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Camera, Ophthalmic, Slit-Scanning

Page Type
Product Code
Definition
An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
Physical State
Slit-scanning cameras consist of an incoherent light source, image forming lens, slit forming optics, scanner, an image sensor, and image reconstruction software.
Technical Method
The imaging plane is scanned by a rectangular slit of non-coherent light and reflected images of the illuminated areas are sequentially captured by an imaging sensor. An ophthalmic image is reconstructed from individual slit images in software.
Target Area
Eye and ocular tissues (anterior and posterior segment).
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.1120
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 886.1120 Ophthalmic camera

§ 886.1120 Ophthalmic camera.

(a) Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

(b) Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

[55 FR 48441, Nov. 20, 1990, as amended at 84 FR 71817, Dec. 30, 2019]

Camera, Ophthalmic, Slit-Scanning

Page Type
Product Code
Definition
An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
Physical State
Slit-scanning cameras consist of an incoherent light source, image forming lens, slit forming optics, scanner, an image sensor, and image reconstruction software.
Technical Method
The imaging plane is scanned by a rectangular slit of non-coherent light and reflected images of the illuminated areas are sequentially captured by an imaging sensor. An ophthalmic image is reconstructed from individual slit images in software.
Target Area
Eye and ocular tissues (anterior and posterior segment).
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.1120
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 886.1120 Ophthalmic camera

§ 886.1120 Ophthalmic camera.

(a) Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

(b) Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

[55 FR 48441, Nov. 20, 1990, as amended at 84 FR 71817, Dec. 30, 2019]