HC150 - 1.5T Head Coil Lower

GUDID 00857534006134

LOWER ASSEMBLY, 1.5T IOHv2, SAE, 118995-000

DEERFIELD IMAGING, INC.

MRI system coil, radio-frequency

• Primary Device ID: 00857534006134
• NIH Device Record Key: 5073364a-0bec-44cf-ab67-2f09bf1d9470
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HC150 - 1.5T Head Coil Lower
• Version Model Number: HC150 Lower Coil
• Company DUNS: 079990922
• Company Name: DEERFIELD IMAGING, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857534006134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103506

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-05
• Device Publish Date: 2016-09-12

On-Brand Devices [HC150 - 1.5T Head Coil Lower]

• 00857534006448: LOWER ASSEMBLY, 1.5T IOHv2, SAE, 118995-600
• 00857534006134: LOWER ASSEMBLY, 1.5T IOHv2, SAE, 118995-000