!M1

GUDID 07350011170012

Mobile x-ray device

Solutions For Tomorrow AB

Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital

• Primary Device ID: 07350011170012
• NIH Device Record Key: 5110b842-cfb7-4a6f-ad36-9dd57c861356
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: !M1
• Version Model Number: A
• Company DUNS: 350420678
• Company Name: Solutions For Tomorrow AB
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350011170012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170607

FDA Product Code

• IZL: System, X-Ray, Mobile

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: 2022-11-10
• Device Publish Date: 2022-11-02

Devices Manufactured by Solutions For Tomorrow AB

• 07350011170111 - ! Mobile wallstand: 2023-03-17 Mobile wallstand for radiographic imaging
• 07350011170012 - !M1: 2022-11-10Mobile x-ray device
• 07350011170012 - !M1: 2022-11-10 Mobile x-ray device