510(k) · Cleared
ClearedVisaris Avanse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visaris D.O.O. Belgrade · KPR System, X-Ray, Stationary
Cleared on Jun 8, 2015 as substantially equivalent to K091364 (Oehm Und Rehbein GmbH, 2009) after an 80-day review. Its family tree reaches back 7 generations to 1990. 1 later device descends from it.
- Decided
- Jun 8, 2015
- Review
- 80 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K896095 (1990). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 6 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 5 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 4 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 3 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 2 generations backK070618 Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007
- 1 generation backK091364 Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH · 2009
- This deviceK150725 Visaris AvanseVisaris D.O.O. Belgrade · 2015
- Descendant · cites it directly · 0 of its ownK161937 CuattroDRCuattro, LLC · 2016 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K161937CuattroDRCuattro, LLC · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −6 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −5 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −4 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −3 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −2 | K070618 | Dicompacs, Model 5 | Oehm Und Rehbein GmbH | 2007 | — |
| −1 | K091364 | Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4 | Oehm Und Rehbein GmbH | 2009 | — |
| 0 (this device) | K150725 | Visaris Avanse | Visaris D.O.O. Belgrade | 2015 | — |
| +1 | K161937 | CuattroDR | Cuattro, LLC | 2016 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 KPR? 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 KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 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 |
|---|---|---|---|
| * | K091364 | Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Summary page 4…LLZ Regulation Number: 21 CFR 892.2050 Common Product Name: Radiological Image Processing System 510(k) Number: K091364 2. Device description: 21 CFR 807 92 (a) (4) Visaris Avanse® is a digital radiography imaging, control and management so… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161937 | CuattroDR | 2016 | 0 |
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 25 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K161937 (Cuattro, LLC, 2016) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K091364.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
The purpose of Visaris Avanse® is to acquire, store, communicate, display and process medical X-ray images. It offers features (e.g. window leveling, zoom, measurements, annotations etc.) routinely used by medical professionals, such as radiologists and radiographers. Visaris Avanse supports printing to DICOM compatible printers. Within a network environment Visaris Avanse may provide other modalities with a DICOM worklist and a DICOM worklist service.…
Read the full statement (133 words)
The purpose of Visaris Avanse® is to acquire, store, communicate, display and process medical X-ray images. It offers features (e.g. window leveling, zoom, measurements, annotations etc.) routinely used by medical professionals, such as radiologists and radiographers. Visaris Avanse supports printing to DICOM compatible printers. Within a network environment Visaris Avanse may provide other modalities with a DICOM worklist and a DICOM worklist service. Images and worklists can be sent and received using the DICOM protocol. Visaris Avanse has a modular system architecture. It consists of the basic application for image acquisition, processing and viewing as well as a number of other modules for image and worklist management, archiving, search and display. Beside the basic functionality Visaris Avanse also provides a user interface for generator control and image acquisition of medical images DR detectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150725 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150725: Visaris Avanse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150725
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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