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Product Classification

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Device

system, x-ray, fluoroscopic, image-intensified

Regulation Medical Specialty

Radiology

Review Panel

Radiology

Product Code

JAA

Premarket Review

Office of Radiological Health (OHT8)
Division of Imaging Devices and Electronic Products (DHT8B)

Submission Type

510(k)

Regulation Number

892.1650

Device Class

2

Total Product Life Cycle (TPLC)

TPLC Product Code Report

GMP Exempt?

No

Summary Malfunction
Reporting

Eligible

Implanted Device?

No

Life-Sustain/Support Device?

No

Recognized Consensus Standards

12-230 NEMA XR 24-2008 (R2014)
Primary user controls for interventional angiography x-ray equipment
12-286 NEMA XR 27 Amendment 1-2013
X-ray equipment for interventional procedures - User Quality Control Mode
12-290 IEC 61910-1 Edition 1.0 2014-09
Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
12-317 IEC 60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
12-329 IEC 60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION
Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
12-348 IEC 60601-2-54 Edition 2.0 2022-09
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
12-351 IEC 60601-2-43 Edition 3.0 2022-12
Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures

Third Party Review

Eligible for 510(k) Third Party Review Program

Accredited Persons

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