(53 days)
VivoSight is a Multi-Beam Optical Coherence Tomography (OCT) system indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body.
Multi-Beam Optical Coherence Tomography (OCT) tissue imaging system
The provided text does not contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. The document is a 510(k) premarket notification summary and an FDA clearance letter for the "VivoSight Topical OCT System".
It primarily discusses:
- Device Identification: Trade Name, Common Name, Classification, Predicate Device.
- Intended Use: "Intended to be used as an imaging tool in the evaluation of external human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization."
- FDA Clearance: Confirmation of substantial equivalence to a legally marketed predicate device.
Therefore, I cannot provide the requested table and study details based on the input.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.