510(k) · Cleared
ClearedCardionow Cardiology Wide Area Archive and Retrieval System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardionow, Inc. · LLZ System, Image Processing, Radiological
Cleared on May 10, 2002 as substantially equivalent to K973131 (Siemens Medical Solutions USA, Inc., 1997) after an 88-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- May 10, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K924178 (1993). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK924178 Medvision (TM) Imaging SoftwareEvergreen Technologies, Inc. · 1993
- 2 generations backK970064 Amicas Web/Intranet Image ServerAutocyt Group, Inc. · 1997
- 1 generation backK973131 Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway)Siemens Medical Solutions USA, Inc. · 1997
- This deviceK020449 Cardionow Cardiology Wide Area Archive and Retrieval SystemCardionow, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924178 | Medvision (TM) Imaging Software | Evergreen Technologies, Inc. | 1993 | — |
| −2 | K970064 | Amicas Web/Intranet Image Server | Autocyt Group, Inc. | 1997 | — |
| −1 | K973131 | Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway) | Siemens Medical Solutions USA, Inc. | 1997 | — |
| 0 (this device) | K020449 | Cardionow Cardiology Wide Area Archive and Retrieval System | Cardionow, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1997 | 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 |
|---|---|---|---|
| * | K973131 | Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway)Summary page 2…CardioNow et Comparisons to Predicate Device The substantially equivalent device is the Siemens ACOM.Web, also marketed as the MagicWeb Cardiac system, FDA 510k number K973131. In reviewing the comparison between CardioNow’s Wide Area Archive and Review System and the predicate device, very little diffe… | 1997 |
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 9 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K973131.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 CardioNow Cardiology Wide Area Archive and Retrieval System is intended to
collect, archive, and display diagnostic information and images. The intent is to
provide long-term archival as well as retrieval of this information to/from Hospital
Site Servers and to provide compressed versions of these images to Internet Web
Clients.
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/K020449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020449: Cardionow Cardiology Wide Area Archive and Retrieval System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020449
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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