# K964813: Model 675GE-64 Peripheral Vascular Coil Consisting of Model 665GE-64: Lower Extremity Flexible Array and Model 538GE-64:

- Pathway: 510(k) (Traditional)
- Applicant: Medical Advances, Inc.
- Decided: Feb 26, 1997 after 89 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices 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.

## Most influential descendants
- K982339: Flow 7000 Peripheral Vascular Coil (1998), 2 descendants of its own
- K023247: Champion 5000 Peripheral Vascular Coil (2002), 1 descendant of its own
- K042207: 11000 Rapture Phased Array Peripheral Vascular Coil (2004), 0 descendants of its own

## Indications for use
2D, 3D imaging, proton density, T1 and T2 weighted imaging. 2D, 3D time of flight, phase contrast imaging. Vascular structures, soft tissue and musculosketeal structures in the lower extremities (mid-abdomen to mid-foot)

Source page: https://510kreport.com/device/K964813
Methodology: https://510kreport.com/methodology