510(k) · Cleared
ClearedDiasus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dynamic Imaging, Ltd. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Oct 5, 2001 as substantially equivalent to K944485 (Biosound, Inc., 1995) and 2 other predicates after a 15-day review. Its family tree reaches back 3 generations to 1995. 10 later devices descend from it.
- Decided
- Oct 5, 2001
- Review
- 15 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K944485 (1995). 10 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK944485 4000 AU Ultrasound Imaging SystemBiosound, Inc. · 1995
- 2 generations backK980468 AU5 Ultrasound Imaging SystemBiosound Esaote, Inc. · 1998
- 1 generation backK990360 AU6Biosound Esaote, Inc. · 1999
- This deviceK013142 DiasusDynamic Imaging, Ltd. · 2001
- Descendant · cites it directly · 8 of its ownK050551 Voyager Personal Imaging DeviceArdent Sound, Inc. · 2005
- Descendant · 2 generations on · 5 of its ownK132736 Accuro 3000 Ultrasound ScannerRivanna Medical, LLC · 2014
- Descendant · 3 generations on · 3 of its ownK171594 AccuroRivanna Medical, LLC · 2017
- Descendant · 4 generations on · 2 of its ownK243937 Accuro 3SRivanna Medical, Inc. · 2025
- Descendant · cites it directly · 2 of its ownK060800 Seeker/Spark Ultrasound SystemArdent Sound, Inc. · 2006
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K050551Voyager Personal Imaging DeviceArdent Sound, Inc. · 2005 · cites it directly8descendants
- K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC · 2014 · 2 generations on5descendants
- K171594AccuroRivanna Medical, LLC · 2017 · 3 generations on3descendants
- K243937Accuro 3SRivanna Medical, Inc. · 2025 · 4 generations on2descendants
- K060800Seeker/Spark Ultrasound SystemArdent Sound, Inc. · 2006 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944485 | 4000 AU Ultrasound Imaging System | Biosound, Inc. | 1995 | — |
| −2 | K980468 | AU5 Ultrasound Imaging System | Biosound Esaote, Inc. | 1998 | — |
| −1 | K990360 | AU6 | Biosound Esaote, Inc. | 1999 | — |
| 0 (this device) | K013142 | Diasus | Dynamic Imaging, Ltd. | 2001 | — |
| +1 | K050551 | Voyager Personal Imaging Device | Ardent Sound, Inc. | 2005 | — |
| +2 | K132736 | Accuro 3000 Ultrasound Scanner | Rivanna Medical, LLC | 2014 | — |
| +3 | K171594 | Accuro | Rivanna Medical, LLC | 2017 | — |
| +4 | K243937 | Accuro 3S | Rivanna Medical, Inc. | 2025 | — |
| +1 | K060800 | Seeker/Spark Ultrasound System | Ardent Sound, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K944485 | 4000 AU Ultrasound Imaging SystemSummary page 1…ber Product Code Classification Name Ultrasonic Pulsed Echo Imaging System 892.1560 90-1YO Predicate Devices Trade name Manufacturer 510(k) AU4 Biosound Asaote Inc K#944485 AUS Biosound Asaote Inc K#980468 AU6 Biosound Asaote Inc K#990360 The Diasus is of comparable type and substantially equivalent… | 1995 |
| * | K980468 | AU5 Ultrasound Imaging SystemSummary page 1…Name Ultrasonic Pulsed Echo Imaging System 892.1560 90-1YO Predicate Devices Trade name Manufacturer 510(k) AU4 Biosound Asaote Inc K#944485 AUS Biosound Asaote Inc K#980468 AU6 Biosound Asaote Inc K#990360 The Diasus is of comparable type and substantially equivalent to the legally marketed Biosound… | 1998 |
| * | K990360 | AU6Summary page 1…ng System 892.1560 90-1YO Predicate Devices Trade name Manufacturer 510(k) AU4 Biosound Asaote Inc K#944485 AUS Biosound Asaote Inc K#980468 AU6 Biosound Asaote Inc K#990360 The Diasus is of comparable type and substantially equivalent to the legally marketed Biosound Asaote Inc AU4, AUS and AUG6. It… | 1999 |
What descends from it? (10)
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 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K050551 (Ardent Sound, Inc., 2005) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K944485.
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 Diasus Ultrasound Imaging system is intended for performing no-invasive diagnostic general ultrasound studies. Such uses include the following; Abdominal, Cardiac, Paediatric, Small organs including, Thyroid, Parathyroid, Breast and Testes, Neonatal / adult cephalic, Peripheral vascular, and Conventional / Superficial Musculoskeletal.
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/K013142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013142: Diasus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013142
Report an extraction error
Are you the manufacturer?
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