510(k) · Cleared
ClearedAccessnet, Accessmed, Accessrad, Medview
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aspyra, Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 18, 2010 as substantially equivalent to K973805 (Storcomm, Inc., 1998) and 5 other predicates after a 288-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Mar 18, 2010
- Review
- 288 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K942120 (1994). 27 ancestors in all, the oldest K803130 (1981). No later device cites it as a predicate yet.
- Root · 5 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 4 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 3 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 2 generations backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- 1 generation backK082318 Centricity Pacs IWGe Healthcare Dynamic Imaging Solutions · 2008 · Recalled
- This deviceK091631 Accessnet, Accessmed, Accessrad, MedviewAspyra, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −4 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −3 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −2 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| −1 | K082318 | Centricity Pacs IW | Ge Healthcare Dynamic Imaging Solutions | 2008 | 7 |
| 0 (this device) | K091631 | Accessnet, Accessmed, Accessrad, Medview | Aspyra, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 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? (6)
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 |
|---|---|---|---|
| * | K973805 | Imageaccess SystemSummary page 2…The As~yra PACS is substantially equivalent in operating principle, technology, overall design, function, and intended use to ImageACCESS PACS as described in K973805. Im- age stitching is substantially equivalent in operating principle, technology, overall design, function, and inte… | 1998 |
| * | K003438 | Smart RadSummary page 2…ibed in K973805. Im- age stitching is substantially equivalent in operating principle, technology, overall design, function, and intended use to CMT SmartRAD[K003438]and Fuji Flashllp [K013218] [K041990], and Mammography functionality is substantially equivalent in operating princip… | 2001 |
| * | K013218 | Fuji Speed Suite, Fuji Speed Sute Phase IISummary page 2…age stitching is substantially equivalent in operating principle, technology, overall design, function, and intended use to CMT SmartRAD[K003438]and Fuji Flashllp [K013218] [K041990], and Mammography functionality is substantially equivalent in operating principle, technology, overall des… | 2001 |
| * | K041990 | Fuji Medical CR Console, Model Flash IipSummary page 2…substantially equivalent in operating principle, technology, overall design, function, and intended use to CMT SmartRAD[K003438]and Fuji Flashllp [K013218] [K041990], and Mammography functionality is substantially equivalent in operating principle, technology, overall design, function, a… | 2004 |
| * | K051553 | Fuji Synapse Workstation SoftwareSummary page 2…and Mammography functionality is substantially equivalent in operating principle, technology, overall design, function, and intended use to the Fuji Synapse [K051553] and GE Centricity [K082318]. AD2… | 2005 |
| * | K082318 | Centricity Pacs IWSummary page 2…y is substantially equivalent in operating principle, technology, overall design, function, and intended use to the Fuji Synapse [K051553] and GE Centricity [K082318]. AD2- 107 4 r~DE… | 2008 |
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 16 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 10 of the 27 ancestors have a recall of any class.
- 1 other device also cites its predicate K973805.
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?
The Aspyra AccessNET PACS is a software device designed to operate on specified off-the-shelf hardware and virtual environments. The device is intended to receive digital images and data from various sources including CT scanners, MR scanners, Nuclear Medicine (NM), PET, ultrasound systems, Computed & Direct radiographic devices (CR, DR), secondary capture devices, scanners, imaging gateways, etc. as well as other DICOM compliant modalities. Images and…
Read the full statement (216 words)
The Aspyra AccessNET PACS is a software device designed to operate on specified off-the-shelf hardware and virtual environments. The device is intended to receive digital images and data from various sources including CT scanners, MR scanners, Nuclear Medicine (NM), PET, ultrasound systems, Computed & Direct radiographic devices (CR, DR), secondary capture devices, scanners, imaging gateways, etc. as well as other DICOM compliant modalities. Images and data can be captured, stored, communicated, processed, printed, and displayed within the system and or across computer networks at distributed locations.
Display and processing functions while viewing images include, but are not limited to, adjustment of window and level, rotatidn, zoom, measurement of anatomical structures, image stitching, image stacking, filtration of color images (e.g. removal of red channel), annotation and measurement of regions of interest, inversion, rotation, flips, Multi-Planar Reformation (MPR), and Maximum intensity projection (MIP). In addition, users can dictate, edit, sign, and print reports.
The Aspyra. AccessNET PACS is indicated for the primary review of "For Presentation" DICOM mamnmographic images. Lossy compressed mammographic images and digitized film screen images must not be used for primary image interpretations. Mammographic images for primary image interpretations may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091631 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091631: Accessnet, Accessmed, Accessrad, Medview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091631
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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