510(k) · Cleared
ClearedRSM 1824C with RConsole1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DRTECH Corporation · MUE Full Field Digital, System, X-Ray, Mammographic
Cleared on Feb 23, 2017 as substantially equivalent to P010025 (Hologic, Inc., 2002) and 1 other predicate after a 150-day review. Its family tree reaches back 9 generations to 1990. 4 later devices descend from it.
- Decided
- Feb 23, 2017
- Review
- 150 days
- Class
- Class II
- Product code
- MUE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K896095 (1990). 12 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 5 generations between
- 3 generations backK091364 Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH · 2009
- 2 generations backK110033 Feel-DRCSImfou Co., Ltd. · 2011
- 1 generation backK152172 Econsole1DRTECH Corporation · 2015
- This deviceK162670 RSM 1824C with RConsole1DRTECH Corporation · 2017
- Descendant · cites it directly · 1 of its ownK202902 2430MCA with Xmaru WRayence Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK170930 RSM 2430CDRTECH Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK243849 2430TCA with Xmaru WRayence Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK241113 Vivix-MVieworks Co., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 8 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 7 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 6 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 5 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 4 generations backK070618 Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007
- 3 generations backK091364 Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH · 2009
- 2 generations backK110033 Feel-DRCSImfou Co., Ltd. · 2011
- 1 generation backK152172 Econsole1DRTECH Corporation · 2015
- This deviceK162670 RSM 1824C with RConsole1DRTECH Corporation · 2017
Most influential descendants
Showing 4 of 4 · See all- K2029022430MCA with Xmaru WRayence Co., Ltd. · 2021 · cites it directly1descendant
- K170930RSM 2430CDRTECH Corporation · 2017 · cites it directly1descendant
- K2438492430TCA with Xmaru WRayence Co., Ltd. · 2025 · 2 generations on0descendants
- K241113Vivix-MVieworks Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −8 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −7 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −6 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −5 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −4 | K070618 | Dicompacs, Model 5 | Oehm Und Rehbein GmbH | 2007 | — |
| −3 | K091364 | Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4 | Oehm Und Rehbein GmbH | 2009 | — |
| −2 | K110033 | Feel-DRCS | Imfou Co., Ltd. | 2011 | — |
| −1 | K152172 | Econsole1 | DRTECH Corporation | 2015 | — |
| 0 (this device) | K162670 | RSM 1824C with RConsole1 | DRTECH Corporation | 2017 | — |
| +1 | K202902 | 2430MCA with Xmaru W | Rayence Co., Ltd. | 2021 | — |
| +1 | K170930 | RSM 2430C | DRTECH Corporation | 2017 | — |
| +2 | K243849 | 2430TCA with Xmaru W | Rayence Co., Ltd. | 2025 | — |
| +2 | K241113 | Vivix-M | Vieworks Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 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 MUE? 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 MUE device
- #1 K253678 MAMMOMAT B.brilliant (11372950)score 13.6 · 8 generations · no Class I recall
- #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 |
|---|---|---|---|
| * | P010025 | Lorad Digital Breast ImagerSummary page 5…Predicate Device(s) [21 CFR 807.92(a) (3)] For Detector For Software • 510(k) Number P010025 K152172 • Applicant HOLOGIC, INC. DRTECH CORPORATI… | 2002 |
| * | K152172 | Econsole1Summary page 5…] For Detector For Software • 510(k) Number P010025 K152172 • Applicant HOLOGIC, INC. DRTECH CORPORATION • Trade Name Lorad Digi… | 2015 |
What descends from it? (4)
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 27 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K202902 (Rayence Co., Ltd., 2021) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MUE devicesMUE Full Field Digital, System, X-Ray, Mammographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MUE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUE
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUE
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUE
40in 2025
MAUDE reports naming product code MUE, 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 | 6 | — | 0 | 0 |
| 2008 | 5 | — | 1 | 4 |
| 2009 | 8 | — | 1 | 3 |
| 2010 | 10 | — | 2 | 2 |
| 2011 | 10 | 192 | 5 | 10 |
| 2012 | 4 | 123 | 0 | 6 |
| 2013 | 7 | 207 | 0 | 11 |
| 2014 | 1 | — | 2 | 7 |
| 2015 | 1 | — | 0 | 6 |
| 2016 | 1 | — | 0 | 19 |
| 2017 | 8 | 95 | 6 | 115 |
| 2018 | 2 | — | 1 | 145 |
| 2019 | 2 | — | 1 | 80 |
| 2020 | 4 | 188 | 0 | 49 |
| 2021 | 4 | 164 | 0 | 25 |
| 2022 | 3 | 404 | 0 | 36 |
| 2023 | 1 | — | 1 | 29 |
| 2024 | 1 | — | 0 | 33 |
| 2025 | 3 | 255 | 4 | 40 |
| 2026 | 4 | 185 | 1 | — |
What is it indicated for?
The RSM 1824C is a detector indicated for use in screening and diagnostic mammography.
The RConsole1 is an integrated software solution indicated for use with the RSM Series detectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162670 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162670: RSM 1824C with RConsole1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162670
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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