510(k) · Cleared
ClearedInstaRISPACS / InstaZFP / InstaMobi v5.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meddiff Technologies Pvt., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Apr 12, 2019 after a 206-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Apr 12, 2019
- Review
- 206 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK182572 InstaRISPACS / InstaZFP / InstaMobi v5.0Meddiff Technologies Pvt., Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK212984 MiPACS HTML5 Web ViewerLead Technologies, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK211863 eVolve PACSEvolve Pacs, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK260231 MiPACS V5 (1.0.0)Apryse Software Corp · 2026
- Descendant · 2 generations on · 0 of its ownK232641 Neorad Pacs (Neorad Pacs)Everrtech Software Pvt, Ltd. · 2024
Most influential descendants
Showing 4 of 4 · See all- K212984MiPACS HTML5 Web ViewerLead Technologies, Inc. · 2021 · cites it directly1descendant
- K211863eVolve PACSEvolve Pacs, Inc. · 2021 · cites it directly1descendant
- K260231MiPACS V5 (1.0.0)Apryse Software Corp · 2026 · 2 generations on0descendants
- K232641Neorad Pacs (Neorad Pacs)Everrtech Software Pvt, Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K182572 | InstaRISPACS / InstaZFP / InstaMobi v5.0 | Meddiff Technologies Pvt., Ltd. | 2019 | — |
| +1 | K212984 | MiPACS HTML5 Web Viewer | Lead Technologies, Inc. | 2021 | — |
| +1 | K211863 | eVolve PACS | Evolve Pacs, Inc. | 2021 | — |
| +2 | K260231 | MiPACS V5 (1.0.0) | Apryse Software Corp | 2026 | — |
| +2 | K232641 | Neorad Pacs (Neorad Pacs) | Everrtech Software Pvt, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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?
The FDA summary names no predicate by number.
What descends from it? (4)
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?
- Of its descendants, K212984 (Lead Technologies, Inc., 2021) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 | — |
https://510kreport.com/device/K182572 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182572: InstaRISPACS / InstaZFP / InstaMobi v5.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182572
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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