# K210309: Cios Select (VA21) Flat Panel

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 5, 2021 after 30 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K801623 (1980). 78 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181767: Cios Select, Siemens Medical Solutions USA, Inc. (2018) Summary page 4.
- K181550: Cios Spin, Siemens Medical Solutions USA, Inc. (2018) Summary page 5.
- K203504: Cios Flow, Siemens Medical Solutions USA, Inc. (2020) Summary page 5.

## Most influential descendants
- K223410: Cios Select (VA21) Flat Panel (2022), 1 descendant of its own
- K250241: Cios Select (2025), 0 descendants of its own

## Recalls of this device
- Jun 5, 2023 · Class II · Z-2240-2023: Incorrect glue was applied on the plexiglass sheet on the single tank cover assembly could potentially fall off and the ingress of liquid may occur, the risk of electric shock exists (e.g., ingress of

## Indications for use
The Cios Select is a mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. The Cios Select can operate in three different modes, Digital Radiography, Fluoroscopy, and Pulsed Fluoroscopy which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of an intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

Source page: https://510kreport.com/device/K210309
Methodology: https://510kreport.com/methodology