510(k) · Cleared
Clearedi-Rapha Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Irm, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jul 9, 2020 as substantially equivalent to K152977 (Dicom Grid, Inc., 2016) after a 55-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Jul 9, 2020
- Review
- 55 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K954678 (1996). 24 ancestors in all, the oldest K913475 (1991). No later device cites it as a predicate yet.
- Root · 7 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 5 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 4 generations backK012097 VortexUltravisual Medical Systems · 2001
- 3 generations backK061421 Erad PacsErad, Inc. · 2006
- 2 generations backK120995 Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc. · 2012
- 1 generation backK152977 DG PacsDicom Grid, Inc. · 2016 · Recalled
- This deviceK201296 i-Rapha SolutionIrm, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −6 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −5 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −4 | K012097 | Vortex | Ultravisual Medical Systems | 2001 | — |
| −3 | K061421 | Erad Pacs | Erad, Inc. | 2006 | — |
| −2 | K120995 | Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software Product | Erad, Inc. | 2012 | — |
| −1 | K152977 | DG Pacs | Dicom Grid, Inc. | 2016 | 1 |
| 0 (this device) | K201296 | i-Rapha Solution | Irm, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 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 |
|---|---|---|---|
| * | K152977 | DG PacsSummary page 4…Product Code Name System, Image Processing, Radiological 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)] - 510(k) Number: K152977 - Applicant: DICOM Grid, Inc. - Regulation Name: Picture archiving and communications system - Product Cod… | 2016 |
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 24 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 3 of the 24 ancestors have a recall of any class.
- 1 other device also cites its predicate K152977.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
i-Rapha Solution is intended for use as a primary diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists and any user who requires and is granted access to patient image, demographic.
i-Rapha View, a component of i-Rapha Solution, displays and manages diagnostic quality DICOM images.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201296: i-Rapha Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201296
Report an extraction error
Are you the manufacturer?
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