ImageDrive Pro SYN-0627

GUDID 00670082000122

Synaptive Medical Inc

Radiology PACS software Radiology PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software

• Primary Device ID: 00670082000122
• NIH Device Record Key: b9cf7704-3a4d-4e58-9f60-e0ab8e25612b
• Commercial Distribution Discontinuation: 2017-08-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ImageDrive Pro
• Version Model Number: 1.1
• Catalog Number: SYN-0627
• Company DUNS: 203061833
• Company Name: Synaptive Medical 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	00670082000122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153284

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-05-23
• Device Publish Date: 2017-08-16

Devices Manufactured by Synaptive Medical Inc

• 00670082000603 - Modus IR: 2024-04-10 Surgical Exoscope Fluorescence Filter
• 10670082000495 - Evry: 2023-10-24
• 00670082000511 - Modus Plan: 2023-10-18
• 00670082000566 - Modus X: 2023-03-14 Robotic Exoscope
• 00670082000573 - Modus X: 2023-03-14 Robotic Exoscope
• 00670082000580 - Modus Blue: 2023-03-14 Robotic Exoscope Fluorescence Filter
• 00670082000085 - BrightMatter Plan: 2019-08-16
• 00670082000160 - BrightMatter Plan: 2019-08-16