510(k) · Cleared
ClearedAplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon Medical Systems Corporation · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Sep 12, 2024 as substantially equivalent to K223017 (Canon Medical Systems Corporation, 2023) after a 101-day review. Its family tree reaches back 28 generations to 1995. 7 of the 395 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 12, 2024
- Review
- 101 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 28 generations to K935595 (1995). 394 ancestors in all, the oldest K844472 (1985). No later device cites it as a predicate yet. 7 of the 395 devices in this family, counting this one, have a Class I recall.
- Root · 28 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 24 generations between
- 3 generations backK201972 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation · 2020
- 2 generations backK212333 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation · 2022 · Recalled
- 1 generation backK223017 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation · 2023
- This deviceK241582 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0…Canon Medical Systems Corporation · 2024
Show all 28 generations
- Root · 28 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 27 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 26 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 25 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 24 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 23 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 22 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 21 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 20 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 19 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 18 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 17 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 16 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 15 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 14 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 13 generations backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- 12 generations backK131267 Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013
- 11 generations backK132913 Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare · 2013
- 10 generations backK141639 Voluson S6, Voluson S8GE Healthcare · 2014
- 9 generations backK143452 Logiq P9, Logiq P7GE Healthcare · 2015
- 8 generations backK152195 Logiq S8GE Healthcare · 2015
- 7 generations backK170445 Logiq S8GE Healthcare · 2017 · Recalled
- 6 generations backK173021 Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine · 2018
- 5 generations backK180572 AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30…Supersonic Imagine · 2018
- 4 generations backK191467 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation · 2019
- 3 generations backK201972 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation · 2020
- 2 generations backK212333 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation · 2022 · Recalled
- 1 generation backK223017 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation · 2023
- This deviceK241582 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0…Canon Medical Systems Corporation · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −28 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −27 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −26 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −25 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −24 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −23 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −22 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −21 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −20 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −19 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −18 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −17 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −16 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −15 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −14 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −13 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| −12 | K131267 | Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 | GE Healthcare | 2013 | — |
| −11 | K132913 | Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 | GE Healthcare | 2013 | — |
| −10 | K141639 | Voluson S6, Voluson S8 | GE Healthcare | 2014 | — |
| −9 | K143452 | Logiq P9, Logiq P7 | GE Healthcare | 2015 | — |
| −8 | K152195 | Logiq S8 | GE Healthcare | 2015 | — |
| −7 | K170445 | Logiq S8 | GE Healthcare | 2017 | 1 |
| −6 | K173021 | Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems | Supersonic Imagine | 2018 | — |
| −5 | K180572 | AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach… | Supersonic Imagine | 2018 | — |
| −4 | K191467 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 | Canon Medical Systems Corporation | 2019 | — |
| −3 | K201972 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1 | Canon Medical Systems Corporation | 2020 | — |
| −2 | K212333 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 | Canon Medical Systems Corporation | 2022 | 1 |
| −1 | K223017 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 | Canon Medical Systems Corporation | 2023 | — |
| 0 (this device) | K241582 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900… | Canon Medical Systems Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 11 | 0 |
| 1996 | 7 | 1 |
| 1997 | 12 | 0 |
| 1998 | 19 | 3 |
| 1999 | 21 | 0 |
| 2000 | 18 | 1 |
| 2001 | 20 | 0 |
| 2002 | 27 | 0 |
| 2003 | 25 | 0 |
| 2004 | 20 | 1 |
| 2005 | 21 | 0 |
| 2006 | 17 | 0 |
| 2007 | 16 | 1 |
| 2008 | 19 | 0 |
| 2009 | 12 | 0 |
| 2010 | 13 | 0 |
| 2011 | 10 | 0 |
| 2012 | 15 | 0 |
| 2013 | 12 | 0 |
| 2014 | 11 | 0 |
| 2015 | 5 | 0 |
| 2016 | 6 | 0 |
| 2017 | 7 | 0 |
| 2018 | 3 | 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.
7 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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 |
|---|---|---|---|
| * | K223017 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Summary page 6…EVICE Product Marketed by 510(k) Number Clearance Date Aplio i900/i800/i700 Diagnostic Canon Medical K223017 March 31, 2023 Ultrasound System, Software Systems USA, Inc. V7.0 9. REASON FOR SUBMISSION… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (7 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.
- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · 10 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 10 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 10 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 10 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 10 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 10 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
- K070106VV Fluoro 3DBrainlab AG · 2007 · 11 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- The line of descent spans 29 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 110 of the 394 ancestors have a recall of any class; 7 have a Class I recall.
- 1 other device also cites its predicate K223017.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
The Diagnostic Ultrasound System Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-AI700 are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs (thyroid, breast and testicle), trans-vaginal, trans-rectal, neonatal…
Read the full statement (144 words)
The Diagnostic Ultrasound System Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-AI700 are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs (thyroid, breast and testicle), trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and Thoracic/Pleural. This system provides high-quality ultrasound images in the following modes B mode, M mode, Continuous Wave, Color Doppler, Pulsed Wave Doppler , Power Doppler and Combination Doppler, as well as Speckle-tracking, Tissue Harmonic Imaging, Combined Modes, Shear wave, Elastography, and Acoustic attenuation mapping. This system is suitable for use in hospital and clinical settings by physicians or legally qualified persons who have received the appropriate training.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241582 · printed Nov 4, 2026
Cite this page
510(k) Report. “K241582: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K241582
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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