510(k) · Cleared
ClearedB-Ultrasound Diagnostic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Contec Medical Systems Co.,Ltd · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on May 3, 2024 as substantially equivalent to K170856 (Contec Medical Systems Co.,Ltd, 2017) after a 228-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- May 3, 2024
- Review
- 228 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K934139 (1995). 19 ancestors in all, the oldest K852159 (1985). No later device cites it as a predicate yet.
- Root · 7 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 6 generations backK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
- 5 generations backK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
- 4 generations backK042540 Philips IU22 Ultrasound SystemPhilips Ultrasound, Inc. · 2004 · Recalled
- 3 generations backK060949 DP-6600 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 2 generations backK081873 Emp-2100 Full Digital Ultrasound Diagnostic DeviceShenzhen Emperor Electronic Technology Co., Ltd. · 2008
- 1 generation backK170856 CMS600P2 B-Ultrasound Diagnostic SystemContec Medical Systems Co.,Ltd · 2017
- This deviceK232895 B-Ultrasound Diagnostic SystemContec Medical Systems Co.,Ltd · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| −6 | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
| −5 | K022824 | Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X… | Tomtec Imaging Systems GmbH | 2002 | — |
| −4 | K042540 | Philips IU22 Ultrasound System | Philips Ultrasound, Inc. | 2004 | 4 |
| −3 | K060949 | DP-6600 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −2 | K081873 | Emp-2100 Full Digital Ultrasound Diagnostic Device | Shenzhen Emperor Electronic Technology Co., Ltd. | 2008 | — |
| −1 | K170856 | CMS600P2 B-Ultrasound Diagnostic System | Contec Medical Systems Co.,Ltd | 2017 | — |
| 0 (this device) | K232895 | B-Ultrasound Diagnostic System | Contec Medical Systems Co.,Ltd | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K170856 | CMS600P2 B-Ultrasound Diagnostic SystemSummary page 7…rray probe √ √ √ √ √ √ 6. Predicate Device Identification Predicate Device: 510(k) Number: K170856 Product Name: CMS600P2 B-Ultrasound Diagnostic System Manufacturer: Contec Medical Systems Co.,Ltd 7. Non-Cl… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 19 ancestors has a recall of any class.
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. 2024, 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?
B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, and small-parts application. The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs (Thyroid, Galactophore, Testis), neonatal cephalic, peripheral vascular, and musculo-skeletal (both conventional and superficial). The device is intended to adult, pregnant woman…
Read the full statement (115 words)
B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, and small-parts application.
The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs (Thyroid, Galactophore, Testis), neonatal cephalic, peripheral vascular, and musculo-skeletal (both conventional and superficial).
The device is intended to adult, pregnant woman, pediatric and neonate.
The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional.
This device is not intended for home use.
Modes of operation include B, M, PWD(PW), B+M, 2B, 4B.
Please refer to the acoustic output declaration for each transducer in 510(K) Summary.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232895 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232895: B-Ultrasound Diagnostic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232895
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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