510(k) · Cleared
ClearedRadAlly
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imaging Wave, LLC · LLZ System, Image Processing, Radiological
Cleared on Mar 31, 2023 as substantially equivalent to K110332 (Clearcanvas, Inc., 2011) after a 494-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Mar 31, 2023
- Review
- 494 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K010259 (2001). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK010259 Mediface PacsMediface Co., Ltd. · 2001
- 5 generations backK012844 Marosis PacsMarotech, Inc. · 2001
- 4 generations backK023460 PacsplusMedical Standard Co., Ltd. · 2003
- 3 generations backK032533 IntelepacsIntelerad Medical Systems, Inc. · 2003
- 2 generations backK070080 IntelepacsIntelerad Medical Systems, Inc. · 2007 · Recalled
- 1 generation backK110332 Clearcanvas Ris / PacsClearcanvas, Inc. · 2011 · Recalled
- This deviceK213660 RadAllyImaging Wave, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010259 | Mediface Pacs | Mediface Co., Ltd. | 2001 | — |
| −5 | K012844 | Marosis Pacs | Marotech, Inc. | 2001 | — |
| −4 | K023460 | Pacsplus | Medical Standard Co., Ltd. | 2003 | — |
| −3 | K032533 | Intelepacs | Intelerad Medical Systems, Inc. | 2003 | — |
| −2 | K070080 | Intelepacs | Intelerad Medical Systems, Inc. | 2007 | 2 |
| −1 | K110332 | Clearcanvas Ris / Pacs | Clearcanvas, Inc. | 2011 | 1 |
| 0 (this device) | K213660 | RadAlly | Imaging Wave, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K110332 | Clearcanvas Ris / PacsSummary page 4…II Product Code: LLZ Panel: Radiology III. Predicate Device Clear Canvas, cleared under K110332, Class II device This product has not been subject to a recall. IV. Device Description: RadAl… | 2011 |
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 22 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 2 other devices also cite its predicate K110332.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
RadAlly™ is a software Medical Image Management and Processing System (MIMPS) intended to transfer, display, archive, and review medical images in DICOM format for diagnostic use by a licensed practitioner, such as a radiologist or any physician maintaining the correct licensing criteria to read and interpret medical images. RadAlly™ supports multimodality imaging such as Ultrasound (US), Digitized X-Ray Film (SC), Digital Radiography (DR), Computed…
Read the full statement (178 words)
RadAlly™ is a software Medical Image Management and Processing System (MIMPS) intended to transfer, display, archive, and review medical images in DICOM format for diagnostic use by a licensed practitioner, such as a radiologist or any physician maintaining the correct licensing criteria to read and interpret medical images. RadAlly™ supports multimodality imaging such as Ultrasound (US),
Digitized X-Ray Film (SC), Digital Radiography (DR), Computed Radiography (CR), Computed Tomography (CT),
Magnetic Resonance (MR) Imaging. RadAlly™ is not intended for use with mammography – either film or full field
digital mammography (FFDM) or tomosynthesis (Tomo or 3D Mammo). It is also not intended for use with nuclear
medicine, PET, SPECT or CT fusion imaging.
RadAlly™ is not indicated for use on mobile displays. RadAlly™ may be interfaced with other DICOM modalities or
MIMPS systems. All pertinent patient information may be displayed simultaneously. The viewer includes standard image
measurement tools such as distance. RadAlly™ also includes manual measurement tools for use with ultrasound cardiac
imaging, including Pressure-Half Time (PHT), Velocity-Time Integral (VTI), Aortic Valve Area (AVA) and Mitral Valve
Area (MVA).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213660: RadAlly.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213660
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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