510(k) · Cleared
ClearedASTRA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Candelis, Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 15, 2011 as substantially equivalent to K092949 (Candelis, Inc., 2009) and 1 other predicate after a 91-day review. Its family tree reaches back 9 generations to 1996. 5 later devices descend from it.
- Decided
- Sep 15, 2011
- Review
- 91 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K954874 (1996). 35 ancestors in all, the oldest K885054 (1989). 5 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 5 generations between
- 3 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 2 generations backK062163 MimviewerMimvista Corp. · 2006
- 1 generation backK103785 Mobile MimMim Software, Inc. · 2011
- This deviceK111694 ASTRACandelis, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK140960 Picture Archiving and Communications SystemHologic, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK190694 Unifi Workspace v1.0.0Hologic, Inc. · 2019
- Descendant · 3 generations on · 1 of its ownK220767 TeleScanBb Imaging · 2022
- Descendant · 4 generations on · 0 of its ownK233634 TeleScanBb Imaging · 2023
- Descendant · cites it directly · 0 of its ownK143176 UltraLinqUltralinq Healthcare Solutions, Inc. · 2015
Show all 9 generations
- Root · 9 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 8 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 7 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 6 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 5 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 4 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 3 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 2 generations backK062163 MimviewerMimvista Corp. · 2006
- 1 generation backK103785 Mobile MimMim Software, Inc. · 2011
- This deviceK111694 ASTRACandelis, Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K140960Picture Archiving and Communications SystemHologic, Inc. · 2014 · cites it directly3descendants
- K190694Unifi Workspace v1.0.0Hologic, Inc. · 2019 · 2 generations on2descendants
- K220767TeleScanBb Imaging · 2022 · 3 generations on1descendant
- K233634TeleScanBb Imaging · 2023 · 4 generations on0descendants
- K143176UltraLinqUltralinq Healthcare Solutions, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −8 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −7 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −6 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −5 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −4 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −3 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −2 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −1 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| 0 (this device) | K111694 | ASTRA | Candelis, Inc. | 2011 | — |
| +1 | K140960 | Picture Archiving and Communications System | Hologic, Inc. | 2014 | — |
| +2 | K190694 | Unifi Workspace v1.0.0 | Hologic, Inc. | 2019 | — |
| +3 | K220767 | TeleScan | Bb Imaging | 2022 | — |
| +4 | K233634 | TeleScan | Bb Imaging | 2023 | — |
| +1 | K143176 | UltraLinq | Ultralinq Healthcare Solutions, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K092949 | Imagegrid Radiology Viewer SystemSummary page 1…lassification Name: 892.2050 Image Processing System Product Code: LLZ Predicate Device(s): 21 CFR 807.92(a)(3) 510(k) Number K092949 K103785 Manufacturer: Candelis, Inc. MIM Software, Inc Device Name:… | 2009 |
| * | K103785 | Mobile MimSummary page 1…age Processing System Product Code: LLZ Predicate Device(s): 21 CFR 807.92(a)(3) 510(k) Number K092949 K103785 Manufacturer: Candelis, Inc. MIM Software, Inc Device Name: ImageGrid R… | 2011 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 35 ancestors have a recall of any class.
- Of its descendants, K140960 (Hologic, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K092949.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
ASTRA is software image management intended to receive, process, review, display, print and archive medical images and data from imaging modalities (e.g., CR and DR). Images and data can be stored, communicated, and displayed within the system or across computer systems. ASTRA is comprised with three configurations depending upon the requirements of the user and desired options: ASTRA Plus, ASTRA Lite, and ASTRA Mobile. ASTRA runs on a PC workstation…
Read the full statement (287 words)
ASTRA is software image management intended to receive, process, review, display, print and archive medical images and data from imaging modalities (e.g., CR and DR). Images and data can be stored, communicated, and displayed within the system or across computer systems. ASTRA is comprised with three configurations depending upon the requirements of the user and desired options: ASTRA Plus, ASTRA Lite, and ASTRA Mobile. ASTRA runs on a PC workstation, iPad, or Phone and may be interfaced with verified and validated image acquisition devices from Candelis or other PACS systems. Diagnosis is not performed by the software but by Radiologists, Clinicians or referring Physicians. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
ASTRA Plus is used to:
share reports and studies with other ASTRA peers
review reports and studies
download and save reports
send reports to local EMR, EHR, RIS, HIS or PACS systems (HL7 send)
route studies to PACS, Workstations, or other ASTRA peers
ASTRA Lite is used to:
share reports and studies with other ASTRA peers
review reports and studies
download and save reports
send reports to local EMR, EHR, RIS, HIS or PACS systems (HL7 send)
ASTRA Mobile is used to:
share reports with other ASTRA peers
review reports
download and save reports
send reports to local EMR, EHR, RIS, HIS or PACS systems (HL7 send)
Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA.
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/K111694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111694: ASTRA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111694
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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