PREIRUS

GUDID 04961333243105

HITACHI 5.1 SOFTWARE UPGRADE PREIRUS

PENTAX OF AMERICA, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 04961333243105
• NIH Device Record Key: e9d6a430-b7d0-4206-96e1-a115e0ab9bd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREIRUS
• Version Model Number: HITACHI5.1UPGRD
• Company DUNS: 083211284
• Company Name: PENTAX OF AMERICA, 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	04961333243105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093466

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-12

On-Brand Devices [PREIRUS]

• 04961333243143: ULTRASOUND SYSTEM WITH SONO - DEMO
• 04961333243136: HV-PREIRUS SYSTEM WITHOUT ELASTOGTAPHY
• 04961333243129: HV-PREIRUS DEMO ESCORT CASE
• 04961333243112: ADVANCED DIGITAL ULTRASOUND SYSTEM
• 04961333243105: HITACHI 5.1 SOFTWARE UPGRADE PREIRUS
• 04961333240357: ADVANCED DIGITAL ULTRASOUND SYSTEM (USED)