# K972766: Pivoting Compensating Filters for the Head

- Pathway: 510(k) (Traditional)
- Applicant: Octostop, Inc.
- Decided: Aug 14, 1997 after 21 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913659 (1992). 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)
- K913659: Little Prism, Octostop, Inc. (1992) Summary page 2.

## Indications for use
I DECLEAR THAT THE PIVOTING COMPENSATION FILTER FOR THE HEAD IS FOR ROTATIONAL examinations of digital and dsa cerebral arteriograms and is substantially equivlent to previously accepted device Little Prism K913659C.

Source page: https://510kreport.com/device/K972766
Methodology: https://510kreport.com/methodology