# K081340: Pediatric Body and Cardiac Coil, Model 01000140201

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Chenguang Medical Technologies Co, Ltd.
- Decided: Jun 18, 2008 after 36 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: 2 generations back to K041185 (2004). 2 ancestors in all.
6 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)
- K063513: Echelon MR-RCC-150 Cardiac Coil, Hitachi Medical Systems America, Inc. (2006) Summary page 1.
- (no number) Model PHS-63 Pediatric Head Spine Array Coil: named in the summary without a submission number

## Most influential descendants
- K101949: Pediatric Body-Cardiac Coil, Model: 5000012601 (2010), 5 descendants of its own
- K213397: InkSpace Imaging Pediatric Body Array (2021), 4 descendants of its own
- 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

## Indications for use
The Pediatric Body-Cardiac Coil is a receive-only coil, used for obtaining diagnostic images of pediatric cardiac and body in Philips Achieva 1.5T magnetic resonance imaging systems. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.

Source page: https://510kreport.com/device/K081340
Methodology: https://510kreport.com/methodology