510(k) · Cleared
ClearedAccuro 3000 Ultrasound Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rivanna Medical, LLC · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Mar 11, 2014 as substantially equivalent to K071217 (Verathon Incorporated, 2007) and 2 other predicates after a 189-day review. Its family tree reaches back 10 generations to 1995. 5 later devices descend from it.
- Decided
- Mar 11, 2014
- Review
- 189 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K935595 (1995). 92 ancestors in all, the oldest K850478 (1985). 5 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 6 generations between
- 3 generations backK063761 Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
- 1 generation backK102153 Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011
- This deviceK132736 Accuro 3000 Ultrasound ScannerRivanna Medical, LLC · 2014
- Descendant · cites it directly · 3 of its ownK171594 AccuroRivanna Medical, LLC · 2017
- Descendant · 2 generations on · 2 of its ownK243937 Accuro 3SRivanna Medical, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK253452 Accuro 3SRivanna Medical, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK254021 Accuro XVRivanna Medical, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK192388 SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC · 2020
Show all 10 generations
- Root · 10 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 9 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 8 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 7 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 6 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 5 generations backK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 4 generations backK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 3 generations backK063761 Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
- 1 generation backK102153 Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011
- This deviceK132736 Accuro 3000 Ultrasound ScannerRivanna Medical, LLC · 2014
Most influential descendants
Showing 5 of 5 · See all- K171594AccuroRivanna Medical, LLC · 2017 · cites it directly3descendants
- K243937Accuro 3SRivanna Medical, Inc. · 2025 · 2 generations on2descendants
- K253452Accuro 3SRivanna Medical, Inc. · 2026 · 3 generations on0descendants
- K254021Accuro XVRivanna Medical, Inc. · 2026 · 3 generations on0descendants
- K192388SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −9 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −8 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −7 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −6 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −5 | K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −4 | K052410 | Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −3 | K063761 | Acuson P10 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −2 | K090505 | Speq Ultrasound System | Signostics Pty, Ltd. | 2009 | — |
| −1 | K102153 | Mobius Ultrasound Imaging System | Mobisante, Inc. | 2011 | — |
| 0 (this device) | K132736 | Accuro 3000 Ultrasound Scanner | Rivanna Medical, LLC | 2014 | — |
| +1 | K171594 | Accuro | Rivanna Medical, LLC | 2017 | — |
| +2 | K243937 | Accuro 3S | Rivanna Medical, Inc. | 2025 | — |
| +3 | K253452 | Accuro 3S | Rivanna Medical, Inc. | 2026 | — |
| +3 | K254021 | Accuro XV | Rivanna Medical, Inc. | 2026 | — |
| +1 | K192388 | SonoVision Ultrasound Imaging System | Tissue Differentiation Intelligence, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 6 | 0 |
| 1996 | 5 | 0 |
| 1997 | 7 | 0 |
| 1998 | 5 | 0 |
| 1999 | 11 | 0 |
| 2000 | 6 | 0 |
| 2001 | 6 | 0 |
| 2002 | 7 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2007 | 3 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K071217 | Bladderscan Bvi 9400 UltrasoundSummary page 1…ITX21 CFR892.1570 Diagnostic Ultrasound Transducers Premarket Notification: K071217, May 17t 2004 Manufacturer: Verathon, Inc. Predicate Device Trade Name: Voyager… | 2007 |
| * | K050551 | Voyager Personal Imaging DeviceSummary page 1…ITX21 CFR892.1570 Diagnostic Ultrasound Transducers Premarket Notification: K050551, March 2 2nd 2005 Manufacturer: Ardent, Inc Predicate Device Trade… | 2005 |
| * | K102153 | Mobius Ultrasound Imaging SystemSummary page 2…ITX21 CFRB92.1570 Diagnostic Ultrasound Transducers Premarket Notification: K102153, January 20th 2011 Manufacturer: Mobisante, Inc. Device Description The… | 2011 |
What descends from it? (5)
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 19 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 92 ancestors have a recall of any class.
- Of its descendants, K171594 (Rivanna Medical, LLC, 2017) has gone furthest, with 3 descendants of its own.
- 11 other devices also cite its predicate K071217.
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. 2014, this device’s year, is highlighted.
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 Accuro 3000 ultrasound scanner is intended for diagnostic ultrasound imaging of the human body in the following clinical applications: Abdominal, Musculoskeletal (Conventional and superficial). Cardiac. Peripheral vascular. A typical examination using the Accuro 3000 is guidance of neuraxial anesthesia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132736 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132736: Accuro 3000 Ultrasound Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132736
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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