510(k) · Cleared
ClearedDigital Eye-Fundus Camera
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medimaging Integrated Solutions, Inc. (Miis) · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Sep 28, 2012 as substantially equivalent to K110986 (Optomed OY, 2011) after a 179-day review. Its family tree reaches back 3 generations to 2001. 6 later devices descend from it.
- Decided
- Sep 28, 2012
- Review
- 179 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003376 (2001). 4 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK003376 Welch Allyn 11800 OpthalmoscopeWelch Allyn, Inc. · 2001
- 2 generations backK092056 Optomed Smartscope, Model M3-1 EY1Optomed OY · 2009
- 1 generation backK110986 Optomed Smartscope M5 EY3 and M5 ES1Optomed OY · 2011
- This deviceK120982 Digital Eye-Fundus CameraMedimaging Integrated Solutions, Inc. (Miis) · 2012
- Descendant · cites it directly · 2 of its ownK180306 NexyNext Sight Srl · 2018
- Descendant · cites it directly · 1 of its ownK170470 Digital Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis) · 2017
- Descendant · 2 generations on · 0 of its ownK250683 Resolve Fundus CameraOptain Health, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK202221 VX650Luneau Technology Operations · 2021
- Descendant · 2 generations on · 0 of its ownK193188 MiiS Horus Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis) · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K180306NexyNext Sight Srl · 2018 · cites it directly2descendants
- K170470Digital Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis) · 2017 · cites it directly1descendant
- K250683Resolve Fundus CameraOptain Health, Inc. · 2025 · 2 generations on0descendants
- K202221VX650Luneau Technology Operations · 2021 · 2 generations on0descendants
- K193188MiiS Horus Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis) · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003376 | Welch Allyn 11800 Opthalmoscope | Welch Allyn, Inc. | 2001 | — |
| −2 | K092056 | Optomed Smartscope, Model M3-1 EY1 | Optomed OY | 2009 | — |
| −1 | K110986 | Optomed Smartscope M5 EY3 and M5 ES1 | Optomed OY | 2011 | — |
| 0 (this device) | K120982 | Digital Eye-Fundus Camera | Medimaging Integrated Solutions, Inc. (Miis) | 2012 | — |
| +1 | K180306 | Nexy | Next Sight Srl | 2018 | — |
| +1 | K170470 | Digital Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | 2017 | — |
| +2 | K250683 | Resolve Fundus Camera | Optain Health, Inc. | 2025 | — |
| +2 | K202221 | VX650 | Luneau Technology Operations | 2021 | — |
| +2 | K193188 | MiiS Horus Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K110986 | Optomed Smartscope M5 EY3 and M5 ES1 | 2011 |
What descends from it? (6)
3 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 11 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K180306 (Next Sight Srl, 2018) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K110986.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
MiiS Horns Scope DEC 100 is a digital hand-held eye-fimndus camera used to record digital photographs and video of the frndus of the human eye and surrounding area.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120982 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120982: Digital Eye-Fundus Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120982
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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