# K213351: ds Head 32ch 3.0T

- Pathway: 510(k) (Traditional)
- Applicant: Invivo Corporation (Business Trade Name: Philips)
- Decided: Oct 29, 2021 after 21 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
Longest line of descent: 1 generation back to K082916 (2008). 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)
- K082916: HRB-127-32 High Resolution Brain Coil, Invivo (2008) Summary page 4.

## Indications for use
The dS Head 32ch 3.0T MR Coil is intended to be used in conjunction with a Philips 3.0T Magnetic Resonance Scanner to produce diagnostic images of the head on adult and pediatric patients that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K213351
Methodology: https://510kreport.com/methodology