510(k) · Cleared
ClearedHOLOSCOPE-i
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Real View Imaging, Ltd. · LLZ System, Image Processing, Radiological
Cleared on May 14, 2021 as substantially equivalent to K193149 (Echopixel, Inc., 2019) after a 123-day review. Its family tree reaches back 1 generation to 2019. 4 later devices descend from it.
- Decided
- May 14, 2021
- Review
- 123 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K193149 (2019). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK193149 True 3D Viewer SoftwareEchopixel, Inc. · 2019
- This deviceK210072 HOLOSCOPE-iReal View Imaging, Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK223125 XR90 (XR90-Sys)Mediview Xr, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK221796 Cyware 4H and Cysart 4HAbys Medical · 2022
- Descendant · 2 generations on · 0 of its ownK253486 SKIA-Head (Model: SKIA-ST00)Skia, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK243069 Lumys (V1)Intradys · 2025
Most influential descendants
Showing 4 of 4 · See all- K223125XR90 (XR90-Sys)Mediview Xr, Inc. · 2023 · cites it directly1descendant
- K221796Cyware 4H and Cysart 4HAbys Medical · 2022 · cites it directly1descendant
- K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc. · 2026 · 2 generations on0descendants
- K243069Lumys (V1)Intradys · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K193149 | True 3D Viewer Software | Echopixel, Inc. | 2019 | — |
| 0 (this device) | K210072 | HOLOSCOPE-i | Real View Imaging, Ltd. | 2021 | — |
| +1 | K223125 | XR90 (XR90-Sys) | Mediview Xr, Inc. | 2023 | — |
| +1 | K221796 | Cyware 4H and Cysart 4H | Abys Medical | 2022 | — |
| +2 | K253486 | SKIA-Head (Model: SKIA-ST00) | Skia, Inc. | 2026 | — |
| +2 | K243069 | Lumys (V1) | Intradys | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K193149 | True 3D Viewer SoftwareSummary page 4…cal Product Code: LLZ Device Class: II Regulation Number: 892.2050 Panel: Radiology Predicate Device: K193149 - EchoPixel True 3D Viewer Software Reference Device: K132165 - Philips QLAB Quantification (MVN) Software Intended U… | 2019 |
| † | K132165 | Qlab Quantification Software | 2013 |
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?
- Its one ancestor has no recall.
- Of its descendants, K223125 (Mediview Xr, Inc., 2023) 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. 2021, 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?
The HOLOSCOPE-i is a medical display workstation intended for 3D image visualization and image interaction. The holograms are generated from 3D volumetric data acquired from CT and Ultrasound sources. The device is intended to provide visual information to be used by the health care professional for analysis of surgical options, and the intraoperative display of the images. The HOLOSCOPE-i is intended to be used as an adjunct to the interpretation of…
Read the full statement (111 words)
The HOLOSCOPE-i is a medical display workstation intended for 3D image visualization and image interaction. The holograms are generated from 3D volumetric data acquired from CT and Ultrasound sources. The device is intended to provide visual information to be used by the health care professional for analysis of surgical options, and the intraoperative display of the images. The HOLOSCOPE-i is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis. The HOLOSCOPE-i is intended to be used as a reference display for consultation to assist the clinician who is responsible for making all final patient management decisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210072 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210072: HOLOSCOPE-i.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210072
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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