RayCare

GUDID 07350002010280

Raysearch Laboratories AB (Publ)

Radiology information system application software

• Primary Device ID: 07350002010280
• NIH Device Record Key: c15f70f5-c55e-4695-be54-a3ba3bc3b336
• Commercial Distribution Discontinuation: 2022-05-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: RayCare
• Version Model Number: 3.1
• Company DUNS: 355977901
• Company Name: Raysearch Laboratories AB (Publ)
• 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: false
• 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	07350002010280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200487

FDA Product Code

• MUJ: System, Planning, Radiation Therapy Treatment

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-01
• Device Publish Date: 2020-08-24

On-Brand Devices [RayCare]

• 07350002010259: 3.0.1
• 07350002010181: 3.0
• 07350002010341: 4.0
• 07350002010198: 2.3
• 07350002010419: 4.1.1
• 07350002010396: 5.0
• 07350002010358: 4.1
• 07350002010532: 5B SP1
• 07350002010280: 3.1
• 07350002010464: 5A SP1