510(k) · Cleared
ClearedFulaccess Model 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fulcrum Medical, Inc. · LLZ System, Image Processing, Radiological
Cleared on Oct 29, 2010 as substantially equivalent to K071964 (Mimvista Corp., 2007) and 1 other predicate after a 134-day review. Its family tree reaches back 10 generations to 1996. 3 later devices descend from it.
- Decided
- Oct 29, 2010
- Review
- 134 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K954874 (1996). 57 ancestors in all, the oldest K871859 (1987). 3 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 6 generations between
- 3 generations backK062163 MimviewerMimvista Corp. · 2006
- 2 generations backK070248 VelocityaisVelocity Medical Solutions, LLC · 2007
- 1 generation backK081076 Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC · 2008 · Recalled
- This deviceK101707 Fulaccess Model 1.0Fulcrum Medical, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK182855 ProKnow DSProknow, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK251363 ProKnow DSElekta Solutions AB · 2025
- Descendant · 2 generations on · 0 of its ownK193498 Infinitt RT PACSInfinitt Healthcare Co., Ltd. · 2020
Show all 10 generations
- Root · 10 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 9 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 8 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 7 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 6 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 5 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 4 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 3 generations backK062163 MimviewerMimvista Corp. · 2006
- 2 generations backK070248 VelocityaisVelocity Medical Solutions, LLC · 2007
- 1 generation backK081076 Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC · 2008 · Recalled
- This deviceK101707 Fulaccess Model 1.0Fulcrum Medical, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −9 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −8 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −7 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −6 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −5 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −4 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −3 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −2 | K070248 | Velocityais | Velocity Medical Solutions, LLC | 2007 | — |
| −1 | K081076 | Velocityais, Velocity AI, Velocityvx, Velocityrt, V-Response | Velocity Medical Solutions, LLC | 2008 | 1 |
| 0 (this device) | K101707 | Fulaccess Model 1.0 | Fulcrum Medical, Inc. | 2010 | — |
| +1 | K182855 | ProKnow DS | Proknow, LLC | 2019 | — |
| +2 | K251363 | ProKnow DS | Elekta Solutions AB | 2025 | — |
| +2 | K193498 | Infinitt RT PACS | Infinitt Healthcare Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K071964 | Mim 4.1 (Seastar)Summary page 1…50) Regulatory Class: Class 1I Product Code: LLZ 3. Predicate Device(s): K071964 MIM 4.1 MIlMVista Corporation K081076 Velocity Al. Velocity Medical Solutions, LL… | 2007 |
| * | K081076 | Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseSummary page 1…Product Code: LLZ 3. Predicate Device(s): K071964 MIM 4.1 MIlMVista Corporation K081076 Velocity Al. Velocity Medical Solutions, LLC 4. Description of Device: fulAccess is a s… | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182855 | ProKnow DS | 2019 | 2 |
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 14 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 15 of the 57 ancestors have a recall of any class.
- Of its descendants, K182855 (Proknow, LLC, 2019) has gone furthest, with 2 descendants of its own.
- 9 other devices also cite its predicate K071964.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
fulAccess is a standalone software product that provides basic image processing and communication functionality for use in radiology, oncology, and other clinical specialties. With fulAccess the user can review images from different modalities including CT, MR, and PET, perform basic functions including zoom, pan, measure, sample pixel intensity, and make annotations. Users may also create and save a set of files that include a copy of the data being…
Read the full statement (174 words)
fulAccess is a standalone software product that provides basic image processing and communication functionality for use in radiology, oncology, and other clinical specialties. With fulAccess the user can review images from different modalities including CT, MR, and PET, perform basic functions including zoom, pan, measure, sample pixel intensity, and make annotations. Users may also create and save a set of files that include a copy of the data being viewed, any annotations, and an instance of the viewer executable. These files can be stored locally or on portable media (e.g. CD and DVD).
fulAccess is a Windows application and will be used on recommended hardware that is provided by the company or the end user.
fulAccess is a stand-alone software package that assists users in the display, analysis, comparison and communication of medical imaging data from various sources. It allows the display, analysis, annotation, and communication of medical images. The intended users of fulAccess are trained medical professionals including physicians, nurses, physicists and other medical technologists. fulAccess is not intended for use in mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101707 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101707: Fulaccess Model 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101707
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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