510(k) · Cleared
ClearedEconsole1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DRTECH Corporation · LLZ System, Image Processing, Radiological
Cleared on Dec 14, 2015 as substantially equivalent to K110033 (Imfou Co., Ltd., 2011) after a 132-day review. Its family tree reaches back 8 generations to 1990. 6 later devices descend from it.
- Decided
- Dec 14, 2015
- Review
- 132 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K896095 (1990). 10 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 7 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 6 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 5 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 4 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 3 generations backK070618 Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007
- 2 generations backK091364 Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH · 2009
- 1 generation backK110033 Feel-DRCSImfou Co., Ltd. · 2011
- This deviceK152172 Econsole1DRTECH Corporation · 2015
- Descendant · cites it directly · 4 of its ownK162670 RSM 1824C with RConsole1DRTECH Corporation · 2017
- Descendant · 2 generations on · 1 of its ownK202902 2430MCA with Xmaru WRayence Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK170930 RSM 2430CDRTECH Corporation · 2017
- Descendant · cites it directly · 0 of its ownK251038 Digital Radiographic Imaging Acquisition Software - DR (RiasDR)Shen Zhen Cambridge-Hit Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK243849 2430TCA with Xmaru WRayence Co., Ltd. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K162670RSM 1824C with RConsole1DRTECH Corporation · 2017 · cites it directly4descendants
- K2029022430MCA with Xmaru WRayence Co., Ltd. · 2021 · 2 generations on1descendant
- K170930RSM 2430CDRTECH Corporation · 2017 · 2 generations on1descendant
- K251038Digital Radiographic Imaging Acquisition Software - DR (RiasDR)Shen Zhen Cambridge-Hit Co., Ltd. · 2025 · cites it directly0descendants
- K2438492430TCA with Xmaru WRayence Co., Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −7 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −6 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −5 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −4 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −3 | K070618 | Dicompacs, Model 5 | Oehm Und Rehbein GmbH | 2007 | — |
| −2 | K091364 | Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4 | Oehm Und Rehbein GmbH | 2009 | — |
| −1 | K110033 | Feel-DRCS | Imfou Co., Ltd. | 2011 | — |
| 0 (this device) | K152172 | Econsole1 | DRTECH Corporation | 2015 | — |
| +1 | K162670 | RSM 1824C with RConsole1 | DRTECH Corporation | 2017 | — |
| +2 | K202902 | 2430MCA with Xmaru W | Rayence Co., Ltd. | 2021 | — |
| +2 | K170930 | RSM 2430C | DRTECH Corporation | 2017 | — |
| +1 | K251038 | Digital Radiographic Imaging Acquisition Software - DR (RiasDR) | Shen Zhen Cambridge-Hit Co., Ltd. | 2025 | — |
| +3 | K243849 | 2430TCA with Xmaru W | Rayence Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2021 | 1 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K110033 | Feel-DRCSSummary page 4…Product Code: LLZ Device Class: 2 4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)] 510(k) Number: K110033 Product Code: LLZ Applicant: IMFOU CO., LTD Model Name: FEEL-… | 2011 |
What descends from it? (6)
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?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K162670 (DRTECH Corporation, 2017) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K110033.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Econsole1 software is indicated for use in general radiographic images of human anatomy (excluding fluoroscopic, angiographic, and mammographic applications).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152172: Econsole1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152172
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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