510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

IntelePACS

K192176510(k) TraditionalCleared Apr 2, 2020234-day reviewClass II21 CFR 892.2050Recalls 3

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

Intelerad Medical Systems Incorporated · LLZ System, Image Processing, Radiological

Cleared on Apr 2, 2020 as substantially equivalent to K150707 (Intelerad Medical Systems Incorporated, 2015) after a 234-day review. Its family tree reaches back 2 generations to 2009. It has been recalled 3 times.

Decided
Apr 2, 2020
Review
234 days
Class
Class II
Product code
LLZ
Recalls
3
Predicates
1

Its longest line of descent runs back 2 generations to K083520 (2009). No later device cites it as a predicate yet.

Reference device: K172490 · eUnity · Client Outlook, Inc. · 2018K083520 · Intelepacs, Model Version 3.X.X · Intelerad Medical Systems Incorporated · 2009 · recalledK150707 · IntelePACS · Intelerad Medical Systems Incorporated · 20152005201020152020
K150707 · IntelePACS · Intelerad Medical Systems Incorporated · 2015K083520 · Intelepacs, Model Version 3.X.X · Intelerad Medical Systems Incorporated · 2009 · recalled0
  1. Root · 2 generations backK083520 Intelepacs, Model Version 3.X.XIntelerad Medical Systems Incorporated · 2009 · Recalled
  2. 1 generation backK150707 IntelePACSIntelerad Medical Systems Incorporated · 2015
  3. This deviceK192176 IntelePACSIntelerad Medical Systems Incorporated · 2020
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K083520Intelepacs, Model Version 3.X.XIntelerad Medical Systems Incorporated20091
−1K150707IntelePACSIntelerad Medical Systems Incorporated2015—
0 (this device)K192176IntelePACSIntelerad Medical Systems Incorporated2020—
FIG. 1 — Lineage of K192176, 2009–2020Source: 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
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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
*K150707IntelePACS
Summary page 4
…g, radiological (21 CFR 892.2050) Regulatory Class: II Product Code: LLZ III. PREDICATE DEVICES Primary Predicate Device IntelePACS, (K150707) v4.9.1 by Intelerad Medical Systems, Inc. CFR 892.2050, Product Code LLZ. Reference Predicate Device…
Intelerad Medical Systems Incorporated2015—
†K172490eUnityClient Outlook, Inc.2018—

Also cleared against K150707: 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)

Recalls of this device

DateClassRecallRoot causeReason
Sep 5, 2026Class IIZ-0186-2027Software designFollowing a Chromium-based web-browser, report and displayed images may not match.
Oct 17, 2025Class IIZ-0723-2026Software Design ChangeSoftware application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case…
Feb 5, 2025Class IIZ-1208-2025Software designA software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptake Value (SUV) incorrectly for PET/CT studies acquired on the days of Daylight…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 5.9 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • 1 other device also cites its predicate K150707.

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. 2020, 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?

IntelePACS is a software application that receives digital images and data from various sources (such as, CT scanners, MR scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and/or across computer networks at distributed locations.…

Read the full statement (171 words)

IntelePACS is a software application that receives digital images and data from various sources (such as, CT scanners, MR scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and/or across computer networks at distributed locations. Post-processing of the images can be performed using Multi Planar Reconstruction (MPR). 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.

When used with a mobile device, IntelePACS is suitable for diagnostic image review only on tested devices as specified in Intelerad product documentation. IntelePACS is not intended for primary diagnostic image review on mobile devices. Mobile usage for Mammography is for reference and referral only.

Indications for use as stated in the FDA summary.

Also cleared against K150707

1 other device cites the same predicate.

  • K162141Restore PACSXian Wingspan Electronic Technology Co., Ltd. · 2016

More from Intelerad Medical Systems Incorporated

3 FDA decisions under this applicant name. See the company

  • K150707IntelePACSIntelerad Medical Systems Incorporated · 2015
  • K083520Intelepacs, Model Version 3.X.XIntelerad Medical Systems Incorporated · 20091 recall

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/K192176 · printed Nov 6, 2026

Cite this page

510(k) Report. “K192176: IntelePACS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192176

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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