510(k) · Cleared
Recalled · Class II · 2016Novapacs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novarad Corp. · LLZ System, Image Processing, Radiological
Cleared on Oct 30, 2014 as substantially equivalent to K063153 (Novarad Corp., 2006) and 4 other predicates after a 413-day review. Its family tree reaches back 11 generations to 1991. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 30, 2014
- Review
- 413 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 11 generations to K913770 (1991). 90 ancestors in all, the oldest K885054 (1989). 6 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations between
- 3 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 2 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 1 generation backK072821 Vitrea 4DCTVital Images, Inc. · 2008 · Recalled
- This deviceK132853 NovapacsNovarad Corp. · 2014
- Descendant · cites it directly · 5 of its ownK160371 NovaPACSNovarad Corporation · 2016
- Descendant · 2 generations on · 4 of its ownK171754 NovaPACSNovarad Corporation · 2017 · Recalled
- Descendant · 3 generations on · 1 of its ownK231662 Aid-UIaid · 2024
- Descendant · 3 generations on · 1 of its ownK221796 Cyware 4H and Cysart 4HAbys Medical · 2022
- Descendant · 4 generations on · 0 of its ownK250039 HPACSHealthhub · 2025
Show all 11 generations
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 9 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 8 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 7 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 6 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 5 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 4 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 3 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 2 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 1 generation backK072821 Vitrea 4DCTVital Images, Inc. · 2008 · Recalled
- This deviceK132853 NovapacsNovarad Corp. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K160371NovaPACSNovarad Corporation · 2016 · cites it directly5descendants
- K171754NovaPACSNovarad Corporation · 2017 · 2 generations on4descendants
- K231662Aid-UIaid · 2024 · 3 generations on1descendant
- K221796Cyware 4H and Cysart 4HAbys Medical · 2022 · 3 generations on1descendant
- K250039HPACSHealthhub · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −10 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −9 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −8 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −7 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −6 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −5 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −4 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −3 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −2 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| −1 | K072821 | Vitrea 4DCT | Vital Images, Inc. | 2008 | 1 |
| 0 (this device) | K132853 | Novapacs | Novarad Corp. | 2014 | — |
| +1 | K160371 | NovaPACS | Novarad Corporation | 2016 | — |
| +2 | K171754 | NovaPACS | Novarad Corporation | 2017 | 1 |
| +3 | K231662 | Aid-U | Iaid | 2024 | — |
| +3 | K221796 | Cyware 4H and Cysart 4H | Abys Medical | 2022 | — |
| +4 | K250039 | HPACS | Healthhub | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 7 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 12 | 0 |
| 2002 | 6 | 0 |
| 2003 | 6 | 0 |
| 2004 | 8 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
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 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K063153 | NovapacsSummary page 4…Prepared: 6 September 2013 Device Name Trade Name: NovaPACS Common Name: PACS Classification Name: System, Imaging Processing, Radiological Predicate Devices K063153 NovaPACS Novarad Corporation K043194… | 2006 |
| * | K043194 | Voxar 3D Product FamilySummary page 4…Name: System, Imaging Processing, Radiological Predicate Devices K063153 NovaPACS Novarad Corporation K043194 Voxar 3D Voxar Enterprise K061214 Ter… | 2005 |
| * | K061214 | Aquariusaps ServerSummary page 4…NovaPACS Novarad Corporation K043194 Voxar 3D Voxar Enterprise K061214 TeraRecon Aquarius APS TeraRecon K072821 Vitrea 4DC… | 2006 |
| * | K072821 | Vitrea 4DCTSummary page 4…Voxar 3D Voxar Enterprise K061214 TeraRecon Aquarius APS TeraRecon K072821 Vitrea 4DCT Vital Images K103785 Mobile… | 2008 |
| * | K103785 | Mobile MimSummary page 4…TeraRecon Aquarius APS TeraRecon K072821 Vitrea 4DCT Vital Images K103785 Mobile MIM MIM Software Inc. (formerly… | 2011 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160371 | NovaPACS | 2016 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 12, 2016 | Class II | Z-2659-2016 | Software design | Novarad Corporation announces a voluntary field action for the NovaPACS versions 8.4.7, 8.5.3, and 8.5.6 due to a "pop-up screen" that was prematurely released. |
| Nov 16, 2015 | Class II | Z-1613-2016 | Software design | The SUV values that are being calculated in the PET/CT fusion tool are incorrect. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 17 of the 90 ancestors have a recall of any class.
- Of its descendants, K160371 (Novarad Corporation, 2016) has gone furthest, with 5 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
NovaPACS is intended for the viewing, archiving, analysis, annotation, registration, distribution, editing, fusion, and processing of digital medical images and data acquired from diagnostic imaging devices and all DICOM devices, etc. NovaPACS is intended for use by trained healthcare professionals, including radiologists, physicians, technologists, clinicians, and nurses. NovaPACS allows the end user to display, manipulate, archive, and evaluate images.…
Read the full statement (113 words)
NovaPACS is intended for the viewing, archiving, analysis, annotation, registration, distribution, editing, fusion, and processing of digital medical images and data acquired from diagnostic imaging devices and all DICOM devices, etc.
NovaPACS is intended for use by trained healthcare professionals, including radiologists, physicians, technologists, clinicians, and nurses. NovaPACS allows the end user to display, manipulate, archive, and evaluate images.
NovaPACS is not intended for diagnostic image review on a mobile platform.
While NovaPACS provides tools to assist the healthcare professional determine diagnostic viability, it is the user's responsibility to ensure quality, display contrast, ambient light conditions, and to confirm image compression ratios are consistent with the generally accepted standards of the clinical application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132853 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132853: Novapacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132853
Report an extraction error
Are you the manufacturer?
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