510(k) · Cleared
ClearedImagic V2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ashva Technologies, Pvt., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Jul 23, 2007 as substantially equivalent to K062062 (Voyager Imaging, 2006) after a 42-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Jul 23, 2007
- Review
- 42 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K010259 (2001). No later device cites it as a predicate yet.
- Root · 5 generations backK010259 Mediface PacsMediface Co., Ltd. · 2001
- 4 generations backK012844 Marosis PacsMarotech, Inc. · 2001
- 3 generations backK040486 MedipacsNeobit Co., Ltd. · 2004
- 2 generations backK060263 IqpacsS.C. Info World S.R.L. · 2006
- 1 generation backK062062 Voyager Pacs SystemVoyager Imaging · 2006
- This deviceK071602 Imagic V2.0Ashva Technologies, Pvt., Ltd. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010259 | Mediface Pacs | Mediface Co., Ltd. | 2001 | — |
| −4 | K012844 | Marosis Pacs | Marotech, Inc. | 2001 | — |
| −3 | K040486 | Medipacs | Neobit Co., Ltd. | 2004 | — |
| −2 | K060263 | Iqpacs | S.C. Info World S.R.L. | 2006 | — |
| −1 | K062062 | Voyager Pacs System | Voyager Imaging | 2006 | — |
| 0 (this device) | K071602 | Imagic V2.0 | Ashva Technologies, Pvt., Ltd. | 2007 | — |
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 |
|---|---|---|---|
| * | K062062 | Voyager Pacs SystemSummary page 1…uivalent to: Manufacturer: Voyager Imaging Device Name: Voyager PACS Stystem 510(k) Number: K062062 Product Code: LLZ Device Classification Name: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Regu… | 2006 |
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 6 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- None of the 5 ancestors has a recall.
- 4 other devices also cite its predicate K062062.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
iMagic v2.OTM device is software intended for viewing and diagnostic interpretation of images acquired from Ultrasound and other DICOM compliant medical imaging systems (CT, MR, CR, DR), when installed on suitable commercial standard hardware. iMagic v2.OTM receives Ultrasound images and other modality imaging studies over a network from servers, directly from the imaging modality or from an archive (including media) utilizing both lossless (reversible)…
Read the full statement (139 words)
iMagic v2.OTM device is software intended for viewing and diagnostic interpretation of images acquired from Ultrasound and other DICOM compliant medical imaging systems (CT, MR, CR, DR), when installed on suitable commercial standard hardware.
iMagic v2.OTM receives Ultrasound images and other modality imaging studies over a network from servers, directly from the imaging modality or from an archive (including media) utilizing both lossless (reversible) and lossy (irreversible) compression. iMagic v2.0TM does not use lossy (irreversible) compression during image handling, manipulation, or storage.
Only DICOM, for presentation, images will be captured for display and diagnosis.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071602: Imagic V2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071602
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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