510(k) · Cleared
ClearedCinescan S
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 Jun 21, 2002 as substantially equivalent to K926251 (Biovision, Inc., 1993) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 1993. 7 later devices descend from it.
- Decided
- Jun 21, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K926251 (1993). 2 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK926251 B-Scan Opthalmic Ultrasound Imaging SystemBiovision, Inc. · 1993
- This deviceK021683 Cinescan SQuantel Medical · 2002
- Descendant · cites it directly · 6 of its ownK051851 Aviso Ophthalmic Ultrasound SystemQuantel Medical · 2005
- Descendant · 2 generations on · 3 of its ownK094038 Compact TouchQuantel S.A. · 2010
- Descendant · 3 generations on · 1 of its ownK180265 COMPACT TOUCH Ophthalmic Ultrasound SystemQuantel Medical · 2018
- Descendant · 4 generations on · 0 of its ownK213254 Axialis Ophthalmic Ultrasound SystemQuantel Medical · 2021
- Descendant · 2 generations on · 0 of its ownK183414 AbsoluQuantel Medical · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K051851Aviso Ophthalmic Ultrasound SystemQuantel Medical · 2005 · cites it directly6descendants
- K094038Compact TouchQuantel S.A. · 2010 · 2 generations on3descendants
- K180265COMPACT TOUCH Ophthalmic Ultrasound SystemQuantel Medical · 2018 · 3 generations on1descendant
- K213254Axialis Ophthalmic Ultrasound SystemQuantel Medical · 2021 · 4 generations on0descendants
- K183414AbsoluQuantel Medical · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926251 | B-Scan Opthalmic Ultrasound Imaging System | Biovision, Inc. | 1993 | — |
| 0 (this device) | K021683 | Cinescan S | Quantel Medical | 2002 | — |
| +1 | K051851 | Aviso Ophthalmic Ultrasound System | Quantel Medical | 2005 | — |
| +2 | K094038 | Compact Touch | Quantel S.A. | 2010 | — |
| +3 | K180265 | COMPACT TOUCH Ophthalmic Ultrasound System | Quantel Medical | 2018 | — |
| +4 | K213254 | Axialis Ophthalmic Ultrasound System | Quantel Medical | 2021 | — |
| +2 | K183414 | Absolu | Quantel Medical | 2019 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K926251 | B-Scan Opthalmic Ultrasound Imaging System Our reading of the summary gave K926521, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “B-SCAN”. | 1993 |
| * | K000554 | Pocket Ultrasonic Ophthalmic Pachymeter, Biometry Transducer for PocketSummary page 1…nufactured by Biovision and then B.V.1 (the predecessor company to Quantel Medical). This device included both A and B scan capability. 2. The Axis TI, K000554, manufactured by Quantel Medical. This was the subject of a Special 5 lo&), and was also a modification of the “B-scan.”… | 2000 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051851 | Aviso Ophthalmic Ultrasound System | 2005 | 6 |
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 intended use of the Cinescan S is for diagnostic imaging of the eye by A and B scans and for biometric measurements of the eye.
The intended use of the Cinescan S 10 MHz B-scan transducer is for diagnostic imaging of the eye by B scans..
The Quantel Medical Cinescan * Mhz A-scan transducer is intended to be used with the Quantel Cinescan S A-scans of the eye and for biometric measurements.
The intended use of the Cinescan S 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/K021683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021683: Cinescan S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021683
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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