510(k) · Cleared
ClearedUgeo PT60A Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Samsung Medison Co., Ltd. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Aug 20, 2013 as substantially equivalent to K122583 (Samsung Medison Co., Ltd., 2012) and 2 other predicates after a 34-day review. Its family tree reaches back 16 generations to 1993. 101 later devices descend from it.
- Decided
- Aug 20, 2013
- Review
- 34 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K924432 (1993). 41 ancestors in all. 101 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 12 generations between
- 3 generations backK103397 Accuvix XG Diagnostic Ultrasound SystemMedison Co., Ltd. · 2011
- 2 generations backK112339 Accuvix A30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
- 1 generation backK122583 Ugeo G60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2012
- This deviceK132228 Ugeo PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- Descendant · cites it directly · 99 of its ownK142466 UGEO PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- Descendant · 2 generations on · 98 of its ownK143264 H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- Descendant · cites it directly · 98 of its ownK133505 Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- Descendant · 2 generations on · 97 of its ownK150478 A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- Descendant · 2 generations on · 96 of its ownK151663 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
Show all 16 generations
- Root · 16 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 15 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 14 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 13 generations backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- 12 generations backK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- 11 generations backK032329 SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc. · 2003
- 10 generations backK052911 Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd. · 2005
- 9 generations backK063580 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006
- 8 generations backK070813 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2007
- 7 generations backK080800 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2008
- 6 generations backK092159 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
- 5 generations backK093849 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- 4 generations backK101455 Eko 7 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- 3 generations backK103397 Accuvix XG Diagnostic Ultrasound SystemMedison Co., Ltd. · 2011
- 2 generations backK112339 Accuvix A30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
- 1 generation backK122583 Ugeo G60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2012
- This deviceK132228 Ugeo PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
Showing 5 of 101 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 101 · See all- K142466UGEO PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · cites it directly99descendants
- K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · 2 generations on98descendants
- K133505Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013 · cites it directly98descendants
- K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015 · 2 generations on97descendants
- K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015 · 2 generations on96descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −15 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −14 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −13 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| −12 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| −11 | K032329 | SA 9900 Plus Diagnostic Ultrasound System | Medison America, Inc. | 2003 | — |
| −10 | K052911 | Accuvix XQ Diagnostic Ultrasound System | Medison Co., Ltd. | 2005 | — |
| −9 | K063580 | Sonoace X8 Diagnostic Ultrasound System | Medison Co., Ltd. | 2006 | — |
| −8 | K070813 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | 2007 | — |
| −7 | K080800 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2008 | — |
| −6 | K092159 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2009 | — |
| −5 | K093849 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| −4 | K101455 | Eko 7 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| −3 | K103397 | Accuvix XG Diagnostic Ultrasound System | Medison Co., Ltd. | 2011 | — |
| −2 | K112339 | Accuvix A30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2011 | — |
| −1 | K122583 | Ugeo G60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2012 | — |
| 0 (this device) | K132228 | Ugeo PT60A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
| +1 | K142466 | UGEO PT60A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| +2 | K143264 | H60 V2.00 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| +1 | K133505 | Sonoace R7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
| +2 | K150478 | A35 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| +2 | K151663 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2017 | 10 | 0 |
| 2018 | 11 | 0 |
| 2019 | 11 | 0 |
| 2020 | 7 | 0 |
| 2021 | 11 | 0 |
| 2022 | 11 | 0 |
| 2023 | 8 | 0 |
| 2024 | 6 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K122583 | Ugeo G60 Diagnostic Ultrasound SystemSummary page 1…ransducer 892.1570 ITX 3. Identitication of the predicate or legally marketed device: - UGEO H-60 Dianostic Ultrasound Sy sten( K 122583) - My Sono U6 Diagnostic UlItrasouind Systcmt K 11338 1) - SonoSite Mvaxx Series: M turbo (K 10 175… | 2012 |
| * | K113381 | Mysono U6 Diagnostic Ultrasound SystemSummary page 1…the predicate or legally marketed device: - UGEO H-60 Dianostic Ultrasound Sy sten( K 122583) - My Sono U6 Diagnostic UlItrasouind Systcmt K 11338 1) - SonoSite Mvaxx Series: M turbo (K 10 1757) 510(k) Summan' / Statement Certification… | 2011 |
| * | K101757 | Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound SystemSummary page 1…UGEO H-60 Dianostic Ultrasound Sy sten( K 122583) - My Sono U6 Diagnostic UlItrasouind Systcmt K 11338 1) - SonoSite Mvaxx Series: M turbo (K 10 1757) 510(k) Summan' / Statement Certification A1TACI If-MENIlI ===… | 2010 |
What descends from it? (101)
See all 1012 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 20 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
- 2 of the 41 ancestors have a recall of any class.
- Of its descendants, K142466 (Samsung Medison Co., Ltd., 2014) has gone furthest, with 99 descendants of its own.
- 3 other devices also cite its predicate K122583.
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. 2013, 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 UGEO PT60A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Small Organ, Adult Cephalic, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult. Cardiac Pediatric and Peripheral vessel. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: (C2-5) Intended Use: Diagnostic…
Read the full statement (121 words)
The UGEO PT60A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal, Abdominal, Small Organ, Adult Cephalic, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult. Cardiac Pediatric and Peripheral vessel.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: (C2-5)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: (C2-8)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: (LN5-12)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: (LS6-15)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: (PN2-4)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132228 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132228: Ugeo PT60A Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132228
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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