AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO

• K Number: K000159
• Device Name: AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO
• Manufacturer: AGFA CORP.
• Date Cleared: 2000-02-16 ( 28 days)
• Product Code: IXK
• Regulation Number: 892.1630

Intended Use

Get notified when PDF is available

Device Description

Get notified when PDF is available

Predicate Devices

N/A

Reference Devices

N/A

AI/ML (Artificial Intelligence / Machine Learning)

N/A

Therapeutic

N/A

Diagnostic

N/A

SaMD (Software as a Medical Device)

N/A

IVD (In Vitro Diagnostic)

N/A

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

N/A

Regulation Number and Section

§ 892.1630 Electrostatic x-ray imaging system.

(a)
Identification. An electrostatic x-ray imaging system is a device intended for medical purposes that uses an electrostatic field across a semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x-radiation into an electrostatic image and, subsequently, into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

N/A