Simplicit90Y

GUDID B334SY2P00

MIRADA MEDICAL LIMITED

Radiology picture archiving and communication system workstation

• Primary Device ID: B334SY2P00
• NIH Device Record Key: cf0c9a9a-3c59-4953-b08d-792e86e9798b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simplicit90Y
• Version Model Number: 2.0
• Company DUNS: 211100325
• Company Name: MIRADA MEDICAL LIMITED
• 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: 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
HIBCC	B334SY2P00 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182016

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2019-03-11
• Device Publish Date: 2019-02-15

On-Brand Devices [Simplicit90Y]

• B334SY2P00: 2.0
• B334SY2P20: 2.2
• B334SY2P40: 2.4
• B334SY2P60: 2.6
• B334SY2P10: 2.10
• B334SY2P120: 2.12