510(k) · Cleared
ClearedImago C21 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Saset (Chengdu), Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Apr 30, 2009 as substantially equivalent to K014116 (Sonosite,Inc., 2001) and 1 other predicate after a 111-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Apr 30, 2009
- Review
- 111 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K935595 (1995). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 2 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 1 generation backK020630 Ultrasonix Ergosonix 500 Ultrasound ScannerUltrasonix Medical Corporation · 2002
- This deviceK090059 Imago C21 Diagnostic Ultrasound SystemSaset (Chengdu), Inc. · 2009
- Descendant · cites it directly · 0 of its ownK150002 iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −2 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −1 | K020630 | Ultrasonix Ergosonix 500 Ultrasound Scanner | Ultrasonix Medical Corporation | 2002 | — |
| 0 (this device) | K090059 | Imago C21 Diagnostic Ultrasound System | Saset (Chengdu), Inc. | 2009 | — |
| +1 | K150002 | iNSIGHT Color Doppler Ultrasound System | Saset (Chengdu), Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (2)
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 |
|---|---|---|---|
| * | K014116 | Hand-Carried Ultrasound SystemSummary page 2…Chengdu, Sichuan, China 2.4 Classification: Class II 2.5 Predicate Device: Sonosite Hand-Carried Ultrasound system (k0 14116) ES500 system (k020630) 2.6 Reason for submission: New product. 3.0 Device Description The iMago c21… | 2001 |
| * | K020630 | Ultrasonix Ergosonix 500 Ultrasound ScannerSummary page 2…ichuan, China 2.4 Classification: Class II 2.5 Predicate Device: Sonosite Hand-Carried Ultrasound system (k0 14116) ES500 system (k020630) 2.6 Reason for submission: New product. 3.0 Device Description The iMago c21 Diagnostic Ultrasound System is… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150002 | iNSIGHT Color Doppler Ultrasound System | 2015 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K150002 (Saset (Chengdu), Inc., 2015) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K014116.
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. 2009, 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 iMago c21 medical ultrasound system is intended for visualization of internal organs and for medical diagnostic purposes only. The main applications are: General radiology, Abdominal (excluding fetal Doppler), Vascular, OB/GYN, Urology, Breast, Superficial Organ (Small Parts), Musculoskeletal, and Cardiology. Each application includes a set of exams, including the specific measurements, reports, pictograms, annotations and system presets.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090059 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090059: Imago C21 Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090059
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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