510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Novapacs

K063153510(k) TraditionalCleared Dec 7, 200652-day reviewClass II21 CFR 892.2050Recalls 1

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

Novarad Corp. · LLZ System, Image Processing, Radiological

Cleared on Dec 7, 2006 after a 52-day review. The FDA summary names its predicate without a number. 7 later devices descend from it. It has been recalled once.

Decided
Dec 7, 2006
Review
52 days
Class
Class II
Product code
LLZ
Recalls
1
Predicates
0

7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant cleared2024: 1 descendant cleared2022: 1 descendant cleared2025: 2 descendants cleared20052010201520202025
  1. This deviceK063153 NovapacsNovarad Corp. · 2006
  2. Descendant · cites it directly · 6 of its ownK132853 NovapacsNovarad Corp. · 2014 · Recalled
  3. Descendant · 2 generations on · 5 of its ownK160371 NovaPACSNovarad Corporation · 2016
  4. Descendant · 3 generations on · 4 of its ownK171754 NovaPACSNovarad Corporation · 2017 · Recalled
  5. Descendant · 4 generations on · 1 of its ownK231662 Aid-UIaid · 2024
  6. Descendant · 4 generations on · 1 of its ownK221796 Cyware 4H and Cysart 4HAbys Medical · 2022

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2014: 12016: 12017: 12022: 12024: 12025: 2
2014high 2 (2025) · low 0 (2015)2026

Most influential descendants

Showing 5 of 7 · See all
  • K132853NovapacsNovarad Corp. · 2014 · cites it directly6descendants
  • K160371NovaPACSNovarad Corporation · 2016 · 2 generations on5descendants
  • K171754NovaPACSNovarad Corporation · 2017 · 3 generations on4descendants
  • K231662Aid-UIaid · 2024 · 4 generations on1descendant
  • K221796Cyware 4H and Cysart 4HAbys Medical · 2022 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K063153NovapacsNovarad Corp.2006—
+1K132853NovapacsNovarad Corp.20142
+2K160371NovaPACSNovarad Corporation2016—
+3K171754NovaPACSNovarad Corporation20171
+4K231662Aid-UIaid2024—
+4K221796Cyware 4H and Cysart 4HAbys Medical2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201610
201710
202210
202410
202520
FIG. 1 — Lineage of K063153, 2006–2025Source: 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
*—Kodak DirectView (Carestream) PACS product
Named without a submission number
—

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K132853NovapacsNovarad Corp.20146

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 9, 2013Class IIZ-2151-2016Software designPotential for images to be flipped while streaming, which could incorrectly display image orientation markers.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K132853 (Novarad Corp., 2014) has gone furthest, with 6 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—

What is it indicated for?

The product being submitted is going to be used as a PACS system and provide viewing tools for radiologists, technologists, other physicians, cardiologists, and patients. It will also provide archiving of images and data. The product will be sold to hospitals, imaging centers, and clinics. It is a software product sold with accompanying off-the-shelf hardware. It is substantially equivalent to other products now being sold as PACS. Further it is for…

Read the full statement (138 words)

The product being submitted is going to be used as a PACS system and provide viewing tools for radiologists, technologists, other physicians, cardiologists, and patients. It will also provide archiving of images and data. The product will be sold to hospitals, imaging centers, and clinics. It is a software product sold with accompanying off-the-shelf hardware. It is substantially equivalent to other products now being sold as PACS. Further it is for using DICOM for presentation of Mammography studies, not for image processing. Will include the standard features for Mammo of window/level/zoom, as well as volumetric measurements and other Mammo tools. Mammo will only be interpreted on 51 OK approved 5 Mp LCD monitors. The Mammo images will be stored lossless (non-lossy compressed). Digitized conventional screen film mammograms will not be used in soft copy format for primary diagnosis.

Indications for use as stated in the FDA summary.

More from Novarad Corp.

3 FDA decisions under this applicant name. See the company

  • K132853NovapacsNovarad Corp. · 20142 recalls
  • K061920Novapacs, Novaview, Novacardio, Novaqc and NovaerNovarad Corp. · 2006

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/K063153 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063153: Novapacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063153

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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