# K243675: InkSpace Imaging Small Body Array

- Pathway: 510(k) (Special)
- Applicant: Inkspace Imaging, Inc.
- Decided: Dec 20, 2024 after 23 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: 7 generations back to K041185 (2004). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233444: InkSpace Imaging Small Body Array, Inkspace Imaging, Inc. (2024) Summary page 6.

## Indications for use
The InkSpace Imaging Small Body Array is a receive-only coil, used for obtaining diagnostic images of general human anatomy in adult and pediatric patients such as cardiac, spine, shoulder, elbow, knee, foot, and prostate in Siemens 1.5T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K243675
Methodology: https://510kreport.com/methodology