InkSpace Imaging Body Array

GUDID 00860008041340

The InkSpace Imaging Body Array is a phased array, receive-only coil intended to work with GE 3.0T MRI scanners to provide optimal signal-to-noise ratio and uniformity for high resolution body MR imaging examinations. The size and layout of individual channels of the InkSpace Imaging Body Array were designed specifically to fit body imaging. The coil is comprised of 24 total channels, with two individual flexible pads, intended to be placed anterior and posterior to the patient, containing 12 individual elements. The elements are optimized to be flexible to conform to a pediatric patient’s anatomy.

Inkspace Imaging, Inc.

MRI system coil, radio-frequency

• Primary Device ID: 00860008041340
• NIH Device Record Key: 1b630cb9-a348-4b50-8830-3a00881a3585
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InkSpace Imaging Body Array
• Version Model Number: PBA24GE30B
• Company DUNS: 080330758
• Company Name: Inkspace Imaging, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008041340 [Primary]

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-20
• Device Publish Date: 2023-03-10

Devices Manufactured by Inkspace Imaging, Inc.

• 00860008041302 - Snuggle Pediatric Array: 2024-02-16 The InkSpace Imaging Snuggle Pediatric Array is a phased array, receive-only coil designed to work on Siemens 3.0 Tesla (3.0T) M
• 00860008041319 - Silhouette Adult Array: 2024-02-16 The InkSpace Imaging Silhouette Adult Array is a phased array, receive-only coil designed to work on Siemens 3.0 Tesla (3.0T) MR
• 00860008041340 - InkSpace Imaging Body Array: 2023-03-20The InkSpace Imaging Body Array is a phased array, receive-only coil intended to work with GE 3.0T MRI scanners to provide optimal signal-to-noise ratio and uniformity for high resolution body MR imaging examinations. The size and layout of individual channels of the InkSpace Imaging Body Array were designed specifically to fit body imaging. The coil is comprised of 24 total channels, with two individual flexible pads, intended to be placed anterior and posterior to the patient, containing 12 individual elements. The elements are optimized to be flexible to conform to a pediatric patient’s anatomy.
• 00860008041340 - InkSpace Imaging Body Array: 2023-03-20 The InkSpace Imaging Body Array is a phased array, receive-only coil intended to work with GE 3.0T MRI scanners to provide optim
• 00860008041326 - Pediatric Body Array: 2022-02-18 The InkSpace Imaging Pediatric Body Array is a phased array, receive-only coil intended to work with GE 3.0T MRI scanners to pro