ECG CT Gating Cable

GUDID 00856181003336

The SynChron™ Wireless Vector Gating System for CT is a product used to acquire electrocardiogram (ECG) data from a patient and to generate and supply ECG waveform and triggering pulses to the CT scanner to aid in cardiac scanning. The SynChron™ Wireless Vector Gating System for CT includes a Physiologic Acquisition Module (PAM) that connects to the patient using ECG lead wires (Figure 2-2), acquires ECG data, processes the ECG data, and wirelessly transmits the data to the Receive Interface Module (RIM). The RIM will wirelessly receive data from the PAM, create analog ECG waveform and trigger pulse mark, and interfaces with the scanner. The ECG waveform and trigger marks can be seen on the scanner console.

NEOCOIL, LLC

Electrocardiograph, professional, multichannel

• Primary Device ID: 00856181003336
• NIH Device Record Key: c1a0a4fb-a462-4d39-8c08-f66f5ea896b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECG CT Gating Cable
• Version Model Number: 33
• Company DUNS: 781155176
• Company Name: NEOCOIL, LLC
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856181003336 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160350

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

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: 2018-07-06
• Device Publish Date: 2017-03-21

Devices Manufactured by NEOCOIL, LLC

• 00850028932490 - 32ch AIR Open Coil Suite, 3.0T: 2025-05-26 The 32Ch AIR Open Coil Suite is comprised of MRI receive-only phased array RF coils designed for clinically acceptable signal-to
• 00850028932506 - 32ch AIR Open Coil Suite, 1.5T: 2025-05-26 The 32Ch AIR Open Coil Suite is comprised of MRI receive-only phased array RF coils designed for clinically acceptable signal-to
• 00850028932452 - 3T 16ch Breast Coil: 2023-03-31
• 00850028932469 - 1.5T 16ch Breast Coil: 2023-03-31
• 00850028932513 - Biopsy Grid Assembly, Pack, Breast Coil: 2023-03-31
• 00850028932520 - Drape Pack, Biopsy, Breast Coil: 2023-03-31
• 00856181003916 - 1.5T 16ch Shoulder Coil (Device): 2021-01-12 The 16ch Shoulder Coil is a receive-only phased array RF coil designed for optimum signal-to-noise ratio (SNR) and uniform cover
• 00856181003947 - 3.0T 16ch Shoulder Coil (FRU): 2021-01-12 The 16ch Shoulder Coil is a receive-only phased array RF coil designed for optimum signal-to-noise ratio (SNR) and uniform cover