# K220073: RMF-2000

- Pathway: 510(k) (Traditional)
- Applicant: DRTECH Corporation
- Decided: Jan 26, 2023 after 381 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: 2 generations back to P990066 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110798: Senographe DS, Senographe Essential, General Electric Company (2011) Summary page 5.

## Most influential descendants
- K254092: Bellalun 2D (VDMS-1000S) (2026), 0 descendants of its own

## Indications for use
The RMF-2000 generates 2D digital mammography images. The RMF-2000 is intended to be used for screening and diagnosis of breast cancer. This unit is intended for use in the same clinical applications as traditional screen film mammography systems.

Source page: https://510kreport.com/device/K220073
Methodology: https://510kreport.com/methodology