510(k) · Cleared
ClearedLife Imaging Systems, Model L3DI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Imaging Systems, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on May 20, 1999 as substantially equivalent to K961403 (Life Imaging Systems, Inc., 1996) after an 87-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- May 20, 1999
- Review
- 87 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961403 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK961403 Life Imaging Systems Lis 6000 aLife Imaging Systems, Inc. · 1996
- This deviceK990560 Life Imaging Systems, Model L3DILife Imaging Systems, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961403 | Life Imaging Systems Lis 6000 a | Life Imaging Systems, Inc. | 1996 | — |
| 0 (this device) | K990560 | Life Imaging Systems, Model L3DI | Life Imaging Systems, Inc. | 1999 | — |
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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K961403 | Life Imaging Systems Lis 6000 aSummary page 1…rasound Image Analysis System Classification Name: System, Image Processing Proprietary Name: Life Imaging Systems L3Di Predicate Device Life Imaging Systems LIS 6000A K961403 Device Description The Life Imaging Systems L3Di is a high performance computer system based on Apple Computer and Windows NT s… | 1996 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K961403.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The Life Imaging Systems L3Di is indicated for acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing such as distance, area, volume and angle measurements. It is an add-on accessory for existing ultrasound imaging systems, and is intended to record position and…
Read the full statement (109 words)
The Life Imaging Systems L3Di is indicated for acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing such as distance, area, volume and angle measurements. It is an add-on accessory for existing ultrasound imaging systems, and is intended to record position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. It is intended as a general purpose digital 3D ultrasound image processing tool for radiology, neurology, gastroenterology, urology, surgery, orthopedics, oncology, cardiology, obstetrics and gynecology.
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/K990560 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990560: Life Imaging Systems, Model L3DI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990560
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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