# K011608: Model 235GE-64; Multi Purpose Flex Array Coil

- Pathway: 510(k) (Traditional)
- Applicant: Medical Advances, Inc.
- Decided: Aug 14, 2001 after 81 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.
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 no predicate by number.

## Indications for use
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the Head: Temporal lobes (hippocampus), internal auditory canals, orbits and anterior optic pathways, cranial nerves, intracranial magnetic resonance angiography (MRA). Upper Neck: Skull base, Cranio-cervical junction, cervical carotid artery. Upper Extremities: Shoulder, acromioclavicular (AC) joint, elbow, peripheral nerves. Lower Extremities: Knee, ankle and Achilles tendon, foot. Pediatric applications.

Source page: https://510kreport.com/device/K011608
Methodology: https://510kreport.com/methodology