510(k) · Cleared
ClearedAviso Ophthalmic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantel Medical · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Aug 3, 2005 as substantially equivalent to K021683 (Quantel Medical, 2002) after a 26-day review. Its family tree reaches back 2 generations to 1993. 6 later devices descend from it.
- Decided
- Aug 3, 2005
- Review
- 26 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K926251 (1993). 3 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK926251 B-Scan Opthalmic Ultrasound Imaging SystemBiovision, Inc. · 1993
- 1 generation backK021683 Cinescan SQuantel Medical · 2002
- This deviceK051851 Aviso Ophthalmic Ultrasound SystemQuantel Medical · 2005
- Descendant · cites it directly · 3 of its ownK094038 Compact TouchQuantel S.A. · 2010
- Descendant · 2 generations on · 1 of its ownK180265 COMPACT TOUCH Ophthalmic Ultrasound SystemQuantel Medical · 2018
- Descendant · 3 generations on · 0 of its ownK213254 Axialis Ophthalmic Ultrasound SystemQuantel Medical · 2021
- Descendant · cites it directly · 0 of its ownK183414 AbsoluQuantel Medical · 2019
- Descendant · cites it directly · 0 of its ownK152318 MD-2300S Ultrasonic A/B Scanner for OphthalmologyMEDA Co., Ltd. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K094038Compact TouchQuantel S.A. · 2010 · cites it directly3descendants
- K180265COMPACT TOUCH Ophthalmic Ultrasound SystemQuantel Medical · 2018 · 2 generations on1descendant
- K213254Axialis Ophthalmic Ultrasound SystemQuantel Medical · 2021 · 3 generations on0descendants
- K183414AbsoluQuantel Medical · 2019 · cites it directly0descendants
- K152318MD-2300S Ultrasonic A/B Scanner for OphthalmologyMEDA Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K926251 | B-Scan Opthalmic Ultrasound Imaging System | Biovision, Inc. | 1993 | — |
| −1 | K021683 | Cinescan S | Quantel Medical | 2002 | — |
| 0 (this device) | K051851 | Aviso Ophthalmic Ultrasound System | Quantel Medical | 2005 | — |
| +1 | K094038 | Compact Touch | Quantel S.A. | 2010 | — |
| +2 | K180265 | COMPACT TOUCH Ophthalmic Ultrasound System | Quantel Medical | 2018 | — |
| +3 | K213254 | Axialis Ophthalmic Ultrasound System | Quantel Medical | 2021 | — |
| +1 | K183414 | Absolu | Quantel Medical | 2019 | — |
| +1 | K152318 | MD-2300S Ultrasonic A/B Scanner for Ophthalmology | MEDA Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K021683 | Cinescan SSummary page 1…Classification name: System, Imaging, Ultrasonic, Ophthalmic, 9801YO (3) Legally-marketed predicate device The predicate device is Quantel Cinescan S, K021683. (4) Description The Aviso is a combined ophthalmic A and B scan system that can also be used for biome… | 2002 |
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 12 years and passes through 2 companies; a new generation was cleared every 8.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K094038 (Quantel S.A., 2010) 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 intended use of the Aviso is for diagnostic imaging of the eye by A and B scans and for biometric measurements of the eye.
The intended use of the Aviso 10 MHz B-scan transducer is for diagnostic imaging of the eye by B scans..
The Quantel Medical Aviso 8 Mhz A-scan transducer is intended to be used with the Quantel Aviso A-scans of the eye and for biometric measurements.
The intended use of the Aviso B-HF B-scan transducer is for diagnostic imaging of the eye by B scans and for biometric measurements of the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051851: Aviso Ophthalmic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051851
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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