# K162670: RSM 1824C with RConsole1

- Pathway: 510(k) (Traditional)
- Applicant: DRTECH Corporation
- Decided: Feb 23, 2017 after 150 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K896095 (1990). 12 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P010025: Lorad Digital Breast Imager, Hologic, Inc. (2002) Summary page 5.
- K152172: Econsole1, DRTECH Corporation (2015) Summary page 5.

## Most influential descendants
- K202902: 2430MCA with Xmaru W (2021), 1 descendant of its own
- K170930: RSM 2430C (2017), 1 descendant of its own
- K243849: 2430TCA with Xmaru W (2025), 0 descendants of its own
- K241113: Vivix-M (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K162670
Methodology: https://510kreport.com/methodology