Prorad 3NC

The PRORAD 3NC Ceiling suspended system is very versatile and robust with light weight design. The ceiling suspension consists of ceiling rail system with longitudinal travel (300 cm) and…

Registry build 21.09.26

The PRORAD 3NC Ceiling suspended system is very versatile and robust with light weight design. The ceiling suspension consists of ceiling rail system with longitudinal travel (300 cm) and transversal travel (200 cm). The telescopic column travels a vertical distance (160 cm). The longitudinal, transverse and vertical travel is automatic. All the braking mechanism of the ceiling suspension is Electromagnetic. The ceiling suspension has wide range of rotation around the horizontal and vertical axis. The system is powered by a three phase X-Ray generator designed to carry out high precision radiological exposures that can be used in an easy way with high reliability. It is fully integrated with Flat panel detector System and components such as the Vertical Bucky and X-Ray tubes such that the productivity of the department is at its best. The ceiling suspended system further offers configurations based on the Hospital and radiologists’ need → Manual/Auto tracking / Full Auto; Single / Dual detector; Wired / Wireless Detector; precisely every “choice and convenience” a Radiologist and Technologist can demand from an imaging equipment. The four-way floating tabletop movement and adjustable table height is ideally suited for a dual detector system and makes it comfortable for a Radiographer to work on a physically limited patient.

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 Prorad 3NC
Listed by Prognosys Medical Systems Private Limited, India
FDA product code KPR
Device type System, X-Ray, Stationary
Device class Class 2
Regulation 21 CFR 892.1680
Establishment Manufacturer
510(k) K183541
Record published 2026-05-07

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Label carries manufacturing date, serial number
Storage Handling environment temperature 10 to 40 °C; Storage environment temperature -20 to 60 °C; Handling environment humidity 30 to 75 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment atmospheric pressure 50 to 106 KiloPascal

Catalogue Numbers

Catalogue numbers for Prorad 3NC
Catalogue number Size Status
A90-3NC-0001 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
K183541 2019-01-24

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer