510(k) · Cleared
ClearedDeepLook PRECISE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deeplook, Inc. · LLZ System, Image Processing, Radiological
Cleared on Apr 9, 2021 as substantially equivalent to K191530 (Imaging Biometrics, LLC, 2019) after a 256-day review. Its family tree reaches back 13 generations to 1991.
- Decided
- Apr 9, 2021
- Review
- 256 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K913770 (1991). 64 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 13 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations between
- 3 generations backK120484 Visia OncologyMeVis Medical Solutions AG · 2012
- 2 generations backK141745 Iqqa-Bodyimaging SoftwareEdda Technology · 2014
- 1 generation backK191530 StoneCheckerImaging Biometrics, LLC · 2019
- This deviceK202084 DeepLook PRECISEDeeplook, Inc. · 2021
Show all 13 generations
- Root · 13 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 12 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 11 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 10 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 9 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 8 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 7 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 6 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 5 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 4 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 3 generations backK120484 Visia OncologyMeVis Medical Solutions AG · 2012
- 2 generations backK141745 Iqqa-Bodyimaging SoftwareEdda Technology · 2014
- 1 generation backK191530 StoneCheckerImaging Biometrics, LLC · 2019
- This deviceK202084 DeepLook PRECISEDeeplook, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −12 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −11 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −10 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −9 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −8 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −7 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −6 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −5 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −4 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| −3 | K120484 | Visia Oncology | MeVis Medical Solutions AG | 2012 | — |
| −2 | K141745 | Iqqa-Bodyimaging Software | Edda Technology | 2014 | — |
| −1 | K191530 | StoneChecker | Imaging Biometrics, LLC | 2019 | — |
| 0 (this device) | K202084 | DeepLook PRECISE | Deeplook, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K191530 | StoneCheckerSummary page 4…ass: 11 III. PREDICATE DEVICE [Device Classification Name System, Image Processing, Radiological] 1510(K) Number K191530 [Device Name StoneChecker Applicant Imaging Biometrics, LLC… | 2019 |
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 30 years and passes through 8 companies; a new generation was cleared every 12 months on median.
- 15 of the 64 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. 2021, 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?
DeepLook PRECISE is a software device that is integrated into medical Image Viewers and PACS workstations to assist trained professionals in measuring dimensions of objects within a region of interest (ROI) that is identified by the user in DICOM images. The generated information consists of an estimated greatest long-axis and greatest short-axis dimensions, area, volume, and margin of the objects. For illustration purposes, DeepLook PRECISE can…
Read the full statement (177 words)
DeepLook PRECISE is a software device that is integrated into medical Image Viewers and PACS workstations to assist trained professionals in measuring dimensions of objects within a region of interest (ROI) that is identified by the user in DICOM images. The generated information consists of an estimated greatest long-axis and greatest short-axis dimensions, area, volume, and margin of the objects. For illustration purposes, DeepLook PRECISE can optionally provide a colorization of the interior area defined by a margin. DeepLook PRECISE does not make clinical decisions nor is a decision-support tool. The information provided by the software is an initial estimate and must not be used in isolation when making patient management decisions.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using and FDA cleared monitor that offers at least 5 Mega-pixel resolutions and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained physicians and radiologists.
DeepLook PRECISE, is not intended for use on mobile devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202084 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202084: DeepLook PRECISE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202084
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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