accessories)
Catalogue number	Size	Status
CH-01		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Oakworks Medical	Oakworks, Inc.	265
Image Diagnostics Inc	Image Diagnostics, Inc.	41
Aadco	Aadco Medical, Inc.	28
Medstone	Stille AB	17
Surgical C Arm Table	Biodex Medical Systems, Inc.	12
Aadco Imaging Table	Aadco Medical, Inc.	4
Sonesta	Sonesta Medical AB	2
LF	Liebel-Flarsheim Company LLC	2
Urology C Arm Table	Biodex Medical Systems, Inc.	2
Brachytherapy Table	Biodex Medical Systems, Inc.	2
ZS-100IR	Shimadzu Corp.	2
YSF-300	Shimadzu Corp.	2

Showing 12 of 22. All products under Table, Radiographic, Tilting

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K935444	1994-09-02

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.