510(k) · Cleared
ClearedOti Scan with Transducers
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 Mar 27, 2003 as substantially equivalent to K960622 (Ophthalmic Technologies, Inc., 1996) after a 16-day review. Its family tree reaches back 1 generation to 1996. 3 later devices descend from it.
- Decided
- Mar 27, 2003
- Review
- 16 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960622 (1996). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK960622 I-SCANOphthalmic Technologies, Inc. · 1996
- This deviceK030770 Oti Scan with TransducersOphthalmic Technologies, Inc. · 2003
- Descendant · cites it directly · 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
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960622 | I-SCAN | Ophthalmic Technologies, Inc. | 1996 | — |
| 0 (this device) | K030770 | Oti Scan with Transducers | Ophthalmic Technologies, Inc. | 2003 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 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? (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 |
|---|---|---|---|
| * | K960622 | I-SCANSummary page 1…cation name: System, Imaging, Ultrasonic, Ophthalmic, 980IYO Diagnostic Ultrasound Transducer, 90-ITX (3) Equivalent legally-marketed devices OTI i-scan, K960622 (4) Description OTI-Scan Page A 3 The OTI-scan is a compact Ultras… | 1996 |
What descends from it? (3)
2 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?
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-scan ultrasound system is a multi-purpose personal-computer-based ultrasonic diagnosis system for ophthalmic applications, 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.
Transducer for B-scans with OTI-Scan Ophthalmic system
Biometric and diagnostic A-scans with OTI-scan ophthalmic system
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030770 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030770: Oti Scan with Transducers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030770
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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