# K211473: Micro C Medical Imaging System, M01

- Pathway: 510(k) (Traditional)
- Applicant: Oxos Medical, Inc.
- Decided: Jun 4, 2021 after 23 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: 5 generations back to K945707 (1995). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203658: Micro C Medical Imaging System, M01, Oxos Medical, Inc. (2021) Summary page 4.

## Most influential descendants
- K212654: Micro C Medical Imaging System, M01 (2022), 0 descendants of its own

## Indications for use
The Micro C Medical Imaging System, MO1 is a handheld and portable general purpose X-ray system that is indicated for use by qualified/trained clinicians on adult and pediatric patients for taking diagnostic static and serial radiographic exposures of extremities. The device is not intended to replace a radiographic system that has both variable tube current and voltages (kVp) in the range that may be required for full optimization of image quality and radiation exposure for different exam types.

Source page: https://510kreport.com/device/K211473
Methodology: https://510kreport.com/methodology