510(k) · Cleared
ClearedRetina Camera TRC-NW7SF Mark II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topcon Corp. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Jun 30, 2009 as substantially equivalent to K946058 (Canon USA, Inc., 1995) and 2 other predicates after a 160-day review. Its family tree reaches back 4 generations to 1995. 30 later devices descend from it.
- Decided
- Jun 30, 2009
- Review
- 160 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K941234 (1995). 8 ancestors in all, the oldest K946058 (1995). 30 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 3 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 2 generations backK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- 1 generation backK041367 Topcon Model TRC-NW200 Non-Mydriatic Retinal CameraTopcon Corp. · 2004
- This deviceK090115 Retina Camera TRC-NW7SF Mark IITopcon Corp. · 2009
- Descendant · cites it directly · 28 of its ownK100207 Non-Mydriatic Retinal Camera, Model TRC-NW8FTopcon Corp. · 2010
- Descendant · 2 generations on · 13 of its ownK112184 Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012
- Descendant · 2 generations on · 11 of its ownK123460 TRC-NW300 Non-Mydriatic Retinal CameraTopcon Medical Systems, Inc. · 2013
- Descendant · 3 generations on · 8 of its ownK161509 3D OCT-1 MaestroTopcon Corporation · 2016
- Descendant · 4 generations on · 5 of its ownK170164 3D OCT-1 MaestroTopcon Corporation · 2017
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K100207Non-Mydriatic Retinal Camera, Model TRC-NW8FTopcon Corp. · 2010 · cites it directly28descendants
- K112184Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012 · 2 generations on13descendants
- K123460TRC-NW300 Non-Mydriatic Retinal CameraTopcon Medical Systems, Inc. · 2013 · 2 generations on11descendants
- K1615093D OCT-1 MaestroTopcon Corporation · 2016 · 3 generations on8descendants
- K1701643D OCT-1 MaestroTopcon Corporation · 2017 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −3 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −2 | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| −1 | K041367 | Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera | Topcon Corp. | 2004 | — |
| 0 (this device) | K090115 | Retina Camera TRC-NW7SF Mark II | Topcon Corp. | 2009 | — |
| +1 | K100207 | Non-Mydriatic Retinal Camera, Model TRC-NW8F | Topcon Corp. | 2010 | — |
| +2 | K112184 | Cirrus Photo | Carl Zeiss Meditec, Inc. | 2012 | — |
| +2 | K123460 | TRC-NW300 Non-Mydriatic Retinal Camera | Topcon Medical Systems, Inc. | 2013 | — |
| +3 | K161509 | 3D OCT-1 Maestro | Topcon Corporation | 2016 | — |
| +4 | K170164 | 3D OCT-1 Maestro | Topcon Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2026 | 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 HKI? 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 HKI device
- #1 K253176 TearViewscore 12.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K946058 | 60 Fundus Camera CF-60UVSummary page 3…age 17 of 81 Basis of Substantial Equivalence The TOPCON Retinal Camera TRC-NW7SF MARK II is as safe and effective as Canon Inc. Fundus Camera CF-60UVi (K946058), TOPCON CORPORATION Non-Mydriatic Retinal Camera TRC-NW200 (K041367) and Kowa Company, Ltd. KOWA VX-10 (K043213).… | 1995 |
| * | K041367 | Topcon Model TRC-NW200 Non-Mydriatic Retinal CameraSummary page 3…amera TRC-NW7SF MARK II is as safe and effective as Canon Inc. Fundus Camera CF-60UVi (K946058), TOPCON CORPORATION Non-Mydriatic Retinal Camera TRC-NW200 (K041367) and Kowa Company, Ltd. KOWA VX-10 (K043213). The TOPCON Retinal Camera TRC-NW7SF MARK II and the predicated devices… | 2004 |
| * | K043213 | Kowa VX-10Summary page 3…Canon Inc. Fundus Camera CF-60UVi (K946058), TOPCON CORPORATION Non-Mydriatic Retinal Camera TRC-NW200 (K041367) and Kowa Company, Ltd. KOWA VX-10 (K043213). The TOPCON Retinal Camera TRC-NW7SF MARK II and the predicated devices have the same intended use and similar indications… | 2005 |
What descends from it? (30)
See all 302 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K100207 (Topcon Corp., 2010) has gone furthest, with 28 descendants of its own.
- 1 other device also cites its predicate K946058.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · HKI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HKI
167in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HKI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HKI
1in 2023
MAUDE reports naming product code HKI, 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 | 2 | — | 0 | 3 |
| 2008 | 5 | 29 | 0 | 1 |
| 2009 | 11 | 104 | 0 | 1 |
| 2010 | 6 | 140 | 0 | 0 |
| 2011 | 7 | 160 | 0 | 0 |
| 2012 | 5 | 179 | 1 | 2 |
| 2013 | 7 | 141 | 0 | 22 |
| 2014 | 4 | 135 | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 4 | 146 | 1 | 66 |
| 2017 | 2 | — | 1 | 20 |
| 2018 | 6 | 71 | 1 | 14 |
| 2019 | 4 | 73 | 0 | 0 |
| 2020 | 5 | 182 | 0 | 5 |
| 2021 | 4 | 155 | 0 | 3 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 5 | 259 | 0 | 1 |
| 2024 | 3 | 28 | 0 | 0 |
| 2025 | 4 | 167 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Retina Camera TRC-NW7SF MARK II system is intended for use in capturing images of the retina and the anterior segment of the eye and presenting the data to the eye care professional,
with or without the use of mydriatic.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090115 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090115: Retina Camera TRC-NW7SF Mark II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090115
Report an extraction error
Are you the manufacturer?
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