510(k) Report

510(k) · Cleared

Cleared

Sonopsy LA System

K980423510(k) TraditionalCleared Aug 7, 1998185-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

Neovision Corp. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Aug 7, 1998 after a 185-day review. The FDA summary names its predicate without a number. 1 later device descends from it.

Decided
Aug 7, 1998
Review
185 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared1995200020052010201520202025
  1. This deviceK980423 Sonopsy LA SystemNeovision Corp. · 1998
  2. Descendant · cites it directly · 0 of its ownK013886 Avera Model Dei System (Diffractive Energy Imaging System)Advanced Diagnostics, Inc. · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K013886Avera Model Dei System (Diffractive Energy Imaging System)Advanced Diagnostics, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K980423Sonopsy LA SystemNeovision Corp.1998—
+1K013886Avera Model Dei System (Diffractive Energy Imaging System)Advanced Diagnostics, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K980423, 1998–2002Source: 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*—NeoVision Sonopsy System
Named without a submission number
—
*—Siemens SONOLINE Prima Digital Ultrasound System
Named without a submission number
—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K013886Avera Model Dei System (Diffractive Energy Imaging System)Advanced Diagnostics, Inc.20020

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, K013886 (Advanced Diagnostics, Inc., 2002) has gone furthest, with 0 descendants of its own.

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?

The intended use of the Sonopsy LA System is as a diagnostic ultrasound imaging system of the human body as follows: Mode of Operation: B-Mode, Clinical Application: Small Organ (breast, thyroid, testes) Abdominal The Sonopsy LA System is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning annular array transducer. Automatic scanning obtains multiple, sequential…

Read the full statement (134 words)

The intended use of the Sonopsy LA System is as a diagnostic ultrasound imaging system of the human body as follows:

Mode of Operation: B-Mode,

Clinical Application: Small Organ (breast, thyroid, testes)

Abdominal

The Sonopsy LA System is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning annular array transducer. Automatic scanning obtains multiple, sequential two-dimensional images which can be compiled into a three-dimensional data set for viewing in three planes. The system is intended to be used for the real-time ultrasonic guidance of needle aspiration and biopsy procedures of breast lesions.

The Sonopsy LA System is indicated for the diagnostic ultrasound B-mode imaging of small organs (breast, thyroid, testes) and the abdomen when used with the hand-held linear array scanhead.

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

More from Neovision Corp.

2 FDA decisions under this applicant name. See the company

  • K951999Holopsy SystemNeovision Corp. · 1996

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https://510kreport.com/device/K980423 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980423: Sonopsy LA System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980423

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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