510(k) · Cleared
ClearedI3 System-Abd Diagnostic Ultrasound
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ellex, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Dec 27, 2010 as substantially equivalent to K083061 (Ellex, Inc., 2009) after an 18-day review. Its family tree reaches back 1 generation to 2009.
- Decided
- Dec 27, 2010
- Review
- 18 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K083061 (2009). No later device cites it as a predicate yet.
- Root · 1 generation backK083061 Ellex Innovative Imaging Eye Cubed V4Ellex, Inc. · 2009
- This deviceK103608 I3 System-Abd Diagnostic UltrasoundEllex, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K083061 | Ellex Innovative Imaging Eye Cubed V4 | Ellex, Inc. | 2009 | — |
| 0 (this device) | K103608 | I3 System-Abd Diagnostic Ultrasound | Ellex, Inc. | 2010 | — |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 |
|---|---|---|---|
| * | K083061 | Ellex Innovative Imaging Eye Cubed V4Summary page 5…nt B-scan transducer a 27 200 Intended Use Posterior 10 MHz B-scan imaging of the eye 510(k) Number K083061, K ,03So Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:… | 2009 |
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?
- Its one ancestor has no recall.
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. 2010, this device’s year, is highlighted.
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 Eye Cubed V4 is indicated for use in ophthalmic imaging when the following conditions are present or suspected:
Cataracts
Retinal Detachments (a separation of the retina from the middle coat of the eyeball)
Orbital Lesions
Tumors.
Foreign bodies
Inflammation
Vascular Irregularities
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K103608 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103608: I3 System-Abd Diagnostic Ultrasound.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103608
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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