# K082916: HRB-127-32 High Resolution Brain Coil

- Pathway: 510(k) (Special)
- Applicant: Invivo
- Decided: Oct 15, 2008 after 15 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.
- (no number) Model HRH-127-8 Head Array Coil: named in the summary without a submission number

## Most influential descendants
- K213351: ds Head 32ch 3.0T (2021), 0 descendants of its own

## Indications for use
The coil is indicated for use, on the order of a physician, in conjunction with an MR scanner as an accessory to produce images of the anatomy of interest, as an aid to diagnosis / treatment.

Source page: https://510kreport.com/device/K082916
Methodology: https://510kreport.com/methodology