510(k) Report

510(k) · Cleared

Cleared

MiPACS HTML5 Web Viewer

K212984510(k) TraditionalCleared Nov 12, 202156-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

Lead Technologies, Inc. · LLZ System, Image Processing, Radiological

Cleared on Nov 12, 2021 as substantially equivalent to K182572 (Meddiff Technologies Pvt., Ltd., 2019) after a 56-day review. Its family tree reaches back 1 generation to 2019. 1 later device descends from it.

Decided
Nov 12, 2021
Review
56 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K182572 (2019). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2026: 1 descendant clearedK182572 · InstaRISPACS / InstaZFP / InstaMobi v5.0 · Meddiff Technologies Pvt., Ltd. · 2019201620182020202220242026
Descendants, by generation 1 generation forward: 1 descendant K182572 · InstaRISPACS / InstaZFP / InstaMobi v5.0 · Meddiff Technologies Pvt., Ltd. · 20190
  1. Root · 1 generation backK182572 InstaRISPACS / InstaZFP / InstaMobi v5.0Meddiff Technologies Pvt., Ltd. · 2019
  2. This deviceK212984 MiPACS HTML5 Web ViewerLead Technologies, Inc. · 2021
  3. Descendant · cites it directly · 0 of its ownK260231 MiPACS V5 (1.0.0)Apryse Software Corp · 2026

Most influential descendants

Showing 1 of 1 · See all
  • K260231MiPACS V5 (1.0.0)Apryse Software Corp · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K182572InstaRISPACS / InstaZFP / InstaMobi v5.0Meddiff Technologies Pvt., Ltd.2019—
0 (this device)K212984MiPACS HTML5 Web ViewerLead Technologies, Inc.2021—
+1K260231MiPACS V5 (1.0.0)Apryse Software Corp2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K212984, 2019–2026Source: 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), 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 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
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
*K182572InstaRISPACS / InstaZFP / InstaMobi v5.0
Summary page 4
…1 CFR 892.2050) Regulatory Class: II Product Code: LLZ III. PREDICATE DEVICES The predicate device is: InstaRISPACS / InstaZFP / InstaMobi V5.0 (K182572), Class II, regulation number; 892.2050, product code LLZ. IV. DEVICE DESCRIPTION MiPACS HTML5 is a medical soft…
Meddiff Technologies Pvt., Ltd.2019—

Also cleared against K182572: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K260231MiPACS V5 (1.0.0)Apryse Software Corp20260

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?

  • Its one ancestor has no recall.
  • Of its descendants, K260231 (Apryse Software Corp, 2026) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K182572.

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. 2021, this device’s year, is highlighted.

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—

What is it indicated for?

MiPACS HTMLS Web Viewer, is a software device, that enables Users to view and manipulate medical images. Patient images/studies can be accessed by Users locally within the system or across a wide-area network at distributed locations. The MiPACS HTMLS5 Web Viewer requires no installation on the client’s behalf and is compatible with any HTML5-compliant web browser (e.g. Google Chrome, Microsoft Internet Explorer 10, Microsoft Edge, Mozilla Firefox…

Read the full statement (135 words)

MiPACS HTMLS Web Viewer, is a software device, that enables Users to view and manipulate medical images. Patient images/studies can be accessed by Users locally within the system or across a wide-area network at distributed locations. The MiPACS HTMLS5 Web Viewer requires no installation on the client’s behalf and is compatible with any HTML5-compliant web browser (e.g. Google Chrome, Microsoft Internet Explorer 10, Microsoft Edge, Mozilla Firefox, MacOS). Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Mammographic images with lossy, compression and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA.

MiPACS HTMLS5 Web Viewer, is not intended for diagnostic image review on mobile devices.

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 K182572

1 other device cites the same predicate.

  • K211863eVolve PACSEvolve Pacs, Inc. · 2021

Recent decisions in LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • 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/K212984 · printed Nov 6, 2026

Cite this page

510(k) Report. “K212984: MiPACS HTML5 Web Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212984

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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