Last synced on 19 July 2024 at 11:05 pm

X-Ray Field Indicator Light (Laser)

Page Type
Product Code
Definition
A laser incorporated in a diagnostic x-ray system that is irradiated onto the film screen area indicating the x-radiation area. The beam is usually scanned to show a rectangular region for patient placement.
Physical State
Laser light
Technical Method
A laser incorporated in a diagnostic x-ray system that is irradiated onto the film screen area indicating the x-radiation area. The beam is usually scanned to show a rectangular region for patient placement.
Target Area
Body
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
892.5780
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.5780 Light beam patient position indicator

§ 892.5780 Light beam patient position indicator.

(a) Identification. A light beam patient position indicator is a device that projects a beam of light (incoherent light or laser) to determine the alignment of the patient with a radiation beam. The beam of light is intended to be used during radiologic procedures to ensure proper positioning of the patient and to monitor alignment of the radiation beam with the patient's anatomy.

(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 the limitations in § 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, 2001]

X-Ray Field Indicator Light (Laser)

Page Type
Product Code
Definition
A laser incorporated in a diagnostic x-ray system that is irradiated onto the film screen area indicating the x-radiation area. The beam is usually scanned to show a rectangular region for patient placement.
Physical State
Laser light
Technical Method
A laser incorporated in a diagnostic x-ray system that is irradiated onto the film screen area indicating the x-radiation area. The beam is usually scanned to show a rectangular region for patient placement.
Target Area
Body
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
892.5780
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.5780 Light beam patient position indicator

§ 892.5780 Light beam patient position indicator.

(a) Identification. A light beam patient position indicator is a device that projects a beam of light (incoherent light or laser) to determine the alignment of the patient with a radiation beam. The beam of light is intended to be used during radiologic procedures to ensure proper positioning of the patient and to monitor alignment of the radiation beam with the patient's anatomy.

(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 the limitations in § 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, 2001]