Who else makes this device?

Name: CuattroDR
Brand: CuattroDR

CuattroDR · System, X-Ray, Stationary → Radiology

7manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Shanghai (3), Beijing (2), Jiangsu (1).

Chinese manufacturers registered for FDA product code KPR
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
Shanghai United Imaging Healthcare Co., Ltd.	Shanghai	Shanghai	Manufacturer	12
Siemens Shanghai, Medical Equipment Ltd.	Shanghai	Shanghai	Contract manufacturer	10
Carestream Health, Inc., Global R&D Center	Shanghai	Shanghai	Specification developer	8
Philips Healthcare (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	5
Orich Medical Equipment (Tianjin) Co., Ltd.	Tianjin	Tianjin	Manufacturer	5

Record

Regulatory record for CuattroDR
Listed by	Cuattro, LLC, United States
FDA product code	KPR
Device type	System, X-Ray, Stationary
Device class	Class 2
Regulation	21 CFR 892.1680
510(k)	K161937
Record published	2017-05-26
Record revised	2025-03-24 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for CuattroDR
Catalogue number	Size	Status
SWR-00069-MD		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Drgem	Drgem Corporation	171
Q-RAD System	Carestream Health, Inc.	159
DRX – Ascend System	Carestream Health, Inc.	121
FDR Clinica	Drgem Corporation	41
RADspeed Pro	Shimadzu Corp.	31
FDR Visionary Suite	Shimadzu Corp.	17
Exsys DEXi	Drtech Corporation	15
Del Medical, Inc.	DEL Medical, Inc.	15
GXR-Es,ecs Diagnostic X-ray System	Drgem Corporation	14
X-CEL X-RAY Corporation	Arquilla, Inc.	14
DRX-Evolution Plus System	Carestream Health, Inc.	12
Carestream DRX-Evolution	Carestream Health, Inc.	10

Showing 12 of 138. All products under System, X-Ray, Stationary

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K161937	2016-10-06

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of CuattroDR
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Cuattro Imaging, LLC	510(k) number	2019-10-15	Class II	Device Design	There is a potential that an image from a previous patient study to show up in a later patient study. This may result in misdiagnosis of the correct patient.	9 units	2021-04-27

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.

CuattroDR