510(k) · Cleared
ClearedDigital Ultrasonic Diagnostic Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edan Instruments, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jun 19, 2009 as substantially equivalent to K052113 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2005) and 1 other predicate after a 9-day review. Its family tree reaches back 5 generations to 1995. 25 later devices descend from it.
- Decided
- Jun 19, 2009
- Review
- 9 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K934139 (1995). 17 ancestors in all, the oldest K852159 (1985). 25 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 4 generations backK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
- 3 generations backK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
- 2 generations backK042540 Philips IU22 Ultrasound SystemPhilips Ultrasound, Inc. · 2004 · Recalled
- 1 generation backK060949 DP-6600 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- This deviceK091680 Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc. · 2009
- Descendant · cites it directly · 22 of its ownK110999 Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc. · 2011
- Descendant · 2 generations on · 21 of its ownK123249 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2013
- Descendant · 3 generations on · 13 of its ownK142511 U50 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2015
- Descendant · 3 generations on · 12 of its ownK150999 Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2015
- Descendant · 4 generations on · 9 of its ownK161300 Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2016
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K110999Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc. · 2011 · cites it directly22descendants
- K123249Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2013 · 2 generations on21descendants
- K142511U50 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2015 · 3 generations on13descendants
- K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2015 · 3 generations on12descendants
- K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2016 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| −4 | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
| −3 | K022824 | Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X… | Tomtec Imaging Systems GmbH | 2002 | — |
| −2 | K042540 | Philips IU22 Ultrasound System | Philips Ultrasound, Inc. | 2004 | 4 |
| −1 | K060949 | DP-6600 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| 0 (this device) | K091680 | Digital Ultrasonic Diagnostic Imaging System | Edan Instruments, Inc. | 2009 | — |
| +1 | K110999 | Digital Ultrasonic Diagnostic Imaging System | Edan Instruments, Inc. | 2011 | — |
| +2 | K123249 | Diagnostic Ultrasound System | Edan Instruments, Inc. | 2013 | — |
| +3 | K142511 | U50 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2015 | — |
| +3 | K150999 | Acclarix Diagnostic Ultrasound System | Edan Instruments, Inc. | 2015 | — |
| +4 | K161300 | Acclarix AX8 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 7 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 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 |
|---|---|---|---|
| * | K052113 | DP-6600 Ultrasonic Diagnostic Imaging SystemSummary page 1…Product code: ITX Regulatory Class: II 3. Predicate Device: DP-6600 Digital Ultrasonic Diagnostic Imaging System. K0521 13 Manufacturer: SHENZHEN MIhNDRAY BIG0-MEDICAL ELECTRONICS CO., LTD DP-6600 D… | 2005 |
| * | K060949 | DP-6600 Digital Ultrasonic Diagnostic Imaging SystemSummary page 1…Manufacturer: SHENZHEN MIhNDRAY BIG0-MEDICAL ELECTRONICS CO., LTD DP-6600 Digital Ultrasonic Diagnostic Imaging System. K060949 Manufacturer: SHENZHEN MINDRAY BIG-MEDICAL ELECTRONICS CO., LTD 4. Device DUS 3/DUS… | 2006 |
What descends from it? (25)
See all 253 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 14 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K110999 (Edan Instruments, Inc., 2011) has gone furthest, with 22 descendants of its own.
- 1 other device also cites its predicate K052113.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
The DUS 3 & DUS 6 Digital Ultrasonic Diagnostic Imaging System is intended for diagnostic ultrasound imaging analysis in gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The DUS 3/ DUS 6 Digital Ultrasonic Diagnostic Imaging System is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus; Abdomen; Pediatrics; Small Organ; Neonatal Cephalic; Cardiology; Peripheral Vessel; Musculo-skeleton (both Conventional and Superficial); Urology (including prostate); Transrecta and Transvagina.
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/K091680 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091680: Digital Ultrasonic Diagnostic Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091680
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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