510(k) · Cleared
ClearedMedstreaming Medical Office Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medstreaming, LLC · LLZ System, Image Processing, Radiological
Cleared on Nov 6, 2007 after a 15-day review. The FDA summary names its predicate without a number.
- Decided
- Nov 6, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | ProSolv Cardiovascular Viewer, Analyzer and Server Named without a submission number |
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.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The MEDStreaming Medical Office software provides a means of opening and displaying image files. The MEDStreaming Medical Office software provides a means of transferring medical image files using a DICOM network method from the modality acquisition devices to the MEDStreaming Medical Office server. MEDStreaming's Medical Office provides a means for transferring the acquired studies to a DICOM compliant archive device using standard networking methods.…
Read the full statement (280 words)
The MEDStreaming Medical Office software provides a means of opening and displaying image files.
The MEDStreaming Medical Office software provides a means of transferring medical image files using a DICOM network method from the modality acquisition devices to the MEDStreaming Medical Office server.
MEDStreaming's Medical Office provides a means for transferring the acquired studies to a DICOM compliant archive device using standard networking methods.
The MEDStreaming Medical Office software provides a means to retrieve and view image data located on an acquisition or archive device using a standard network connection.
The MEDStreaming Medical Office software provides a means for querying and retrieving patient studies from a networked DICOM server device.
MEDStreaming's Medical Office provides a means to digitize video information from connected imaging modalities using a standard video digitizing engine.
The MEDStreaming Medical Office software provides a means of creating AVI, BMP and JPG graphic files from the image data displayed by the software.
The MEDStreaming Medical Office software provides a means of quantifying the image data using standard measurement tools.
The MEDStreaming Medical Office software provides a means of transferring the DICOM Structured Reporting components provided by a connected acquisition device.
MEDStreaming's Medical Office provides a means of transferring labeled measurements using a serial gateway from modality devices that support a serial data transfer method.
MEDStreaming's Medical Office provides a means of generating an examination report for patient studies reviewed on Medical Office utilizing Microsoft standard text, spreadsheet and database programs.
MEDStreaming's Medical Office provides a means for importing and exporting patient information in HL7 format.
MEDStreaming's Medical Office provides a method for generating utilization reports for data contained within the MEDStreaming patient database using standard Microsoft database tools.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072972 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072972: Medstreaming Medical Office Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072972
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026