510(k) · Cleared
ClearedIVIEW
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ondemandsoft · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Apr 19, 2006 as substantially equivalent to K023473 (Bio Medi Com, 2002) after a 142-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Apr 19, 2006
- Review
- 142 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K941322 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK941322 Echo-ScanTomographic Tech · 1995
- 5 generations backK963807 Tomtec Echo-ScanTomtec Imaging Systems, Inc. · 1996
- 4 generations backK980308 Echotech 3D FreescanEchotech 3D Imaging Systems GmbH · 1998
- 3 generations backK994385 Baby FaceSonora Medical Systems · 2000
- 2 generations backK020068 Sonoreal 3D SystemBio Medi Com · 2002
- 1 generation backK023473 Sonoreal 3DBio Medi Com · 2002
- This deviceK053306 IVIEWOndemandsoft · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K941322 | Echo-Scan | Tomographic Tech | 1995 | — |
| −5 | K963807 | Tomtec Echo-Scan | Tomtec Imaging Systems, Inc. | 1996 | — |
| −4 | K980308 | Echotech 3D Freescan | Echotech 3D Imaging Systems GmbH | 1998 | — |
| −3 | K994385 | Baby Face | Sonora Medical Systems | 2000 | — |
| −2 | K020068 | Sonoreal 3D System | Bio Medi Com | 2002 | — |
| −1 | K023473 | Sonoreal 3D | Bio Medi Com | 2002 | — |
| 0 (this device) | K053306 | IVIEW | Ondemandsoft | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K023473 | Sonoreal 3DSummary page 1…oduct Code: IYO Regulation Number: 892.1560 Device Class: 2 Predicate Device The iVicw is substantially equivalent to the SonoReal system marketed by Biomedicom tinder K023473. A comparison of devices is provided below: 1 Scanning 2 - 6 second Few… | 2002 |
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 11 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- None of the 7 ancestors has a 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.
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 iView[ M is intended to be used by or under the direction of qualified medical personnel during prenatal monitoring, to visualize fetal features in a reconstructed 3D image that they may wish to exam more closely during routine 2D fetal diagnostic ultrasound imaging examinations, and to assist patient's understanding in communicating diagnostic results in a form that may be more easily understood. It does not provide quantitative measurements or…
Read the full statement (125 words)
The iView[ M is intended to be used by or under the direction of qualified medical personnel during prenatal monitoring, to visualize fetal features in a reconstructed 3D image that they may wish to exam more closely during routine 2D fetal diagnostic ultrasound imaging examinations, and to assist patient's understanding in communicating diagnostic results in a form that may be more easily understood. It does not provide quantitative measurements or diagnostic interpretations.
The subject device may only be used in an adjunctive capacity with standard diagnostic ultrasound imaging techniques and that no clinical decisions or diagnostic interpretations should be made based solely on the use of this device.
31) image reconstructed from this software is referring use only and is not responsible for any diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053306 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053306: IVIEW.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053306
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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