510(k) · Cleared
ClearedHPACS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthhub · LLZ System, Image Processing, Radiological
Cleared on Oct 3, 2025 as substantially equivalent to K231662 (Iaid, 2024) after a 268-day review. Its family tree reaches back 15 generations to 1991.
- Decided
- Oct 3, 2025
- Review
- 268 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K913770 (1991). 109 ancestors in all, the oldest K885054 (1989). No later device cites it as a predicate yet.
- Root · 15 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 11 generations between
- 3 generations backK160371 NovaPACSNovarad Corporation · 2016
- 2 generations backK171754 NovaPACSNovarad Corporation · 2017 · Recalled
- 1 generation backK231662 Aid-UIaid · 2024
- This deviceK250039 HPACSHealthhub · 2025
Show all 15 generations
- Root · 15 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 14 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 13 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 12 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 11 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 10 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 9 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 8 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 7 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 6 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 5 generations backK072821 Vitrea 4DCTVital Images, Inc. · 2008 · Recalled
- 4 generations backK132853 NovapacsNovarad Corp. · 2014 · Recalled
- 3 generations backK160371 NovaPACSNovarad Corporation · 2016
- 2 generations backK171754 NovaPACSNovarad Corporation · 2017 · Recalled
- 1 generation backK231662 Aid-UIaid · 2024
- This deviceK250039 HPACSHealthhub · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −14 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −13 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −12 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −11 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −10 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −9 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −8 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −7 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −6 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| −5 | K072821 | Vitrea 4DCT | Vital Images, Inc. | 2008 | 1 |
| −4 | K132853 | Novapacs | Novarad Corp. | 2014 | 2 |
| −3 | K160371 | NovaPACS | Novarad Corporation | 2016 | — |
| −2 | K171754 | NovaPACS | Novarad Corporation | 2017 | 1 |
| −1 | K231662 | Aid-U | Iaid | 2024 | — |
| 0 (this device) | K250039 | HPACS | Healthhub | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 8 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 13 | 0 |
| 2002 | 8 | 0 |
| 2003 | 6 | 0 |
| 2004 | 8 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K231662 | Aid-USummary page 5…supported on any OS that is no longer officially supported by its manufacturer (e.g., Windows 7). 05. Predicate Device Identification - Predicate device 510(k) Number: K231662 Device Name: Aid-U Manufacturer: iAID… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 34 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 25 of the 109 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
HPACS is a web-based software solution intended for storing, retrieving, transmitting, viewing, and processing medical images for non-diagnostic purposes. It operates in conjunction with a PACS server to enable access to imaging data. HPACS supports the display and comparison of images from CR, CT, DX, MR, US, XA, and SC modalities that are compliant with the DICOM standard. The system is designed for use by radiologists, technologists, and clinicians…
Read the full statement (169 words)
HPACS is a web-based software solution intended for storing, retrieving, transmitting, viewing, and processing medical images for non-diagnostic purposes. It operates in conjunction with a PACS server to enable access to imaging data.
HPACS supports the display and comparison of images from CR, CT, DX, MR, US, XA, and SC modalities that are compliant with the DICOM standard.
The system is designed for use by radiologists, technologists, and clinicians for reference and review purposes only. It is not intended for primary diagnostic interpretation.
HPACS supports operation on Windows 10 or higher and macOS 12 or higher platforms, exclusively via Google Chrome browser. Compatibility with other browsers or operating systems is not claimed.
HPACS is not intended for diagnostic image reading and should be used under standard indoor lighting conditions for optimal viewing; use in direct sunlight or high-glare environments is not recommended, and mobile or tablet devices are not supported. HPACS is not supported on any OS that is no longer officially supported by its manufacturer (e.g., Windows 7).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250039: HPACS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250039
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