# K223487: InkSpace Imaging Body Array

- Pathway: 510(k) (Special)
- Applicant: Inkspace Imaging, Inc.
- Decided: Dec 8, 2022 after 17 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: 5 generations back to K041185 (2004). 5 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K213397: InkSpace Imaging Pediatric Body Array, Inkspace Imaging, Inc. (2021) Summary page 4.

## Most influential descendants
- K233444: InkSpace Imaging Small Body Array (2024), 2 descendants of its own
- 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
Pediatric Population: The Ink:Space Imaging Body Array is a receive-only coil, used for obtaining diagnostic images of pediatric cardiac and body in GE 3.0T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis. Adult Population: The Ink:Space Imaging Body Array is a receive-only coil, used for obtaining diagnostic images of general human anatomy in adults, such as spine, shoulder, elbow, knee, foot, and prostate in GE 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/K223487
Methodology: https://510kreport.com/methodology