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510(k) Data Aggregation
(114 days)
IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP
The IP system is used by health professionals to capture, store, encode, encrypt, transmit, decrypt, decode, display, process, spatially calibrate, assess, grade and report on images and data that are captured on a range of approved medical devices that include but are not limited to :
- A. Mydriatic Fundus Cameras
- B. Non Mydriatic Fundus Cameras
- C. Scanning Laser Ophthalmoscopes
- D. Optical Coherence Tomography Instruments
- E. Bio Microscopes (Slit Lamps)
- F. Non Radiometric Ultrasound devices
- G. Video image sources
- H. TWAIN compliant imaging sources
- I. Compliant data sources placed in network accessible folders and directories
- Images of known format from digital cameras and scanners J.
- K. Electronic information complying to accepted DICOM formats
- L. Other devices connected in proprietary formats
Not Found
This document primarily outlines the FDA's 510(k) clearance for the Digital Healthcare iP System, acting as a cover letter and an "Indications for Use" statement. It does not contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot provide the requested information from the provided text. The document focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study.
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