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Dosimeter, Ionizing Radiation, Implanted

Page Type
Product Code
Definition
Verify radiation dose to organs from external radiation therapy.
Physical State
glass encapsulated electronics
Technical Method
Radiation causes change in MOSFET diode that is perportional to dose which can be interigated by external reader.
Target Area
Radiation therapy target organ
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.5050
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.5050 Medical charged-particle radiation therapy system

§ 892.5050 Medical charged-particle radiation therapy system.

(a) Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

(b) Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, 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 64 FR 1125, Jan. 8, 1999]

Dosimeter, Ionizing Radiation, Implanted

Page Type
Product Code
Definition
Verify radiation dose to organs from external radiation therapy.
Physical State
glass encapsulated electronics
Technical Method
Radiation causes change in MOSFET diode that is perportional to dose which can be interigated by external reader.
Target Area
Radiation therapy target organ
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.5050
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.5050 Medical charged-particle radiation therapy system

§ 892.5050 Medical charged-particle radiation therapy system.

(a) Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

(b) Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, 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 64 FR 1125, Jan. 8, 1999]