# K993896: Mca-601, C-Arm Mobile

- Pathway: 510(k) (Traditional)
- Applicant: Medison Radiology Systems, Inc.
- Decided: Mar 27, 2000 after 132 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K032761: KMC-950 C-Arm Mobile System (2004), 14 descendants of its own
- K160279: ANYVIEW-500R Fluoroscopic Mobile X-Ray System (2016), 9 descendants of its own
- K191503: MobileRay Pulse SE Digital Imaging System (2019), 7 descendants of its own
- K211191: Virtual C DRF Digital Imaging System (2021), 5 descendants of its own
- K241567: MC2 Portable X-ray System (2024), 1 descendant of its own

## Indications for use
The MCA-601, C-Arm Moabile is used for providing fluoroscopic and radiographic images of patient anatomy, especially during special procedures in a hospital or medical clinics. The fluoroscopic mode of operation is very useful to the attending physician to see the images in real time without the need to develop individual films.

Source page: https://510kreport.com/device/K993896
Methodology: https://510kreport.com/methodology