510(k) · Cleared
ClearedTeleScan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bb Imaging · LLZ System, Image Processing, Radiological
Cleared on Dec 12, 2023 as substantially equivalent to K220767 (Bb Imaging, 2022) after a 29-day review. Its family tree reaches back 13 generations to 1996.
- Decided
- Dec 12, 2023
- Review
- 29 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K954874 (1996). 47 ancestors in all, the oldest K885054 (1989). No later device cites it as a predicate yet.
- Root · 13 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 9 generations between
- 3 generations backK140960 Picture Archiving and Communications SystemHologic, Inc. · 2014
- 2 generations backK190694 Unifi Workspace v1.0.0Hologic, Inc. · 2019
- 1 generation backK220767 TeleScanBb Imaging · 2022
- This deviceK233634 TeleScanBb Imaging · 2023
Show all 13 generations
- Root · 13 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 12 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 11 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 10 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 9 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 8 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 7 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 6 generations backK062163 MimviewerMimvista Corp. · 2006
- 5 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 4 generations backK111694 ASTRACandelis, Inc. · 2011
- 3 generations backK140960 Picture Archiving and Communications SystemHologic, Inc. · 2014
- 2 generations backK190694 Unifi Workspace v1.0.0Hologic, Inc. · 2019
- 1 generation backK220767 TeleScanBb Imaging · 2022
- This deviceK233634 TeleScanBb Imaging · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −12 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −11 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −10 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −9 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −8 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −7 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −6 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −5 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −4 | K111694 | ASTRA | Candelis, Inc. | 2011 | — |
| −3 | K140960 | Picture Archiving and Communications System | Hologic, Inc. | 2014 | — |
| −2 | K190694 | Unifi Workspace v1.0.0 | Hologic, Inc. | 2019 | — |
| −1 | K220767 | TeleScan | Bb Imaging | 2022 | — |
| 0 (this device) | K233634 | TeleScan | Bb Imaging | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K220767 | TeleScanSummary page 4…Radiology Type of 510(k) Submission: Special Reason for Submission: Design Update 3 Predicate Information Predicate: TeleScan® Predicate 510(k): K220767 4 Device Description TeleScan® is used by trained medical professionals, including radiologists, sonographers, technologists,… | 2022 |
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 27 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 8 of the 47 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
TeleScan® is a software application that is intended for use in receiving, processing, manipulating, displaying, printing, and archiving ultrasound medical images and data. Images and data can be stored, communicated, and displayed within the system or across computer systems. TeleScan® provides various image processing and measurement tools to facilitate the interpretation of ultrasound DICOM medical images and enable diagnosis. TeleScan® is used by…
Read the full statement (99 words)
TeleScan® is a software application that is intended for use in receiving, processing, manipulating, displaying, printing, and archiving ultrasound medical images and data. Images and data can be stored, communicated, and displayed within the system or across computer systems. TeleScan® provides various image processing and measurement tools to facilitate the interpretation of ultrasound DICOM medical images and enable diagnosis.
TeleScan® is used by appropriately trained healthcare professionals, including radiologists, sonographers, technologists, and clinicians, in a medical facility. TeleScan® may provide information to be used for diagnostic procedures. TeleScan® allows remote qualified radiologists and clinicians to provide a diagnosis remotely.
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/K233634 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233634: TeleScan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233634
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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