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Scanner, Fluorescent

Page Type
Product Code
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.1220
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 892.1220 Fluorescent scanner

§ 892.1220 Fluorescent scanner.

(a) Identification. A fluorescent scanner is a device intended to measure the induced fluorescent radiation in the body by exposing the body to certain x-rays or low-energy gamma rays. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts and accessories.

(b) Classification. Class II.