# K970090: Solo-Sled

- Pathway: 510(k) (Traditional)
- Applicant: Solo-Sled, LLC
- Decided: Apr 21, 1997 after 101 days
- Product code: IXA (Cassette, Radiographic Film)
- Device class: 2
- Regulation: 21 CFR 892.1850
- 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) Radiographic Film Cassette: named in the summary without a submission number

## Indications for use
Solo-Sled is a device designed to allow one staff member to be able to position 14 x 17 cassettes behind ehest and/or under the back of a patient without causing pain to the patient in lifting or moving them. Solo-Sled will allow positioning of cassettes without requiring two to three staff members to lift the patient once to place the cassette and then the second time to remove the cassette. The device is an accessory to a 14 x 17 radiographic film cassette.

Source page: https://510kreport.com/device/K970090
Methodology: https://510kreport.com/methodology