510(k) Report

510(k) · Cleared

Cleared

AMIB7

K990198510(k) TraditionalCleared Jun 29, 1999159-day reviewClass II21 CFR 892.1560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alliance Medical, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Jun 29, 1999 as substantially equivalent to K924126 (Hitachi Medical Systems America, Inc., 1992) and 2 other predicates after a 159-day review. Its family tree reaches back 1 generation to 1990.

Decided
Jun 29, 1999
Review
159 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K900805 (1990). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1993: 1 other ancestor1992: 1 other ancestorK900805 · Aloka 500 Diagnostic Ultrasound Scanning System · Ge Medical Systems Information Technologies · 1990199019921994199619982000
Other ancestors, by generation 1 generation back: 2 other ancestors K900805 · Aloka 500 Diagnostic Ultrasound Scanning System · Ge Medical Systems Information Technologies · 19900
  1. Root · 1 generation backK900805 Aloka 500 Diagnostic Ultrasound Scanning SystemGe Medical Systems Information Technologies · 1990
  2. This deviceK990198 AMIB7Alliance Medical, Inc. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K900805Aloka 500 Diagnostic Ultrasound Scanning SystemGe Medical Systems Information Technologies1990—
0 (this device)K990198AMIB7Alliance Medical, Inc.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199310
FIG. 1 — Lineage of K990198, 1990–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K924126EUB-405
Summary page 1
…sed Echo Imaging System, 892.1560 (CLASS II) COMMON OR USUAL NAME: Ultrasonic Diagnostic System PROPRIETARY NAME: AMIB7 PREVIOUSLY MARKETED DEVICE TO -Hitachi EUB-405 K924126 WHICH SUBSTANTIAL EQUIVALENCE -Aloka SSD-500 K900805 IS BEING CLAIMED: ~Fukada UF-4500 K922208 The AMIB7 is compact, lightweight…
Hitachi Medical Systems America, Inc.1992—
*K900805Aloka 500 Diagnostic Ultrasound Scanning System
Summary page 1
…OR USUAL NAME: Ultrasonic Diagnostic System PROPRIETARY NAME: AMIB7 PREVIOUSLY MARKETED DEVICE TO -Hitachi EUB-405 K924126 WHICH SUBSTANTIAL EQUIVALENCE -Aloka SSD-500 K900805 IS BEING CLAIMED: ~Fukada UF-4500 K922208 The AMIB7 is compact, lightweight and completely self-contained (w12” x h10” x 1207) p…
Ge Medical Systems Information Technologies1990—
*K922208Fukuda Denshi Model UF-4500
Summary page 1
…m PROPRIETARY NAME: AMIB7 PREVIOUSLY MARKETED DEVICE TO -Hitachi EUB-405 K924126 WHICH SUBSTANTIAL EQUIVALENCE -Aloka SSD-500 K900805 IS BEING CLAIMED: ~Fukada UF-4500 K922208 The AMIB7 is compact, lightweight and completely self-contained (w12” x h10” x 1207) portable multipurpose ultrasound scanning s…
Fukuda Denshi USA, Inc.1993—

Also cleared against K924126: 1 other device →

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.

What does this lineage say?

  • None of the 3 ancestors has a recall.
  • 1 other device also cites its predicate K924126.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYO

7in 2025

2007: 202008: 142009: 132010: 152011: 112012: 152013: 172014: 142015: 192016: 102017: 192018: 142019: 132020: 112021: 152022: 52023: 112024: 102025: 72026 (partial year): 10
2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007: 17 days median2008: 36 days median2009: 79 days median2010: 113 days median2011: 69 days median2012: 68 days median2013: 50 days median2014: 63 days median2015: 46 days median2016: 36 days median2017: 72 days median2018: 56 days median2019: 59 days median2020: 57 days median2021: 64 days median2022: 190 days median2023: 177 days median2024: 220 days median2025: 171 days median2026 (partial year): 139 days median
2007high 220 (2024) · low 17 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYO

1in 2022

2007: 42008: 52009: 92010: 82012: 22013: 32014: 22015: 12018: 12019: 12021: 112022: 12026 (partial year): 1
2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007: 392008: 202009: 272010: 202011: 582012: 782013: 4362014: 3042015: 2682016: 2542017: 2382018: 3682019: 5372020: 4982021: 6172022: 5112023: 5272024: 6402025: 485
2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072017439
20081436520
20091379927
201015113820
20111169058
20121568278
201317503436
201414632304
201519461268
201610360254
201719720238
201814561368
201913591537
202011570498
2021156411617
202251901511
2023111770527
2024102200640
202571710485
2026101391—

What is it indicated for?

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K924126

1 other device cites the same predicate.

  • K961974FG-36UX, Ultrasound Upper GI FiberscopePentax Precision Instrument Corp. · 19972 recalls

More from Alliance Medical, Inc.

11 FDA decisions under this applicant name. See the company

  • K051438Vanguard Reprocessed Compression Garments (Hill-Rom)Alliance Medical, Inc. · 20061 recall
  • K050518Reprocessed Phacoemuisification TipsAlliance Medical, Inc. · 2005
  • K030187Reprocessed Electrophysiology CatheterAlliance Medical, Inc. · 200328 recalls
  • K021654Reprocessed Compression SleeveAlliance Medical, Inc. · 2003
  • K012634Reprocessed External Fixation DeviceAlliance Medical, Inc. · 2002

Recent decisions in IYO

The IYO category page

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https://510kreport.com/device/K990198 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990198: AMIB7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990198

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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