# K213397: InkSpace Imaging Pediatric Body Array

- Pathway: 510(k) (Traditional)
- Applicant: Inkspace Imaging, Inc.
- Decided: Dec 17, 2021 after 60 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: 4 generations back to K041185 (2004). 4 ancestors in all.
4 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)
- K101949: Pediatric Body-Cardiac Coil, Model: 5000012601, Shanghai Chenguang Medical Technologies Co, Ltd. (2010) Summary page 4.

## Most influential descendants
- K223487: InkSpace Imaging Body Array (2022), 3 descendants of its own
- 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
The Ink:Space Imaging Pediatric 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.

Source page: https://510kreport.com/device/K213397
Methodology: https://510kreport.com/methodology