(89 days)
SIAscope is a non-invasive skin analysis system, which provides a synthesized 'image' showing the relative location of blood collagen and pigment.
SIAscope is a non-invasive skin analysis system.
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a device called SIAscope II. The letter primarily addresses the substantial equivalence determination and regulatory compliance. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request based on the given input.
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.