# K221081: iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: First Source, Inc.
- Decided: Jun 13, 2022 after 62 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- 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: 1 generation back to K040046 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040046: Minxray, Model HF120/60H Powerplus, Minxray, Inc. (2004) Summary page 4.

## Recalls of this device
- May 9, 2024 · Class II · Z-2247-2024: Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.

## Indications for use
The iQFlex M/iQFlex MD Mobile X-ray System is a medical device intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities). This device is not intended for mammography.

Source page: https://510kreport.com/device/K221081
Methodology: https://510kreport.com/methodology