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Fluoroscopic X-Ray Image Intensifier

Page Type
Product Code
Definition
To instantaneously convert an x-ray pattern from a fluoroscopic x-ray system into a corresponding light image of higher energy density.
Physical State
Typically encased in a metal housing containing a low absorbency/scatter input window, typically aluminum, input fluorescent screen, photocathode, electron optics, output fluorescent screen and output window
Technical Method
Uses fluorescent screens, photocathodes, and electron lenses to convert input x-rays into visible images of sufficient brightness.
Target Area
May be used to image any part of the body which is/may be in motion.
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
892.1960
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.1960 Radiographic intensifying screen

§ 892.1960 Radiographic intensifying screen.

(a) Identification. A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that transforms incident x-ray photons into visible light and intended for medical purposes to expose radiographic film.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 65 FR 2323, Jan. 14, 2000]

Fluoroscopic X-Ray Image Intensifier

Page Type
Product Code
Definition
To instantaneously convert an x-ray pattern from a fluoroscopic x-ray system into a corresponding light image of higher energy density.
Physical State
Typically encased in a metal housing containing a low absorbency/scatter input window, typically aluminum, input fluorescent screen, photocathode, electron optics, output fluorescent screen and output window
Technical Method
Uses fluorescent screens, photocathodes, and electron lenses to convert input x-rays into visible images of sufficient brightness.
Target Area
May be used to image any part of the body which is/may be in motion.
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
892.1960
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.1960 Radiographic intensifying screen

§ 892.1960 Radiographic intensifying screen.

(a) Identification. A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that transforms incident x-ray photons into visible light and intended for medical purposes to expose radiographic film.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 65 FR 2323, Jan. 14, 2000]