510(k) Report

510(k) · Cleared

Cleared

Remote Fetal Medicine Ultrasound System

K000443510(k) TraditionalCleared Apr 24, 200074-day reviewClass II21 CFR 892.2050

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

R4 Telemedicine, Inc. · LLZ System, Image Processing, Radiological

Cleared on Apr 24, 2000 after a 74-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Apr 24, 2000
Review
74 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2005: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK000443 Remote Fetal Medicine Ultrasound SystemR4 Telemedicine, Inc. · 2000
  2. Descendant · cites it directly · 2 of its ownK022877 Observer Ultrasound Reporting and Imaging SystemVision Chips, Inc. · 2003
  3. Descendant · cites it directly · 1 of its ownK051639 AS-Obgyn Information System; as-Emr SystemAs Software, Inc. · 2005 · Recalled
  4. Descendant · 2 generations on · 0 of its ownK260205 AS Software Version AseraAS Software, LLC · 2026

Most influential descendants

Showing 3 of 3 · See all
  • K022877Observer Ultrasound Reporting and Imaging SystemVision Chips, Inc. · 2003 · cites it directly2descendants
  • K051639AS-Obgyn Information System; as-Emr SystemAs Software, Inc. · 2005 · cites it directly1descendant
  • K260205AS Software Version AseraAS Software, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000443Remote Fetal Medicine Ultrasound SystemR4 Telemedicine, Inc.2000—
+1K022877Observer Ultrasound Reporting and Imaging SystemVision Chips, Inc.2003—
+1K051639AS-Obgyn Information System; as-Emr SystemAs Software, Inc.20051
+2K260205AS Software Version AseraAS Software, LLC2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
202610
FIG. 1 — Lineage of K000443, 2000–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LLZ? 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 LLZ device

  1. #1 K230955 syngo Application Softwarescore 21.5 · 11 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K022877Observer Ultrasound Reporting and Imaging SystemVision Chips, Inc.20032
K051639AS-Obgyn Information System; as-Emr SystemAs Software, Inc.20051

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, K022877 (Vision Chips, Inc., 2003) has gone furthest, with 2 descendants of its own.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

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

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

Recent decisions in LLZ

The LLZ category page

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  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K000443 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000443: Remote Fetal Medicine Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000443

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026