# K241980: !M1

- Pathway: 510(k) (Traditional)
- Applicant: Solutions For Tomorrow AB
- Decided: May 6, 2025 after 305 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K981556 (1998). 54 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170607: !M1, Solutions For Tomorrow AB (2017) Summary page 6.
- K113248: Aerodr System with P-21, Konica Minolta Medical & Graphic, Inc. (2012) Summary page 8.
- K130936: Aerodr System with P-31, Konica Minolta Medical & Graphic, Inc. (2013) Summary page 8.
- K141271: Aerodr System 2, Konica Minolta, Inc. (2014) Summary page 8.
- K162504: SKR 3000, Konica Minolta, Inc. (2016) Summary page 8.
- K133693: Digital Radiography Cxdi-401C Wireless, Canon, Inc. (2014) Summary page 8.
- K131106: Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG Wireless, Digital Radiography Cxdi-801C Wireless,, Canon, Inc. (2013) Summary page 8.
- K221512: Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW), Vieworks Co., Ltd. (2022) Summary page 10.
- K200418: Vivix-S VW, Vieworks Co., Ltd. (2020) Summary page 10.

## Most influential descendants
- K251710: Mobile X-ray unit (!M1) (2025), 0 descendants of its own

## Indications for use
The device is designed to perform general radiography x-ray examinations on all pediatric and all adult patients, in all patient treatment areas. Treatment areas are defined as professional health care facility environments where operators with medical training are continually present during patients' examinations.

Source page: https://510kreport.com/device/K241980
Methodology: https://510kreport.com/methodology