510(k) · Cleared
Recalled · Class II · 2022Ambra ProViewer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dicom Grid Inc Dba Ambra Health · LLZ System, Image Processing, Radiological
Cleared on Sep 4, 2020 as substantially equivalent to K152977 (Dicom Grid, Inc., 2016) and 1 other predicate after an 18-day review. Its family tree reaches back 8 generations to 1994. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 4, 2020
- Review
- 18 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K942120 (1994). 28 ancestors in all, the oldest K913475 (1991). 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 7 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 6 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 5 generations backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- 4 generations backK052358 Etiam Star Pacs ComponentsEtiam, S.A. · 2005
- 3 generations backK062488 IQ-System Pacs SystemImage Information Systems, Ltd. · 2006
- 2 generations backK063470 Aycan Workstation OsirixAycan Digitalsysteme GmbH · 2007
- 1 generation backK101342 Osirix MDPixmeo Sarl · 2010
- This deviceK202335 Ambra ProViewerDicom Grid Inc Dba Ambra Health · 2020
- Descendant · cites it directly · 0 of its ownK240839 OpenRad CloudOpenrad Services Uk, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK231360 Ambra PACSDicom Grid Dba Ambra Health · 2023 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −7 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −6 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −5 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| −4 | K052358 | Etiam Star Pacs Components | Etiam, S.A. | 2005 | — |
| −3 | K062488 | IQ-System Pacs System | Image Information Systems, Ltd. | 2006 | — |
| −2 | K063470 | Aycan Workstation Osirix | Aycan Digitalsysteme GmbH | 2007 | — |
| −1 | K101342 | Osirix MD | Pixmeo Sarl | 2010 | — |
| 0 (this device) | K202335 | Ambra ProViewer | Dicom Grid Inc Dba Ambra Health | 2020 | — |
| +1 | K240839 | OpenRad Cloud | Openrad Services Uk, Ltd. | 2024 | — |
| +1 | K231360 | Ambra PACS | Dicom Grid Dba Ambra Health | 2023 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K152977 | DG PacsSummary page 4…a PACS Manufacturer: DICOM GRID Inc., dba Ambra Health Common Name: Picture Archive and Communication System Predicate Device Premarket Notification #: K152977 Predicate Device Regulation number: 21 CFR 892.2050 Predicate Classification and Product Code: Class II, LLZ Referen… | 2016 |
| * | K101342 | Osirix MDSummary page 4…Trade Name: Osirix MD Manufacturer: PIXMEO SARL Common Name: Picture Archive and Communication System Predicate Device Premarket Notification #: K101342 Predicate Device Regulation number: 21 CFR 892.2050 510(k) Page Number: 017 === P… | 2010 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 23, 2022 | Class II | Z-1818-2022 | Software design | A race condition between the storage system and services database has the potential to revert edits made to patient information upon first ingestion of a study. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 8 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 28 ancestors have a recall of any class.
- Of its descendants, K240839 (Openrad Services Uk, Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K152977.
How does its category compare?
All LLZ devicesLLZ 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
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 ProViewer, 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 (101 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 ProViewer, 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/K202335 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202335: Ambra ProViewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202335
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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