510(k) · Cleared
ClearedInterson Usb Ultrasound Probe System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Regulatory Management Services · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Apr 17, 2007 as substantially equivalent to K992505 (Teratech Corp., 1999) after a 15-day review. Its family tree reaches back 2 generations to 1991. 2 of the 111 devices in its family, counting itself, have a Class I recall. 106 later devices descend from it.
- Decided
- Apr 17, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K903603 (1991). 4 ancestors in all. 106 later devices descend from it, 7 citing it directly. 2 of the 111 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK903603 Ultramark 9 Ultrasound System (UM 9)Advanced Technology Laboratories, Inc. · 1991
- 1 generation backK992505 Teratech, Model 2000 Imaging ImagingTeratech Corp. · 1999
- This deviceK070907 Interson Usb Ultrasound Probe SystemRegulatory Management Services · 2007
- Descendant · cites it directly · 103 of its ownK102153 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 · 2 generations on · 33 of its ownK151339 SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd. · 2015
Showing 5 of 106 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 106 · See all- K102153Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011 · cites it directly103descendants
- 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 · 2 generations on33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K903603 | Ultramark 9 Ultrasound System (UM 9) | Advanced Technology Laboratories, Inc. | 1991 | — |
| −1 | K992505 | Teratech, Model 2000 Imaging Imaging | Teratech Corp. | 1999 | — |
| 0 (this device) | K070907 | Interson Usb Ultrasound Probe System | Regulatory Management Services | 2007 | — |
| +1 | 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 |
| +2 | K151339 | SONON Ultrasound Imaging System (Model: SONON 300C) | Healcerion Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 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? (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 |
|---|---|---|---|
| * | K992505 | Teratech, Model 2000 Imaging ImagingSummary page 3…are provided by utilizing a technology called digital dynamic receive focusing. The same clinical uses were cleared for the predicate device(s), Teratech, Terason 2000, K992505 5) Intended Use: * Fetal - OB/GYN * Abdominal * Small Organs (breast, thyroid, testicle) · P… | 1999 |
What descends from it? (106)
See all 1067 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102153 | Mobius Ultrasound Imaging System | 2011 | 103 |
| K133833 | Nuvis Diagnostic Ultrasound System | 2014 | 87 |
| K163443 | Interson USB Ultrasound System | 2017 | 3 |
| K134014 | Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe) | 2014 | 3 |
| K192170 | VistaScan USB Ultrasound Imaging System | 2020 | 0 |
| K160792 | Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound | 2016 | 0 |
| K080049 | Vascuview Ultrasound System | 2008 | 0 |
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 3 companies; a new generation was cleared every 8.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K102153 (Mobisante, Inc., 2011) has gone furthest, with 103 descendants of its own.
- 1 other device also cites its predicate K992505.
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. 2007, 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?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070907 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070907: Interson Usb Ultrasound Probe System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070907
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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