510(k) · Cleared
Recalled · Class II · 2025Ambra PACS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dicom Grid Dba Ambra Health · LLZ System, Image Processing, Radiological
Cleared on Jun 7, 2023 as substantially equivalent to K202335 (Dicom Grid Inc Dba Ambra Health, 2020) after a 28-day review. Its family tree reaches back 9 generations to 1994. It has been recalled once.
- Decided
- Jun 7, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K942120 (1994). 29 ancestors in all, the oldest K913475 (1991). No later device cites it as a predicate yet.
- Root · 9 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 5 generations between
- 3 generations backK063470 Aycan Workstation OsirixAycan Digitalsysteme GmbH · 2007
- 2 generations backK101342 Osirix MDPixmeo Sarl · 2010
- 1 generation backK202335 Ambra ProViewerDicom Grid Inc Dba Ambra Health · 2020 · Recalled
- This deviceK231360 Ambra PACSDicom Grid Dba Ambra Health · 2023
Show all 9 generations
- Root · 9 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 8 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 7 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 6 generations backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- 5 generations backK052358 Etiam Star Pacs ComponentsEtiam, S.A. · 2005
- 4 generations backK062488 IQ-System Pacs SystemImage Information Systems, Ltd. · 2006
- 3 generations backK063470 Aycan Workstation OsirixAycan Digitalsysteme GmbH · 2007
- 2 generations backK101342 Osirix MDPixmeo Sarl · 2010
- 1 generation backK202335 Ambra ProViewerDicom Grid Inc Dba Ambra Health · 2020 · Recalled
- This deviceK231360 Ambra PACSDicom Grid Dba Ambra Health · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −8 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −7 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −6 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| −5 | K052358 | Etiam Star Pacs Components | Etiam, S.A. | 2005 | — |
| −4 | K062488 | IQ-System Pacs System | Image Information Systems, Ltd. | 2006 | — |
| −3 | K063470 | Aycan Workstation Osirix | Aycan Digitalsysteme GmbH | 2007 | — |
| −2 | K101342 | Osirix MD | Pixmeo Sarl | 2010 | — |
| −1 | K202335 | Ambra ProViewer | Dicom Grid Inc Dba Ambra Health | 2020 | 1 |
| 0 (this device) | K231360 | Ambra PACS | Dicom Grid Dba Ambra Health | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K202335 | Ambra ProViewerSummary page 5…er Manufacturer: DICOM GRID Inc., dba Ambra Health Regulation Name: Picture Archive and Communication System Predicate Device Premarket Notification #: K202335 Predicate Device Regulation number: 21 CFR 892.2050 Predicate Classification and Product Code: Class II, LLZ === Pag… | 2020 |
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
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 18, 2025 | Class II | Z-0941-2026 | Software design | Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction applied; Manual… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 9 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 29 ancestors have a recall of any class.
- 1 other device also cites its predicate K202335.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Ambra PACS software is intended for use as a primary diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to Patient image, demographic and report information. Ambra Pro Viewer, a component of Ambra PACS, displays, modifies and manages diagnostic quality DICOM images including 3D visualization and reordering functionality. Lossy compressed…
Read the full statement (102 words)
Ambra PACS software is intended for use as a primary diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to Patient image, demographic and report information.
Ambra Pro Viewer, a component of Ambra PACS, displays, modifies and manages diagnostic quality DICOM images including 3D visualization and reordering functionality.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretations. Mammographic images may only be viewed using cleared monitors intended for mammography Display.
Not intended for diagnostic use on mobile devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231360 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231360: Ambra PACS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231360
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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