510(k) · Cleared
ClearedCombison 530 Diagnostic Ultrasound Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medison America, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Feb 19, 1997 after a 1,086-day review. The FDA summary names its predicate without a number. 737 later devices descend from it.
- Decided
- Feb 19, 1997
- Review
- 1,086 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
737 later devices descend from it, 3 citing it directly.
- This deviceK940942 Combison 530 Diagnostic Ultrasound ScannerMedison America, Inc. · 1997
- Descendant · cites it directly · 677 of its ownK034003 Hdi 5000 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 676 of its ownK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- Descendant · 3 generations on · 584 of its ownK080935 Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008
- Descendant · 3 generations on · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- Descendant · 4 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
Showing 5 of 737 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 737 · See all- K034003Hdi 5000 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2004 · cites it directly677descendants
- K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · 2 generations on676descendants
- K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008 · 3 generations on584descendants
- K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · 3 generations on582descendants
- K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 4 generations on569descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940942 | Combison 530 Diagnostic Ultrasound Scanner | Medison America, Inc. | 1997 | — |
| +1 | K034003 | Hdi 5000 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2004 | 4 |
| +2 | K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 3 |
| +3 | K080935 | Sonix MDP Ultrasound Scanner | Ultrasonix Medical Corporation | 2008 | — |
| +3 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| +4 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 8 | 0 |
| 2009 | 9 | 0 |
| 2010 | 14 | 0 |
| 2011 | 22 | 0 |
| 2012 | 30 | 0 |
| 2013 | 30 | 0 |
| 2014 | 41 | 0 |
| 2015 | 38 | 0 |
| 2016 | 48 | 0 |
| 2017 | 54 | 0 |
| 2018 | 54 | 0 |
| 2019 | 40 | 0 |
| 2020 | 57 | 0 |
| 2021 | 42 | 0 |
| 2022 | 48 | 0 |
| 2023 | 42 | 0 |
| 2024 | 48 | 0 |
| 2025 | 54 | 0 |
| 2026 | 35 | 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? (13)
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 |
|---|---|---|---|
| * | — | Kretztechnik Diagnostic Ultrasound Scanner COMBISON 330 Named without a submission number | |
| * | — | Toshiba Diagnostic Ultrasound Scanner SSH-140A Named without a submission number | |
| * | — | Siemens Diagnostic Ultrasound Scanner SONOLINE SI-450 Named without a submission number | |
| * | — | Kretztechnik Sector Transducer AWP 3.5/A Named without a submission number | |
| * | — | Kretztechnik Sector Transducer AW 4/5 B/A Named without a submission number | |
| * | — | Kretztechnik Sector Transducer NW 17.5 B/A Named without a submission number | |
| * | — | Kretztechnik Transrectal Transducer VRW 177 AK/A Named without a submission number | |
| * | — | Kretztechnik Transrectal Transducer IRW 177 AK/A Named without a submission number | |
| * | — | Kretztechnik Transvaginal/Urologic Transducer WIW 17.5 AP/A Named without a submission number | |
| * | — | Kretztechnik Transvaginal Transducer IR 15/7 BG/A Named without a submission number | |
| * | — | Acoustic Imaging Convex Sector Transducer CLA 3.5 Named without a submission number | |
| * | — | Acoustic Imaging Convex Sector Transducer CLA 5.0 Named without a submission number | |
| * | — | Acoustic Imaging Linear Array Transducer MLA 7.5 Named without a submission number |
What descends from it? (737)
See all 7373 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?
- Of its descendants, K034003 (Philips Ultrasound, Inc., 2004) has gone furthest, with 677 descendants of its own.
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.
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?
This device is intended for use with the listed transducers for the transcutaneous, transrectal, and transvaginal imaging of organs or structures as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria; and in obstetric patients for the transcutaneous, or transvaginal imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing…
Read the full statement (919 words)
This device is intended for use with the listed transducers for the transcutaneous, transrectal, and transvaginal imaging of organs or structures as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria; and in obstetric patients for the transcutaneous, or transvaginal imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity.
This device is intended for use with the COMBISON® 530 system for the transcutaneous imaging of intraabdominal organs and structures including the gastrointestinal tract, kidney, bladder, etc. as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria; and in obstetric patients for the transcutaneous imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity.
This device is intended for use with the COMBISON® 530 system for the transcutaneous imaging of intraabdominal organs and structures including the gastrointestinal tract, kidney, bladder, etc. as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria; and in obstetric patients for the transcutaneous imaging of the fetus and uterine structures including -the performance of fetal measurements for the purpose of assessing fetal growth and maturity.
This device is intended for use with the COMBISON® 530 system for the transcutaneous imaging of intraabdominal organs and structures including the gastrointestinal tract, kidney, bladder, etc. as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria; and in obstetric patients for the transcutaneous imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity.
This device is intended for use with the COMBISON* 530 system for the transcutaneous imaging of intraabdominal organs and structures including the gastrointestinal tract, kidney, bladder, etc. as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria; and in obstetric patients for the transcutaneous imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity.
This device is intended for use with the COMBISON® 530 system for the transcutaneous imaging of intraabdominal organs and structures including the gastrointestinal tract, kidney, bladder, etc. as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria; and in obstetric patients for the transcutaneous imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity.
This device is intended for use with the COMBISON* 530 system for the transcutaneous imaging of intraabdominal organs and structures including the gastrointestinal tract, kidney, bladder, etc. as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria; and in obstetric patients for the transcutaneous imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity.
This device is intended for use with the COMBISON* 530 system for the transcutaneous imaging of peripheral vessels and small organs including breast, thyroid, testes, etc. as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria.
This device is intended for use with the COMBISON® 530 system for the transrectal imaging of the rectum and surrounding organs and structures including the rectum wall, prostate gland, etc. as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria. An approved biopsy attachement is available for use with this transducer.
This device is intended for use with the COMBISON* 530 system in the imaging of the fetus and uterine structures utilizing the transvaginal approach as an aid in the diagnosis of obstetrical and gynecological conditions including the performance of fetal measurements for the purpose of assessing fetal growth and maturity. An approved biopsy attachement is available for use with this transducer.
This device is intended for use with the COMBISON* 530 system in the imaging of the fetus and uterine structures utilizing the transvaginal approach as an aid in the diagnosis of obstetrical and gynecological conditions including the performance of fetal measurements for the purpose of assessing fetal growth and maturity. An approved biopsy attachement is available for use with this transducer.
This device is intended for use with the COMBISON* 530 system for the transcutaneous imaging of intraabdominal organs and structures including the gastrointestinal tract, kidney, bladder, etc. as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria; and in obstetric patients for the transcutaneous imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity.
This device is intended for use with the COMBISON® 530 system for the transcutaneous imaging of intraabdominal organs and structures including the gastrointestinal tract, kidney, bladder, etc. as an aid in the detection and assessment of physical and functional abnormalities using’ established diagnostic criteria; and in obstetric patients for the transcutaneous imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity.
This device is intended for use with the COMBISON* 530 system for the transcutaneous imaging of peripheral vessels and small organs including breast, thyroid, testes, etc. as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K940942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K940942: Combison 530 Diagnostic Ultrasound Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940942
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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