510(k) · Cleared
ClearedLevel 10 Hdi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Technology Laboratories, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Mar 26, 1997 after a 344-day review. The FDA summary names its predicate without a number. 3 of the 1,078 devices in its family, counting itself, have a Class I recall. 1,077 later devices descend from it.
- Decided
- Mar 26, 1997
- Review
- 344 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
1,077 later devices descend from it, 16 citing it directly. 3 of the 1,078 devices in this family, counting this one, have a Class I recall.
- This deviceK961459 Level 10 HdiAdvanced Technology Laboratories, 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 1,077 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 1,077 · 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) | K961459 | Level 10 Hdi | Advanced Technology Laboratories, 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 |
|---|---|---|
| 1998 | 5 | 0 |
| 1999 | 12 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 3 | 0 |
| 2003 | 9 | 0 |
| 2004 | 7 | 0 |
| 2005 | 9 | 0 |
| 2006 | 9 | 0 |
| 2007 | 14 | 0 |
| 2008 | 17 | 0 |
| 2009 | 24 | 0 |
| 2010 | 19 | 0 |
| 2011 | 25 | 0 |
| 2012 | 41 | 0 |
| 2013 | 41 | 0 |
| 2014 | 53 | 0 |
| 2015 | 62 | 0 |
| 2016 | 68 | 0 |
| 2017 | 74 | 0 |
| 2018 | 68 | 0 |
| 2019 | 51 | 0 |
| 2020 | 76 | 1 |
| 2021 | 56 | 0 |
| 2022 | 59 | 0 |
| 2023 | 62 | 0 |
| 2024 | 63 | 0 |
| 2025 | 88 | 2 |
| 2026 | 54 | 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.
3 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 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 |
|---|---|---|---|
| * | — | ATL HDI 3000 diagnostic ultrasound system Named without a submission number | |
| * | — | Storz Renaissance A/B Scan Named without a submission number |
What descends from it? (1,077)
See all 1,07716 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K034003 | Hdi 5000 Diagnostic Ultrasound System | 2004 | 677 |
| K030455 | Boris Platform Diagnostic Ultrasound System | 2003 | 535 |
| K014116 | Hand-Carried Ultrasound System | 2001 | 433 |
| K981397 | Harmonic Imaging and Flash Echo Imaging Function for the Diagnostic Ultrasound System… | 1998 | 403 |
| K974269 | SA8800 Diagnostic Ultrasound System and Transducers, | 1998 | 215 |
| K990248 | Dicom Image Manager, Model 3-D Visualization Option | 1999 | 213 |
| K981510 | Sonoace 6000/ Ultramark 400 | 1998 | 212 |
| K021628 | Sonosite Hand-Caried Untrasound System (Powerseries) | 2002 | 124 |
| K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | 2001 | 59 |
| K031347 | Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8 | 2003 | 44 |
Has anything in its family been recalled? (3 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.
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 11 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?
Level 10 HDI is intended for cardiac, peripheral vascular, fetal imaging and other, and ophthalmic intended uses as defined FDA guidance documents. Typical examinations using Level 10 HDI are: General abdominal and pelvic studies including organ surveys, blood flow assessment, and retroperitoneal cavity studies. Study of small parts and superficial structures including breasts, shoulders, thyroid/parathyroid, and the abdominal wall. Pediatric scans of…
Read the full statement (214 words)
Level 10 HDI is intended for cardiac, peripheral vascular, fetal imaging and other, and ophthalmic intended uses as defined FDA guidance documents.
Typical examinations using Level 10 HDI are:
General abdominal and pelvic studies including organ surveys, blood flow assessment, and retroperitoneal cavity studies.
Study of small parts and superficial structures including breasts, shoulders, thyroid/parathyroid, and the abdominal wall.
Pediatric scans of organs, superficial, and bony structures.
Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
Monitoring procedures for infertility studies (other than in vitro fertilization).
First, second and third trimester pregnancy studies.
Prostate, prostate biopsy guidance, and rectal wall studies.
Neonatal head studies.
Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries.
Cardiac studies in adults and children.
Monitoring of cardiac function during procedures using transesophageal echocardiography.
Biopsy guidance for tissue or fluid sampling.
Assessment of cardiac muscle, coronary arteries and great vessels during cardiac surgery
Study of myocardial function in adults
Study of eye anatomy including blood flow in retinal vessels and branches
Study of the esophagué, stomach, biliary sytem, pancreas and gastrointestinal tract using endoscopic probe
Study of abdominal and pelvic organs and masses using laparoscopic probe
Examination of organs, masses and vessels during surgical procedures
Study of muscles, ligaments, nerve bundles and connective tissue
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/K961459 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961459: Level 10 Hdi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961459
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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