# K981466: XR-910

- Pathway: 510(k) (Traditional)
- Applicant: Imaging Sciences Intl., Inc.
- Decided: Jul 14, 1998 after 82 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DynaRad Corporation Phantom Portable X-Ray system: named in the summary without a submission number

## Indications for use
The XR-910 folds into a compact unit (20" W 54.5" L 21" H). The XR-910 is then easily transported by a van or similar vehicle, to a private residence, nursing home, medical clinic, and other such facilities. With the large 15" pneumatic wheels, and 20" wheelbase and a weight of only 78 Ibs., the XR-910 can be easily maneuvered through doorways, hallways, and up and down flights of stairs. This can be accomplished by an dverage person. Due to the large vertical movement of the tubehead and boom arm, and rotational positions of the tubehead, radiographs may be taken with the patient standing, sitting or supine. Radiographs may be taken of the chest and extremities. The XR-910 is a 60 to 90 kVp, 10 mA unit. Using 800 speed film and screens, exposure times for most radiographs are less than 100 milliseconds.

Source page: https://510kreport.com/device/K981466
Methodology: https://510kreport.com/methodology