# K071299: IP System, Oculab IP, Optomize IP, Retasure IP

- Pathway: 510(k) (Traditional)
- Applicant: Digital Healthcare, Ltd.
- Decided: Aug 31, 2007 after 114 days
- Product code: NFJ (System, Image Management, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
31 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K093313: Synergy (2009), 29 descendants of its own
- K122938: Forum Forum Archive Forum Archive & Viewer Forum Assist Match (2012), 25 descendants of its own
- K132667: Synergy Odm (2013), 9 descendants of its own
- K151952: Synergy ODM (2015), 8 descendants of its own
- K182376: Harmony (2018), 4 descendants of its own

## Indications for use
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 J. Images of known format from digital cameras and scanners K. Electronic information complying to accepted DICOM formats L. Other devices connected in proprietary formats

Source page: https://510kreport.com/device/K071299
Methodology: https://510kreport.com/methodology