510(k) · Cleared
ClearedDyna Vue 3-D Imaging Product
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imd Systems, Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 4, 1998 after a 75-day review. The FDA summary names its predicate without a number.
- Decided
- Mar 4, 1998
- Review
- 75 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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
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- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | Voxel System manufactured by Voxel Digital Holography Named without a submission number | |
| * | — | Endolive System (3 D Endoscope) produced by Carl Zeiss Germany Named without a submission number |
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.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
This device will be used in the same manner as all three dimensional imaging products are used, similar to the Voxel System. It can be used with any two and three dimensional spinning image data such as MRI, CAT, DSA and Ultrasound produced data and converts the data into complete and real 3D images in rotational and static fashion. The device is used to aid the surgeon by permitting more precise morphological diagnosis especially in aneurysms…
Read the full statement (207 words)
This device will be used in the same manner as all three dimensional imaging products are used, similar to the Voxel System. It can be used with any two and three dimensional spinning image data such as MRI, CAT, DSA and Ultrasound produced data and converts the data into complete and real 3D images in rotational and static fashion. The device is used to aid the surgeon by permitting more precise morphological diagnosis especially in aneurysms, atherosclerotic lesions and bile duct carcinomas due to the improved view of the data. It may also facilitate highly selective interventional procedures for vascular surgeons because of the improved three dimensional vascular road map the physician sees. The system does not take the place of the physician it is only a tool to assist the physician in his diagnosis, it does not make the diagnosis for him. Decisions about what to do and how to perform a procedure rest firmly with the physician.
This device is used primarily by physicians and health care workers, and is normally used under the supervision of a physician. It is not sold to the general public but may be available as a teaching tool to Universities and Medical Schools without the requirement of physician supervision.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974755: Dyna Vue 3-D Imaging Product.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974755
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026