510(k) · Cleared
ClearedSonoreal 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio Medi Com · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Sep 26, 2001 as substantially equivalent to K980308 (Echotech 3D Imaging Systems GmbH, 1998) after an 85-day review. Its family tree reaches back 3 generations to 1995. 3 later devices descend from it.
- Decided
- Sep 26, 2001
- Review
- 85 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K941322 (1995). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK941322 Echo-ScanTomographic Tech · 1995
- 2 generations backK963807 Tomtec Echo-ScanTomtec Imaging Systems, Inc. · 1996
- 1 generation backK980308 Echotech 3D FreescanEchotech 3D Imaging Systems GmbH · 1998
- This deviceK012084 Sonoreal 3DBio Medi Com · 2001
- Descendant · cites it directly · 2 of its ownK020068 Sonoreal 3D SystemBio Medi Com · 2002
- Descendant · cites it directly · 1 of its ownK023473 Sonoreal 3DBio Medi Com · 2002
- Descendant · 2 generations on · 0 of its ownK053306 IVIEWOndemandsoft · 2006
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941322 | Echo-Scan | Tomographic Tech | 1995 | — |
| −2 | K963807 | Tomtec Echo-Scan | Tomtec Imaging Systems, Inc. | 1996 | — |
| −1 | K980308 | Echotech 3D Freescan | Echotech 3D Imaging Systems GmbH | 1998 | — |
| 0 (this device) | K012084 | Sonoreal 3D | Bio Medi Com | 2001 | — |
| +1 | K020068 | Sonoreal 3D System | Bio Medi Com | 2002 | — |
| +1 | K023473 | Sonoreal 3D | Bio Medi Com | 2002 | — |
| +2 | K053306 | IVIEW | Ondemandsoft | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K980308 | Echotech 3D FreescanSummary page 1…lysis System Classification Name(s): | System, Imaging, Pulsed Echo, Ulirasonic Classification Number: = 90IYO 807.92(a)(3) ‘ Predicate Device(s) EchoTech’ . 3D FreeScan K980308 Additional Substantial Eqdivalence Information is provided in the following substantial Equivalence Comparison Table. _Sk23 ==… | 1998 |
What descends from it? (3)
2 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 6 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K020068 (Bio Medi Com, 2002) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K980308.
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?
Intended to be used by or under the direction of a physician and in conjunction with standard ultrasound system to provide 3D clinical imaging in fetal and gynecological applications. The SONOReal™ system does not currently provide any quantitative measurement capabilities or diagnostic interpretations. It is intended to visualize features that you may wish to examine more closely in routine 2D ultrasound diagnostic imaging examinations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012084 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012084: Sonoreal 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012084
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026