Last synced on 20 December 2024 at 11:05 pm

System, X-Ray, Fluoroscopic, Non-Image-Intensified

Page Type
Product Code
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.1660
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 892.1660 Non-image-intensified fluoroscopic x-ray system

§ 892.1660 Non-image-intensified fluoroscopic x-ray system.

(a) Identification. A non-image-intensified fluoroscopic x-ray system is a device intended to be used to visualize anatomical structures by using a fluorescent screen to convert a pattern of x-radiation 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.

System, X-Ray, Fluoroscopic, Non-Image-Intensified

Page Type
Product Code
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.1660
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 892.1660 Non-image-intensified fluoroscopic x-ray system

§ 892.1660 Non-image-intensified fluoroscopic x-ray system.

(a) Identification. A non-image-intensified fluoroscopic x-ray system is a device intended to be used to visualize anatomical structures by using a fluorescent screen to convert a pattern of x-radiation 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.