510(k) · Cleared
ClearedHuvitz Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huvitz Co., Ltd. · NFJ System, Image Management, Ophthalmic
Cleared on Jul 18, 2019 as substantially equivalent to K161829 (Huvitz Co., Ltd., 2017) after a 30-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Jul 18, 2019
- Review
- 30 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K896095 (1990). 12 ancestors in all, the oldest K870039 (1987). No later device cites it as a predicate yet.
- Root · 8 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 7 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 6 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 5 generations backK012093 Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001
- 4 generations backK013694 Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002
- 3 generations backK082364 Imagenet Professional PC Software System or Imagenet Professional…Topcon Corp. · 2008
- 2 generations backK142423 EyeSuite ImagingHaag-Streit AG · 2014 · Recalled
- 1 generation backK161829 Huvitz Imaging SystemHuvitz Co., Ltd. · 2017
- This deviceK191615 Huvitz Imaging SystemHuvitz Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −7 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −6 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −5 | K012093 | Aetmed Image Processing Software | Aetmed, S.P.A. | 2001 | — |
| −4 | K013694 | Nidek Advanced Vision Information System (Navis) | Nidek, Inc. | 2002 | — |
| −3 | K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet… | Topcon Corp. | 2008 | — |
| −2 | K142423 | EyeSuite Imaging | Haag-Streit AG | 2014 | 1 |
| −1 | K161829 | Huvitz Imaging System | Huvitz Co., Ltd. | 2017 | — |
| 0 (this device) | K191615 | Huvitz Imaging System | Huvitz Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K161829 | Huvitz Imaging SystemSummary page 4…Picture archiving and communications system Regulatory Class:: Class II Product Code: NFJ Predicate Device: Huvitz Imaging System (HIS-5000U), K161829 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class::… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 29 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 12 ancestors has a recall of any class.
How does its category compare?
All NFJ devicesNFJ System, Image Management, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Huvitz Imaging system (HIS-5000U) is intended for controlling digital imaging devices and for acceptance, transfer, display, storage and digital processing of documentation ophthalmic images and videos, acquired from a slit lamp camera through a direct connection to a PC or to multiple PCs via a local network.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191615: Huvitz Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191615
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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