510(k) · Cleared
ClearedMELODY, Remote Control System for Ultrasound Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adecho Tech · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jun 12, 2017 as substantially equivalent to K082543 (Sonocine, Inc., 2008) after a 392-day review. Its family tree reaches back 6 generations to 1992. 1 later device descends from it.
- Decided
- Jun 12, 2017
- Review
- 392 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K922470 (1992). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
- 5 generations backK993802 Sharpview Image Enhancement SystemContext Vision AB · 2000
- 4 generations backK024028 Sharp View Image Enhancement SystemContext Vision AB · 2003
- 3 generations backK052355 Automated Breast Ultrasound System, Model AbusU-Systems, Inc. · 2005
- 2 generations backK070477 Orison Embrace SystemOrison Corporation · 2007
- 1 generation backK082543 Sonocine Adjunctive Breast Ultrasound System (Abu), Model 100Sonocine, Inc. · 2008
- This deviceK161354 MELODY, Remote Control System for Ultrasound ProbeAdecho Tech · 2017
- Descendant · cites it directly · 0 of its ownK260190 ArthurROPCA ApS · 2026
Most influential descendants
Showing 1 of 1 · See all- K260190ArthurROPCA ApS · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922470 | Ies, Image Enhancement System | Open Mri, Inc. | 1992 | — |
| −5 | K993802 | Sharpview Image Enhancement System | Context Vision AB | 2000 | — |
| −4 | K024028 | Sharp View Image Enhancement System | Context Vision AB | 2003 | — |
| −3 | K052355 | Automated Breast Ultrasound System, Model Abus | U-Systems, Inc. | 2005 | — |
| −2 | K070477 | Orison Embrace System | Orison Corporation | 2007 | — |
| −1 | K082543 | Sonocine Adjunctive Breast Ultrasound System (Abu), Model 100 | Sonocine, Inc. | 2008 | — |
| 0 (this device) | K161354 | MELODY, Remote Control System for Ultrasound Probe | Adecho Tech | 2017 | — |
| +1 | K260190 | Arthur | ROPCA ApS | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K082543 | Sonocine Adjunctive Breast Ultrasound System (Abu), Model 100Summary page 5…3. IYN Review Panel: Radiology FDA Document Numbers Q150951 Related To Melody Predicate Device(s): K082543, SonoCiné Adjunctive Breast Ultrasound System (ABU), Model 100 III. PREDICATE DEVICE… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260190 | Arthur | 2026 | 0 |
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 25 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K260190 (ROPCA ApS, 2026) has gone furthest, with 0 descendants of its own.
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. 2017, 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 MELODY is intended to hold the external ultrasound transducer of cleared ultrasound equipment and provide a remotely-located, expert sonographer the ability to manipulate the transducer in real time through an Internet connection to obtain the ultrasound views required to assess the patient. The MELODY robot frame at the remotely-located patient is prepared and positioned by a trained assistant at the direction of the expert sonographer through a…
Read the full statement (121 words)
The MELODY is intended to hold the external ultrasound transducer of cleared ultrasound equipment and provide a remotely-located, expert sonographer the ability to manipulate the transducer in real time through an Internet connection to obtain the ultrasound views required to assess the patient. The MELODY robot frame at the remotely-located patient is prepared and positioned by a trained assistant at the direction of the expert sonographer through a suitable third-party videoconferencing system. Sonograms are transmitted from the patient location from cleared ultrasound equipment through digital telecommunication to the expert sonographer. Indications for the MELODY are tabulated in the Diagnostic Ultrasound Indications table. MELODY may also be used when a physician wants to have a colleague not on-site provide a second opinion.
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/K161354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161354: MELODY, Remote Control System for Ultrasound Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161354
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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