# K233444: InkSpace Imaging Small Body Array

- Pathway: 510(k) (Special)
- Applicant: Inkspace Imaging, Inc.
- Decided: Jan 8, 2024 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
Longest line of descent: 6 generations back to K041185 (2004). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223487: InkSpace Imaging Body Array, Inkspace Imaging, Inc. (2022) Summary page 5.

## Most influential descendants
- K253182: InkSpace Imaging Small Body Array (SBA12PH30x) (2025), 0 descendants of its own
- K243675: InkSpace Imaging Small Body Array (2024), 0 descendants of its own

## 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 3.0T 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/K233444
Methodology: https://510kreport.com/methodology