510(k) · Cleared
ClearedVoyager Personal Imaging Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ardent Sound, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Mar 22, 2005 as substantially equivalent to K013142 (Dynamic Imaging, Ltd., 2001) and 2 other predicates after a 19-day review. Its family tree reaches back 4 generations to 1995. 8 later devices descend from it.
- Decided
- Mar 22, 2005
- Review
- 19 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K944485 (1995). 5 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK944485 4000 AU Ultrasound Imaging SystemBiosound, Inc. · 1995
- 3 generations backK980468 AU5 Ultrasound Imaging SystemBiosound Esaote, Inc. · 1998
- 2 generations backK990360 AU6Biosound Esaote, Inc. · 1999
- 1 generation backK013142 DiasusDynamic Imaging, Ltd. · 2001
- This deviceK050551 Voyager Personal Imaging DeviceArdent Sound, Inc. · 2005
- Descendant · cites it directly · 5 of its ownK132736 Accuro 3000 Ultrasound ScannerRivanna Medical, LLC · 2014
- Descendant · 2 generations on · 3 of its ownK171594 AccuroRivanna Medical, LLC · 2017
- Descendant · 3 generations on · 2 of its ownK243937 Accuro 3SRivanna Medical, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK102253 Echo BlasterTelemed · 2011
- Descendant · 4 generations on · 0 of its ownK253452 Accuro 3SRivanna Medical, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC · 2014 · cites it directly5descendants
- K171594AccuroRivanna Medical, LLC · 2017 · 2 generations on3descendants
- K243937Accuro 3SRivanna Medical, Inc. · 2025 · 3 generations on2descendants
- K102253Echo BlasterTelemed · 2011 · cites it directly1descendant
- K253452Accuro 3SRivanna Medical, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944485 | 4000 AU Ultrasound Imaging System | Biosound, Inc. | 1995 | — |
| −3 | K980468 | AU5 Ultrasound Imaging System | Biosound Esaote, Inc. | 1998 | — |
| −2 | K990360 | AU6 | Biosound Esaote, Inc. | 1999 | — |
| −1 | K013142 | Diasus | Dynamic Imaging, Ltd. | 2001 | — |
| 0 (this device) | K050551 | Voyager Personal Imaging Device | Ardent Sound, Inc. | 2005 | — |
| +1 | K132736 | Accuro 3000 Ultrasound Scanner | Rivanna Medical, LLC | 2014 | — |
| +2 | K171594 | Accuro | Rivanna Medical, LLC | 2017 | — |
| +3 | K243937 | Accuro 3S | Rivanna Medical, Inc. | 2025 | — |
| +1 | K102253 | Echo Blaster | Telemed | 2011 | — |
| +4 | K253452 | Accuro 3S | Rivanna Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K013142 | DiasusSummary page 1…Trade Name Manufacturer 510(k) DIASUS Dynamic Imaging Ltd K013142 AU5 Esaote K980468 AU5/3D Esao… | 2001 |
| * | K980468 | AU5 Ultrasound Imaging SystemSummary page 1…DIASUS Dynamic Imaging Ltd K013142 AU5 Esaote K980468 AU5/3D Esaote K000681 The Voyager is of comparable type and s… | 1998 |
| * | K000681 | AU5, AU6Summary page 1…AU5 Esaote K980468 AU5/3D Esaote K000681 The Voyager is of comparable type and substantially equivalent to the legally marketed… | 2000 |
What descends from it? (8)
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 10 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K132736 (Rivanna Medical, LLC, 2014) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K013142.
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?
Imaging: Fetal, Abdominal, 3-D Visualization (non-measuring), Small organ (thyroid and breast). Musculoskeletal (Conventional), Peripheral Vessel and Needle Guidance.
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/K050551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050551: Voyager Personal Imaging Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050551
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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