Spine Auto Views

GUDID 00195278534064

Spine Auto Views Medical Device

GE MEDICAL SYSTEMS

CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software

• Primary Device ID: 00195278534064
• NIH Device Record Key: 82d39fb6-bcb0-4f91-ada7-645984da066d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spine Auto Views
• Version Model Number: See CODE part
• Company DUNS: 266062561
• Company Name: GE MEDICAL SYSTEMS
• 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	00195278534064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223424

FDA Product Code

• QIH: Automated Radiological Image Processing Software

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: 2024-03-19
• Device Publish Date: 2024-03-11

Devices Manufactured by GE MEDICAL SYSTEMS

• 00195278719812 - not applicable: 2024-04-19 Software Pristina ME 9.2 - ISO file
• 00195278534064 - Spine Auto Views: 2024-03-19Spine Auto Views Medical Device
• 00195278534064 - Spine Auto Views: 2024-03-19 Spine Auto Views Medical Device
• 00195278795724 - not applicable: 2024-01-30 Software Pristina 8.3 - ISO file
• 00195278719263 - Allia: 2023-12-18 Allia IGS5 UDI
• 00195278719577 - Allia: 2023-12-18 Allia IGS3 UDI
• 00195278719720 - Allia: 2023-12-18 Allia IGS 7 UDI
• 00195278719744 - Allia: 2023-12-18 Allia IGS 7 OR UDI
• 00195278711229 - not applicable: 2023-09-22 UDI Software Pristina