(15 days)
The LifeJet™ Video Link is a video image digitizer for the acquisition and conversion into digital format of medical images codified as analogue video signal.
The LifeJet™ Video Link has been developed to be used together with LifeJet™ Printers to produce referral prints of images coming out from ultrasound systems or other medical equipment through the video signal output.
The LifeJet™ Video Link is a small box that integrates the functions and the hardware of a standard personal computer based on a Pentium architecture, for the purpose of acquisition and conversion into digital format of medical images codified as analogue video signal.
The provided text, K013395 for Ferrania S.p.A. LifeJet™ Video Link, does not contain information about acceptance criteria or a study proving the device meets said criteria.
The document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to a predicate device, not on presenting performance data from a specific study against predefined acceptance criteria.
Specifically, Section 10.9, titled "Performance data," explicitly states: "Not required for this type of device and its level of concern."
Therefore, I cannot fulfill your request for the detailed information as it is not present in the provided input.
§ 892.2030 Medical image digitizer.
(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). 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.