Who else makes this device?

Name: Urology C Arm Table
Brand: Urology C Arm Table

Urology C Arm Table · Table, Radiographic, Tilting → Radiology

2manufacturers in China registered for this device type

2catalogue numbers in this listing

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 Urology C Arm Table
Listed by	Biodex Medical Systems, Inc., United States
FDA product code	IXR
Device type	Table, Radiographic, Tilting
Device class	Class 2
Regulation	21 CFR 892.1980
Premarket notification	Exempt
Record published	2017-12-18
Record revised	2023-07-25 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number
Distribution end date	2023-07-24

Catalogue Numbers

Catalogue numbers for Urology C Arm Table
Catalogue number	Size	Status
058-805		Withdrawn
058-800		Withdrawn

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
Brachytherapy Table	Biodex Medical Systems, Inc.	2
ZS-100IR	Shimadzu Corp.	2
YSF-300	Shimadzu Corp.	2
Sonesta F3	Sonesta Medical AB	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
K950981	1995-04-03

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.

Urology C Arm Table