510(k) · Cleared
ClearedI-SCAN
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ophthalmic Technologies, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on May 13, 1996 after a 90-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- May 13, 1996
- Review
- 90 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK960622 I-SCANOphthalmic Technologies, Inc. · 1996
- Descendant · cites it directly · 3 of its ownK030770 Oti Scan with TransducersOphthalmic Technologies, Inc. · 2003
- Descendant · 2 generations on · 2 of its ownK031391 HF Module with TransducersOphthalmic Technologies, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK092837 Oti-Scan 3000Opko Instrumentation, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK103471 Ubm PlusAccutome, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK024114 A-SCAN 100Ophthalmic Technologies, Inc. · 2003
Most influential descendants
Showing 5 of 5 · See all- K030770Oti Scan with TransducersOphthalmic Technologies, Inc. · 2003 · cites it directly3descendants
- K031391HF Module with TransducersOphthalmic Technologies, Inc. · 2003 · 2 generations on2descendants
- K092837Oti-Scan 3000Opko Instrumentation, Inc. · 2009 · cites it directly1descendant
- K103471Ubm PlusAccutome, Inc. · 2011 · 2 generations on0descendants
- K024114A-SCAN 100Ophthalmic Technologies, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960622 | I-SCAN | Ophthalmic Technologies, Inc. | 1996 | — |
| +1 | K030770 | Oti Scan with Transducers | Ophthalmic Technologies, Inc. | 2003 | — |
| +2 | K031391 | HF Module with Transducers | Ophthalmic Technologies, Inc. | 2003 | — |
| +1 | K092837 | Oti-Scan 3000 | Opko Instrumentation, Inc. | 2009 | — |
| +2 | K103471 | Ubm Plus | Accutome, Inc. | 2011 | — |
| +1 | K024114 | A-SCAN 100 | Ophthalmic Technologies, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | Sonomed Model A2500 ultrasound system Named without a submission number | |
| * | — | Biophysic Ophthascan B system Named without a submission number |
What descends from it? (5)
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?
- Of its descendants, K030770 (Ophthalmic Technologies, Inc., 2003) has gone furthest, with 3 descendants of its own.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The OTI 1i+tech “i-scan” ultrasound system is intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL power.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960622 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960622: I-SCAN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960622
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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