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Solid State Fluoroscopic X-Ray Imager

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 contained within a plastic or metal housing and typically flat and rectangular. May be connected to other components of a fluoroscopic x-ray system through wired or wireless means.
Technical Method
Uses a indirect-conversion (x-ray scintillator based) or direct-conversion (x-ray photoconductor based) methods to convert fluoroscopic x-ray patterns into electric signals.
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)
Device Classification
Class 2
Regulation Number
892.1650
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.1650 Image-intensified fluoroscopic x-ray system

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a) Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 57369, Nov. 15, 2001; 84 FR 71818, Dec. 30, 2019]

Solid State Fluoroscopic X-Ray Imager

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 contained within a plastic or metal housing and typically flat and rectangular. May be connected to other components of a fluoroscopic x-ray system through wired or wireless means.
Technical Method
Uses a indirect-conversion (x-ray scintillator based) or direct-conversion (x-ray photoconductor based) methods to convert fluoroscopic x-ray patterns into electric signals.
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)
Device Classification
Class 2
Regulation Number
892.1650
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.1650 Image-intensified fluoroscopic x-ray system

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a) Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 57369, Nov. 15, 2001; 84 FR 71818, Dec. 30, 2019]