510(k) · Cleared
ClearedEchotech Easy 3D Family, Echotech 3D Freescan, Echotech Easyarchive, Echotech Quanticon, Echotech Easystress
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Echotech 3D Imaging Systems, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Apr 4, 2002 as substantially equivalent to K980308 (Echotech 3D Imaging Systems GmbH, 1998) and 1 other predicate after a 199-day review. Its family tree reaches back 3 generations to 1995. 3 later devices descend from it.
- Decided
- Apr 4, 2002
- Review
- 199 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
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 deviceK013088 Echotech Easy 3D Family, Echotech 3D Freescan, Echotech Easyarchive…Echotech 3D Imaging Systems, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK030635 The Obsidian Pacs SystemObsidian Medical Technology, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK060035 MdxnetCybermdx, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK031567 3D Invivo by CsistChung-Shan Institute of Science and Technology · 2003
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) | K013088 | Echotech Easy 3D Family, Echotech 3D Freescan, Echotech Easyarchive, Echotech… | Echotech 3D Imaging Systems, Inc. | 2002 | — |
| +1 | K030635 | The Obsidian Pacs System | Obsidian Medical Technology, Inc. | 2003 | — |
| +1 | K060035 | Mdxnet | Cybermdx, Inc. | 2006 | — |
| +2 | K031567 | 3D Invivo by Csist | Chung-Shan Institute of Science and Technology | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (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 |
|---|---|---|---|
| * | K980308 | Echotech 3D FreescanSummary page 2…Page 2 === Classification Class: I Panel: Radiology CFR Section: 21 CFR 892.2050 Product Code: LLZ (image processing system) Predicate Devices EchoTech 3D FreeScan K980308 May 6, 1998 Tom-Tec Echo-Scan K963807 December 18, 1996 Device Description The following products produced by Echotech 3D Imagi… | 1998 |
| * | K963807 | Tomtec Echo-ScanSummary page 2…Panel: Radiology CFR Section: 21 CFR 892.2050 Product Code: LLZ (image processing system) Predicate Devices EchoTech 3D FreeScan K980308 May 6, 1998 Tom-Tec Echo-Scan K963807 December 18, 1996 Device Description The following products produced by Echotech 3D Imaging Systems are included in this 510(k)… | 1996 |
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 7 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, K030635 (Obsidian Medical Technology, Inc., 2003) has gone furthest, with 1 descendant 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?
The EchoTech Easy3D is indicated for acquisition of related sets of 2D ultrasound images and 3D reconstruction of ultrasound images. It is intended to acquire, analyze, store, and retrieve digital ultrasound images for computerized 3D image processing. Easy3D is an add-on accessory to existing diagnostic ultrasound systems. Easy3D employs freehand scanning without the use of a coordinate and position sensor, therefore, the extension of the data set in…
Read the full statement (414 words)
The EchoTech Easy3D is indicated for acquisition of related sets of 2D ultrasound images and 3D reconstruction of ultrasound images. It is intended to acquire, analyze, store, and retrieve digital ultrasound images for computerized 3D image processing. Easy3D is an add-on accessory to existing diagnostic ultrasound systems. Easy3D employs freehand scanning without the use of a coordinate and position sensor, therefore, the extension of the data set in the scanning direction is unknown. The images are not intended for use in diagnosis or quantitative measurements. The Easy3D is intended as a general purpose digital 3D ultrasound image processing tool for use in obstetrics for qualitative evaluation of deformities and determination of the need for further fetal ultrasound studies.
The EchoTech 3D FreeScan system is indicated for acquisition of related sets of 2D ultrasound images and 3D reconstruction of ultrasound images. It is intended to acquire, analyze, store, and retrieve digital ultrasocund images for computerized 3D image processing. Easy3D is an add-on accessory to existing diagnostic ultrasound systems. Easy3D employs freehand scanning with the use of a coordinate and position sensor and, optionally, with heart cycle (R-Peak) triggering, which enables cardiovascular imaging.
The EchoTech EasyArchive system is indicated to acquire, digitize, archive, and retrieve single or sequences of 2D ultrasound images. EasyArchive is an add-on accessory to existing diagnostic ultrasound systems. EasyArchive is intended as a general purpose digital ultrasound image processing and archiving tool for use in radiology, neurology, gastroenterology, urology, surgery, orthopedics, cardiology, oncology, obstetrics and gynecology.
The EchoTech Quanticon is indicated in the acquisition of either heart cycle (R-Peak) triggered or nontriggered sequences of 2D ultrasound images for use in the evaluation of contrast agent-based ultrasound exams. In the sequence of images multiple Regions Of Interest (ROIl) can be selected. Inside these chosen regions the average gray value or the number of color pixels is calculated over time. Quanticon is intended an add-on accessory to existing diagnostic ultrasound systems. Quanticon is intended as a general digital ultrasound processing and archiving tool for use in cardiology, radiology, and neurology.
The EchoTech EasyStress system is indicated for the acquisition of heart cycle (R-Peak) triggered sequences of 2D ultrasound images for use in performing, scoring, measuring, reporting, and archiving stress echo studies. The EasyStress system utilizes the ASE Standard for Wall Motion Scoring to quantify wall motion abnormalities of the heart. EasyStress is an add-on accessory to existing diagnostic ultrasound systems. EasyStress is a digital ultrasound image processing and archiving tool for use in cardiology.
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/K013088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013088: Echotech Easy 3D Family, Echotech 3D Freescan, Echotech Easyarchive, Echotech Quanticon, Echotech Easystress.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013088
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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