510(k) · Cleared
ClearedMerge Universal Viewer (MUV)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merge Healthcare Incorporated · LLZ System, Image Processing, Radiological
Cleared on Apr 14, 2025 as substantially equivalent to K203104 (Merge Healthcare Incorporated, 2021) after a 73-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- Apr 14, 2025
- Review
- 73 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K904519 (1991). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 6 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 5 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 4 generations backK022881 Cedara I-SoftviewCedara Software Corp. · 2002 · Recalled
- 3 generations backK092915 Cedara Webaccess, Model: 2.4Cedara Software Corp. · 2010 · Recalled
- 2 generations backK182290 IBM iConnect AccessMerge Healthcare Incorporated · 2018
- 1 generation backK203104 IBM iConnect AccessMerge Healthcare Incorporated · 2021
- This deviceK250301 Merge Universal Viewer (MUV)Merge Healthcare Incorporated · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −6 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −5 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −4 | K022881 | Cedara I-Softview | Cedara Software Corp. | 2002 | 3 |
| −3 | K092915 | Cedara Webaccess, Model: 2.4 | Cedara Software Corp. | 2010 | 4 |
| −2 | K182290 | IBM iConnect Access | Merge Healthcare Incorporated | 2018 | — |
| −1 | K203104 | IBM iConnect Access | Merge Healthcare Incorporated | 2021 | — |
| 0 (this device) | K250301 | Merge Universal Viewer (MUV) | Merge Healthcare Incorporated | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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.
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 5 companies; a new generation was cleared every 4.2 years on median.
- 6 of the 15 ancestors have a recall of any class.
- 1 other device also cites its predicate K203104.
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?
Merge Universal Viewer (MUV) is intended to provide internet access to multi-modality softcopy medical images, medical data, reports, and other patient-related information to conduct diagnostic review, processing, analyzing, reporting and sharing of DICOM-compliant medical images and relevant digital data. MUV provides functionality that allows for creating and outputting digital files suitable for the fabrication of physical replicas, such as 3D…
Read the full statement (211 words)
Merge Universal Viewer (MUV) is intended to provide internet access to multi-modality softcopy medical images, medical data, reports, and other patient-related information to conduct diagnostic review, processing, analyzing, reporting and sharing of DICOM-compliant medical images and relevant digital data.
MUV provides functionality that allows for creating and outputting digital files suitable for the fabrication of physical replicas, such as 3D printing, using DICOM files as inputs. Physical/3D printed models generated from the digital output files are not for diagnostic use.
MUV is intended to be used by trained healthcare professionals.
MUV can be configured to provide either lossless or lossy compressed images for display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. Use of MUV on mobile devices such as iPhones and iPads is not intended for diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250301: Merge Universal Viewer (MUV).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250301
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