510(k) · Cleared
ClearedBraid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Braid.Health · LLZ System, Image Processing, Radiological
Cleared on Aug 13, 2020 as substantially equivalent to K151957 (Box, Inc., 2015) and 1 other predicate after a 136-day review. Its family tree reaches back 11 generations to 1996. 1 later device descends from it.
- Decided
- Aug 13, 2020
- Review
- 136 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K954874 (1996). 88 ancestors in all, the oldest K842308 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 7 generations between
- 3 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 2 generations backK143397 ICIS ViewAgfa Healthcare N.V. · 2015
- 1 generation backK170434 Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V. · 2017 · Recalled
- This deviceK200822 BraidBraid.Health · 2020
- Descendant · cites it directly · 0 of its ownK231385 Rology Teleradiology Platform (v.1.22.1103)Rology, Inc. · 2023
Show all 11 generations
- Root · 11 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 10 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 9 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 8 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 7 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 6 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 5 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 4 generations backK062163 MimviewerMimvista Corp. · 2006
- 3 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 2 generations backK143397 ICIS ViewAgfa Healthcare N.V. · 2015
- 1 generation backK170434 Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V. · 2017 · Recalled
- This deviceK200822 BraidBraid.Health · 2020
Most influential descendants
Showing 1 of 1 · See all- K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −10 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −9 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −8 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −7 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −6 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −5 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −4 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −3 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −2 | K143397 | ICIS View | Agfa Healthcare N.V. | 2015 | — |
| −1 | K170434 | Enterprise Imaging XERO Viewer 8.1 | Agfa Healthcare N.V. | 2017 | 2 |
| 0 (this device) | K200822 | Braid | Braid.Health | 2020 | — |
| +1 | K231385 | Rology Teleradiology Platform (v.1.22.1103) | Rology, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 6 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 6 | 0 |
| 1997 | 4 | 0 |
| 1998 | 8 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K151957 | BOX DICOM ViewerSummary page 4…Viewer 8.1 Manufacturer: BOX INC. Agfa HealthCare N.V. 510(k) Number: K151957 K170434 510(k) Summary… | 2015 |
| * | K170434 | Enterprise Imaging XERO Viewer 8.1Summary page 4…Viewer 8.1 Manufacturer: BOX INC. Agfa HealthCare N.V. 510(k) Number: K151957 K170434 510(k) Summary Page 2 of 10 Referen… | 2017 |
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 |
|---|---|---|---|
| K231385 | Rology Teleradiology Platform (v.1.22.1103) | 2023 | 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 24 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 14 of the 88 ancestors have a recall of any class.
- Of its descendants, K231385 (Rology, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K151957.
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?
Braid is a software teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web. Braid is used by hospitals, clinics, imaging centers, and radiologist reading practices. Braid can optionally be used for mobile diagnostic use for review and analysis of CR, DX, CT, and MR images and medical reports. Braid mobile…
Read the full statement (174 words)
Braid is a software teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web. Braid is used by hospitals, clinics, imaging centers, and radiologist reading practices.
Braid can optionally be used for mobile diagnostic use for review and analysis of CR, DX, CT, and MR images and medical reports. Braid mobile diagnostic use is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. Braid mobile diagnostic use is not intended for the display of mammography images for diagnosis.
When images are reviewed and use as an element of diagnosis, it is the responsibility of the trained physician to determine if the image quality is suitable for their clinical application.
Contraindications: Braid is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose radiological image data.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200822 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200822: Braid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200822
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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