Silhouette Adult Array

GUDID 00860008041319

The InkSpace Imaging Silhouette Adult Array is a phased array, receive-only coil designed to work on Siemens 3.0 Tesla (3.0T) MRI scanners. It consists of 24 elements which are optimized to be lightweight and flexible to easily conform to a patient’s anatomy, providing high signal-to-noise ratio. It includes two identical pads, which each contain 12 elements. The two pads can be positioned separately, such that setup time is minimized.

Inkspace Imaging, Inc.

MRI system coil, radio-frequency

• Primary Device ID: 00860008041319
• NIH Device Record Key: 26169390-ad88-42ae-b455-e591a0cabc5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silhouette Adult Array
• Version Model Number: SBA24SH30C
• 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: false
• 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	00860008041319 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233444

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: 2024-02-16
• Device Publish Date: 2024-02-08

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: 2024-02-16The InkSpace Imaging Silhouette Adult Array is a phased array, receive-only coil designed to work on Siemens 3.0 Tesla (3.0T) MRI scanners. It consists of 24 elements which are optimized to be lightweight and flexible to easily conform to a patient’s anatomy, providing high signal-to-noise ratio. It includes two identical pads, which each contain 12 elements. The two pads can be positioned separately, such that setup time is minimized.
• 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: 2023-03-20 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