510(k) · Cleared
ClearedIP System, Oculab IP, Optomize IP, Retasure IP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Digital Healthcare, Ltd. · NFJ System, Image Management, Ophthalmic
Cleared on Aug 31, 2007 after a 114-day review. The FDA summary names no predicate by number. 31 later devices descend from it.
- Decided
- Aug 31, 2007
- Review
- 114 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 2 citing it directly.
- This deviceK071299 IP System, Oculab IP, Optomize IP, Retasure IPDigital Healthcare, Ltd. · 2007
- Descendant · cites it directly · 29 of its ownK093313 SynergyTopcon Medical Systems, Inc. · 2009
- Descendant · 2 generations on · 25 of its ownK122938 Forum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG · 2012 · Recalled
- Descendant · 2 generations on · 9 of its ownK132667 Synergy OdmTopcon Medical Systems, Inc. · 2013
- Descendant · 3 generations on · 8 of its ownK151952 Synergy ODMTopcon Medical Systems, Inc. · 2015
- Descendant · 4 generations on · 4 of its ownK182376 HarmonyTopcon Medical Systems, Inc. · 2018
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K093313SynergyTopcon Medical Systems, Inc. · 2009 · cites it directly29descendants
- K122938Forum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG · 2012 · 2 generations on25descendants
- K132667Synergy OdmTopcon Medical Systems, Inc. · 2013 · 2 generations on9descendants
- K151952Synergy ODMTopcon Medical Systems, Inc. · 2015 · 3 generations on8descendants
- K182376HarmonyTopcon Medical Systems, Inc. · 2018 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071299 | IP System, Oculab IP, Optomize IP, Retasure IP | Digital Healthcare, Ltd. | 2007 | — |
| +1 | K093313 | Synergy | Topcon Medical Systems, Inc. | 2009 | — |
| +2 | K122938 | Forum Forum Archive Forum Archive & Viewer Forum Assist Match | Carl Zeiss Meditec, AG | 2012 | 1 |
| +2 | K132667 | Synergy Odm | Topcon Medical Systems, Inc. | 2013 | — |
| +3 | K151952 | Synergy ODM | Topcon Medical Systems, Inc. | 2015 | — |
| +4 | K182376 | Harmony | Topcon Medical Systems, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NFJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NFJ device
- #1 K260694 Zeiss Clinic 360score 15.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (31)
See all 312 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K093313 (Topcon Medical Systems, Inc., 2009) has gone furthest, with 29 descendants of its own.
How does its category compare?
All NFJ devicesNFJ System, Image Management, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NFJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NFJ
85in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NFJ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NFJ
2in 2022
MAUDE reports naming product code NFJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 4 | 67 | 0 | 0 |
| 2010 | 0 | — | 2 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 5 | 73 | 0 | 6 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 3 | 87 | 1 | 2 |
| 2016 | 0 | — | 0 | 29 |
| 2017 | 5 | 175 | 0 | 4 |
| 2018 | 7 | 84 | 0 | 0 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 5 | 116 | 2 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 3 | 284 | 1 | 2 |
| 2023 | 4 | 85 | 0 | 0 |
| 2024 | 2 | — | 1 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.…
Read the full statement (118 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071299 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071299: IP System, Oculab IP, Optomize IP, Retasure IP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071299
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026