510(k) · Cleared
ClearedThe Obsidian Pacs System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Obsidian Medical Technology, Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 28, 2003 as substantially equivalent to K013088 (Echotech 3D Imaging Systems, Inc., 2002) after a 28-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Mar 28, 2003
- Review
- 28 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K941322 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK941322 Echo-ScanTomographic Tech · 1995
- 3 generations backK963807 Tomtec Echo-ScanTomtec Imaging Systems, Inc. · 1996
- 2 generations backK980308 Echotech 3D FreescanEchotech 3D Imaging Systems GmbH · 1998
- 1 generation backK013088 Echotech Easy 3D Family, Echotech 3D Freescan, Echotech Easyarchive…Echotech 3D Imaging Systems, Inc. · 2002
- This deviceK030635 The Obsidian Pacs SystemObsidian Medical Technology, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK031567 3D Invivo by CsistChung-Shan Institute of Science and Technology · 2003
Most influential descendants
Showing 1 of 1 · See all- K0315673D Invivo by CsistChung-Shan Institute of Science and Technology · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941322 | Echo-Scan | Tomographic Tech | 1995 | — |
| −3 | K963807 | Tomtec Echo-Scan | Tomtec Imaging Systems, Inc. | 1996 | — |
| −2 | K980308 | Echotech 3D Freescan | Echotech 3D Imaging Systems GmbH | 1998 | — |
| −1 | K013088 | Echotech Easy 3D Family, Echotech 3D Freescan, Echotech Easyarchive, Echotech… | Echotech 3D Imaging Systems, Inc. | 2002 | — |
| 0 (this device) | K030635 | The Obsidian Pacs System | Obsidian Medical Technology, Inc. | 2003 | — |
| +1 | K031567 | 3D Invivo by Csist | Chung-Shan Institute of Science and Technology | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 |
|---|---|---|---|
| * | K013088 | Echotech Easy 3D Family, Echotech 3D Freescan, Echotech Easyarchive, Echotech Quanticon… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031567 | 3D Invivo by Csist | 2003 | 0 |
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 8 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K031567 (Chung-Shan Institute of Science and Technology, 2003) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K013088.
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?
The Obsidian PACS System is used to acquire, transmit, view, and store image or patient data. This data can be transmitted, stored, and viewed over a computer network or off-site using an Internet connection. The typical users of this system are trained professionals, including but not limited to, radiologist, physicians, technicians, and nurses.
The 3D Ultrasound Image Router is indicated for capture and storage of 2D images from an ultrasound system and reconstructing them into 3D ultrasound images. These images provide an approximate representation of the 3D volume for use in obstetric exams. The 3D images are not intended for use in diagnosis or quantitative measurements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030635 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030635: The Obsidian Pacs System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030635
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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