510(k) · Cleared
ClearedFeel-DRCS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imfou Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Sep 15, 2011 as substantially equivalent to K091364 (Oehm Und Rehbein GmbH, 2009) after a 253-day review. Its family tree reaches back 7 generations to 1990. 16 later devices descend from it.
- Decided
- Sep 15, 2011
- Review
- 253 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K896095 (1990). 9 ancestors in all. 16 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 6 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 5 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 4 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 3 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 2 generations backK070618 Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007
- 1 generation backK091364 Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH · 2009
- This deviceK110033 Feel-DRCSImfou Co., Ltd. · 2011
- Descendant · cites it directly · 6 of its ownK152172 Econsole1DRTECH Corporation · 2015
- Descendant · 2 generations on · 4 of its ownK162670 RSM 1824C with RConsole1DRTECH Corporation · 2017
- Descendant · cites it directly · 3 of its ownK231225 EConsole1DRTECH Corporation · 2023
- Descendant · cites it directly · 2 of its ownK123650 Arix Rad Acquisition ConsoleCompania Mexicana DE Radiologia Cgr, S.A. DE C.V. · 2013
- Descendant · 3 generations on · 1 of its ownK202902 2430MCA with Xmaru WRayence Co., Ltd. · 2021
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K152172Econsole1DRTECH Corporation · 2015 · cites it directly6descendants
- K162670RSM 1824C with RConsole1DRTECH Corporation · 2017 · 2 generations on4descendants
- K231225EConsole1DRTECH Corporation · 2023 · cites it directly3descendants
- K123650Arix Rad Acquisition ConsoleCompania Mexicana DE Radiologia Cgr, S.A. DE C.V. · 2013 · cites it directly2descendants
- K2029022430MCA with Xmaru WRayence Co., Ltd. · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −6 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −5 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −4 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −3 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −2 | K070618 | Dicompacs, Model 5 | Oehm Und Rehbein GmbH | 2007 | — |
| −1 | K091364 | Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4 | Oehm Und Rehbein GmbH | 2009 | — |
| 0 (this device) | K110033 | Feel-DRCS | Imfou Co., Ltd. | 2011 | — |
| +1 | K152172 | Econsole1 | DRTECH Corporation | 2015 | — |
| +2 | K162670 | RSM 1824C with RConsole1 | DRTECH Corporation | 2017 | — |
| +1 | K231225 | EConsole1 | DRTECH Corporation | 2023 | — |
| +1 | K123650 | Arix Rad Acquisition Console | Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. | 2013 | — |
| +3 | K202902 | 2430MCA with Xmaru W | Rayence Co., Ltd. | 2021 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 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 |
|---|---|---|---|
| * | K091364 | Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Summary page 2…" technological characteristics. " performance properties aePredicate Prdc device (K091364) New device Prodct amedicomPACS DX-R 1.6… | 2009 |
What descends from it? (16)
See all 164 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 21 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K152172 (DRTECH Corporation, 2015) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K091364.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
feel-DRCS software, used together with digital X-ray detector is the digital X-ray image processing system designed for acquiring images and processing acquired images efficiently. The main features of this software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, optimizing window level and width of acquired images, rotating images, zooming images, measuring images and other features…
Read the full statement (131 words)
feel-DRCS software, used together with digital X-ray detector is the digital X-ray image processing system designed for acquiring images and processing acquired images efficiently.
The main features of this software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, optimizing window level and width of acquired images, rotating images, zooming images, measuring images and other features used for imaging processing.
feel-DRCS is compatible with DICOM 3.0 standard. It can transfer images processed in PACS and print images with a film printer compatible with DICOM 3.0 by using DICOM and network systems.
feel-DRCS is not approved for the acquisition of mamnmographic image data and is meant to be used by qualified medical personnel only. All users must be qualified to create and diagnose radiological image data.
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/K110033 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110033: Feel-DRCS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110033
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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