510(k) · Cleared
ClearedAxis Nano Opthalmic Biometer Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantel Medical S.A. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Dec 22, 2010 as substantially equivalent to K094038 (Quantel S.A., 2010) after a 156-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Dec 22, 2010
- Review
- 156 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K926251 (1993). 8 ancestors in all, the oldest K920906 (1992). No later device cites it as a predicate yet.
- Root · 4 generations backK926251 B-Scan Opthalmic Ultrasound Imaging SystemBiovision, Inc. · 1993
- 3 generations backK021683 Cinescan SQuantel Medical · 2002
- 2 generations backK051851 Aviso Ophthalmic Ultrasound SystemQuantel Medical · 2005
- 1 generation backK094038 Compact TouchQuantel S.A. · 2010
- This deviceK102027 Axis Nano Opthalmic Biometer Ultrasound SystemQuantel Medical S.A. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K926251 | B-Scan Opthalmic Ultrasound Imaging System | Biovision, Inc. | 1993 | — |
| −3 | K021683 | Cinescan S | Quantel Medical | 2002 | — |
| −2 | K051851 | Aviso Ophthalmic Ultrasound System | Quantel Medical | 2005 | — |
| −1 | K094038 | Compact Touch | Quantel S.A. | 2010 | — |
| 0 (this device) | K102027 | Axis Nano Opthalmic Biometer Ultrasound System | Quantel Medical S.A. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 2000 | 2 | 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 |
|---|---|---|---|
| * | K094038 | Compact TouchSummary page 2…Predicate Devices [21 CPR 807.92(a)(3)] The AXIS NANO uses similar technology and physical output characteristics as the following predicate devices: K09403 8 Quantel Medical Compact TOUCH Ophthalmic Ultrasound System E. Device Description [21 CFR 807.92(a)(4)] The AXIS NANO is… | 2010 |
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?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K094038.
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 QUANTEL MEDICAL AXIS NANO Ophthalmic Ultrasound System and the probes that are used with it are indicated for the biometric measurement of the eye including:
Axial Length measurement of the eye by ultrasonic means.
Implanted IOL power calculation, using the Axial Length measurement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102027: Axis Nano Opthalmic Biometer 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/K102027
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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