510(k) Report

510(k) · Cleared

Cleared

Aloka SSD-1700 Diagnostic Ultrasound System

K963616510(k) TraditionalCleared Apr 3, 1997205-day reviewClass II21 CFR 892.1550

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

Aloka Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Apr 3, 1997 after a 205-day review. The FDA summary names its predicate without a number. 346 later devices descend from it.

Decided
Apr 3, 1997
Review
205 days
Class
Class II
Product code
IYN
Recalls
None
Predicates
0

346 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared1998: 2 descendants cleared1997: 1 descendant cleared1999: 1 descendant cleared2004: 3 descendants cleared2011: 12 descendants cleared2013: 13 descendants cleared2006: 3 descendants cleared2007: 5 descendants cleared2001: 1 descendant cleared2002: 1 descendant cleared2009: 6 descendants cleared2010: 9 descendants cleared2008: 6 descendants cleared2016: 18 descendants cleared2014: 12 descendants cleared2012: 12 descendants cleared2020: 23 descendants cleared2019: 31 descendants cleared2018: 25 descendants cleared2015: 17 descendants cleared2017: 35 descendants cleared2023: 18 descendants cleared2024: 19 descendants cleared2025: 22 descendants cleared2026: 12 descendants cleared2022: 19 descendants cleared2021: 19 descendants cleared1995200020052010201520202025
  1. This deviceK963616 Aloka SSD-1700 Diagnostic Ultrasound SystemAloka Co., Ltd. · 1997
  2. Descendant · cites it directly · 342 of its ownK992663 Aloka SSD-5500 Diagnostic Ultrasound SystemAloka Co., Ltd. · 1999
  3. Descendant · 2 generations on · 207 of its ownK012080 SSD-5000 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2001
  4. Descendant · 2 generations on · 191 of its ownK060949 DP-6600 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
  5. Descendant · 3 generations on · 189 of its ownK063500 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
  6. Descendant · 3 generations on · 188 of its ownK072164 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007

Showing 5 of 346 descendants. See all descendants

Descendants cleared per year

1997: 11998: 21999: 12001: 12002: 12003: 12004: 32006: 32007: 52008: 62009: 62010: 92011: 122012: 122013: 132014: 122015: 172016: 182017: 352018: 252019: 312020: 232021: 192022: 192023: 182024: 192025: 222026: 12
1997high 35 (2017) · low 0 (2000)2026

Most influential descendants

Showing 5 of 346 · See all
  • K992663Aloka SSD-5500 Diagnostic Ultrasound SystemAloka Co., Ltd. · 1999 · cites it directly342descendants
  • K012080SSD-5000 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2001 · 2 generations on207descendants
  • K060949DP-6600 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · 2 generations on191descendants
  • K063500DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · 3 generations on189descendants
  • K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · 3 generations on188descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K963616Aloka SSD-1700 Diagnostic Ultrasound SystemAloka Co., Ltd.1997—
+1K992663Aloka SSD-5500 Diagnostic Ultrasound SystemAloka Co., Ltd.1999—
+2K012080SSD-5000 Diagnostic Ultrasound SystemAloka Co., Ltd.2001—
+2K060949DP-6600 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006—
+3K063500DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006—
+3K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199820
199910
200110
200210
200310
200430
200630
200750
200860
200960
201090
2011120
2012120
2013130
2014120
2015170
2016180
2017350
2018250
2019310
2020230
2021190
2022190
2023180
2024190
2025220
2026120
FIG. 1 — Lineage of K963616, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 IYN? 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 IYN device

  1. #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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? (1)

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
*—Aloka Omniview diagnostic ultrasound system and transducers
Named without a submission number
—

What descends from it? (346)

See all 346

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K992663Aloka SSD-5500 Diagnostic Ultrasound SystemAloka Co., Ltd.1999342
K032875Aloka Model SSD-5500 V6.0 Ultrasound SystemAloka Co. Ltd USA2003124
K972973Perception Inc. GPS-Tuv Diagnostic Ultrasound SystemPerception, Inc.19972
K981834Perception Inc, GPS-6TBMD Diagnostic Ultrasound SystemPerception, Inc.19980
K974880Perception GPS-RST Diagnostic Ultrasound SystemPerception, Inc.19980

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, K992663 (Aloka Co., Ltd., 1999) has gone furthest, with 342 descendants of its own.

How does its category compare?

All IYN devices

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

FDA decisions per year · IYN

57in 2025

2007: 132008: 252009: 182010: 292011: 392012: 432013: 512014: 562015: 542016: 602017: 642018: 592019: 472020: 572021: 462022: 532023: 442024: 502025: 572026 (partial year): 44
2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007: 26 days median2008: 18 days median2009: 29 days median2010: 67 days median2011: 46 days median2012: 37 days median2013: 60 days median2014: 39 days median2015: 55 days median2016: 56 days median2017: 83 days median2018: 85 days median2019: 79 days median2020: 72 days median2021: 105 days median2022: 105 days median2023: 115 days median2024: 119 days median2025: 124 days median2026 (partial year): 107 days median
2007high 124 (2025) · low 18 (2008)2026

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

Recalls per year · IYN

10in 2025

2007: 162008: 122009: 82010: 102011: 82012: 32013: 82014: 22015: 32016: 22018: 72020: 42021: 82022: 102023: 42024: 12025: 102026 (partial year): 2, 1 Class I
2007high 16 (2007) · low 0 (2017)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · IYN

610in 2025

2007: 32008: 22009: 92010: 172011: 182012: 202013: 182014: 482015: 1162016: 1452017: 1462018: 852019: 592020: 672021: 2132022: 1862023: 2292024: 2662025: 610
2007high 610 (2025) · low 2 (2008)2025

MAUDE reports naming product code IYN, 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
20071326163
20082518122
2009182989
201029671017
20113946818
20124337320
20135160818
20145639248
201554553116
201660562145
201764830146
20185985785
20194779059
20205772467
2021461058213
20225310510186
2023441154229
2024501191266
20255712410610
2026441072 (1)—

What is it indicated for?

The Aloka SSD-1700, like other marketed diagnostic ultrasound systems, is indicated for imaging body structures to aid in the diagnosis of disease or abnormality.

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

More from Aloka Co., Ltd.

39 FDA decisions under this applicant name. See the company

  • K111227Aloka SSD-3500 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2011
  • K110207Aloka Prousound F75 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2011
  • K093488Aloka Prosound Alpha 6 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2009
  • K083254Aloka Prousound 2 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2008
  • K081843Ultrasound Data Analysis System, Model Das-RS1Aloka Co., Ltd. · 2008

Recent decisions in IYN

The IYN category page

  • K261585Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K263150V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10…Samsung Medison Co., Ltd. · 2026
  • K261617Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K261933Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary care Diagnostics, LLC · 2026
  • K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · 2026

https://510kreport.com/device/K963616 · printed Nov 5, 2026

Cite this page

510(k) Report. “K963616: Aloka SSD-1700 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/K963616

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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