510(k) · Cleared
ClearedHdi 1000 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atlantis Diagnostics Intl., Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Apr 2, 1998 after a 28-day review. The FDA summary names its predicate without a number.
- Decided
- Apr 2, 1998
- Review
- 28 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (5)
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 | |
| * | — | ATL Ultramark® 9 diagnostic ultrasound system Named without a submission number | |
| * | — | Atlantis Atlas 1.0 system Named without a submission number | |
| * | — | Storz Renaissance A/B Scan Named without a submission number | |
| * | — | HDI 5000 diagnostic ultrasound system Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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.
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?
The HDI 1000 system is intended for opthalmic, fetal (OB/GYN), abdominal, intraoperative (abdominal organs, vasuclar, neurological,) pediatric, small organ, musculoskeletal (conventional, superficial,) neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, and peripheral vessel indications for use. Typical examinations shall include: General abdominal and pelvic studies including organ surveys and retro-peritoneal cavity studies. Study of…
Read the full statement (154 words)
The HDI 1000 system is intended for opthalmic, fetal (OB/GYN), abdominal, intraoperative (abdominal organs, vasuclar, neurological,) pediatric, small organ, musculoskeletal (conventional, superficial,) neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, and peripheral vessel indications for use.
Typical examinations shall include:
General abdominal and pelvic studies including organ surveys and retro-peritoneal cavity studies.
Study of small parts including breasts, penis, testes, thyroid/parathyroid and the abdominal wall.
Pediatric scans of organs.
Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
Monitoring procedures for infertility applications.
First, second and third trimester pregnancy studies.
Prostate, prostate biopsy guidance, and rectal wall studies.
Neonatal cephalic studies.
Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries.
Cardiac studies in adults and children.
Biopsy guidance for tissue or fluid sampling.
Ophthalmic studies of the eye and surrounding structures and studies to obtain blood flow information in the eye and surrounding structures.
Conventional and superficial musculoskeletal studies.
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/K980860 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980860: Hdi 1000 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/K980860
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026