510(k) · Cleared
ClearedMobius Ultrasound Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mobisante, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jan 20, 2011 as substantially equivalent to K070907 (Regulatory Management Services, 2007) and 2 other predicates after a 174-day review. Its family tree reaches back 9 generations to 1995. 2 of the 185 devices in its family, counting itself, have a Class I recall. 103 later devices descend from it.
- Decided
- Jan 20, 2011
- Review
- 174 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K935595 (1995). 81 ancestors in all, the oldest K850478 (1985). 103 later devices descend from it, 4 citing it directly. 2 of the 185 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 5 generations between
- 3 generations backK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 2 generations backK063761 Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 1 generation backK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
- This deviceK102153 Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011
- Descendant · cites it directly · 87 of its ownK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 79 of its ownK152899 Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 43 of its ownK162549 Lumify Ultrasound SystemPhilips Health Care · 2016 · Recalled
- Descendant · cites it directly · 33 of its ownK151339 SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd. · 2015
- Descendant · 4 generations on · 31 of its ownK192226 Lumify Diagnostic Ultrasound SystemPhilips Health Care · 2019 · Recalled
Show all 9 generations
- Root · 9 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 8 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 7 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 6 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 5 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 4 generations backK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 3 generations backK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 2 generations backK063761 Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 1 generation backK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
- This deviceK102153 Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011
Showing 5 of 103 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 103 · See all- K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · cites it directly87descendants
- K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · 2 generations on79descendants
- K162549Lumify Ultrasound SystemPhilips Health Care · 2016 · 3 generations on43descendants
- K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd. · 2015 · cites it directly33descendants
- K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care · 2019 · 4 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −8 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −7 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −6 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −5 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −4 | K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −3 | K052410 | Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −2 | K063761 | Acuson P10 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −1 | K090505 | Speq Ultrasound System | Signostics Pty, Ltd. | 2009 | — |
| 0 (this device) | K102153 | Mobius Ultrasound Imaging System | Mobisante, Inc. | 2011 | — |
| +1 | K133833 | Nuvis Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2014 | 3 |
| +2 | K152899 | Philips Lumify Diagnostic Ultrasound System | Philips Healthcare, Inc. | 2015 | 4 |
| +3 | K162549 | Lumify Ultrasound System | Philips Health Care | 2016 | 6 |
| +1 | K151339 | SONON Ultrasound Imaging System (Model: SONON 300C) | Healcerion Co., Ltd. | 2015 | — |
| +4 | K192226 | Lumify Diagnostic Ultrasound System | Philips Health Care | 2019 | 5 |
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 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 4 | 0 |
| 1997 | 7 | 0 |
| 1998 | 4 | 0 |
| 1999 | 10 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 8 | 0 |
| 2021 | 12 | 0 |
| 2022 | 9 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 15 | 2 |
| 2026 | 16 | 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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K070907 | Interson Usb Ultrasound Probe SystemSummary page 1…te Device(s): ~1rbWt ~ i& 19 Jp i AtCESSIOUBER(s1. INTERSON USB Ultrasound Probe System K070907 GE VScan Diagnostic Ultrasound System K092756 Signos Personal Ultrasound… | 2007 |
| * | K092756 | GE Vscan Compact Diagnostic Ultrasound SystemSummary page 1…tCESSIOUBER(s1. INTERSON USB Ultrasound Probe System K070907 GE VScan Diagnostic Ultrasound System K092756 Signos Personal Ultrasound K090505 Intended Use: The MobiUS Ultrasound Imaging Sy… | 2009 |
| * | K090505 | Speq Ultrasound SystemSummary page 1…K070907 GE VScan Diagnostic Ultrasound System K092756 Signos Personal Ultrasound K090505 Intended Use: The MobiUS Ultrasound Imaging System is indicated for ultrasound imaging, measurement and analysis of the human b… | 2009 |
What descends from it? (103)
See all 1034 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 81 ancestors have a recall of any class.
- Of its descendants, K133833 (Philips Ultrasound, Inc., 2014) has gone furthest, with 87 descendants of its own.
- 6 other devices also cite its predicate K070907.
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. 2011, 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 MobiUS Ultrasound Imaging System is indicated for ultrasound imaging, measurement and analysis of the human body for the following clinical applications: fetal/OB, abdominal, cardiac, pelvic, pediatric, musculoskeletal, and peripheral vessel imaging. Its compact size, portability and user interface enable it for use in primary care and special care areas. Diagnostic ultrasound imaging of the human body as follows: Diagnostic ultrasound imaging of the…
Read the full statement (104 words)
The MobiUS Ultrasound Imaging System is indicated for ultrasound imaging, measurement and analysis of the human body for the following clinical applications: fetal/OB, abdominal, cardiac, pelvic, pediatric, musculoskeletal, and peripheral vessel imaging. Its compact size, portability and user interface enable it for use in primary care and special care areas.
Diagnostic ultrasound imaging of the human body as follows:
Diagnostic ultrasound imaging of the human body as follows:
Diagnostic ultrasound imaging of the human body as follows:
Diagnostic ultrasound imaging of the human body as follows:
Diagnostic ultrasound imaging of the human body as follows:
Diagnostic ultrasound Imaging of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102153: Mobius Ultrasound Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102153
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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