# K170858: FDR Aqro (DR-XD 1000)

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Apr 24, 2017 after 33 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K041763 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143537: Sirius Starmobile tiara, Hitachi Medical Systems America, Inc. (2015) Summary page 4.

## Recalls of this device
- Nov 23, 2023 · Class II · Z-3158-2024: When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions a
- Feb 27, 2023 · Class II · Z-1470-2023: Arm which holds the tube head in place is susceptible to breaking, if the device breaks it could potentially cause serious harm or injury to the patient and/or user.

## Indications for use
The FDR AQRO (DR-XD 1000) is a digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. The FDR AQRO is not intended for mammography.

Source page: https://510kreport.com/device/K170858
Methodology: https://510kreport.com/methodology