Panoramic Corporation

GUDID 00862309000354

System, X-ray, Extraoral Source, Digital Encompass

YOUNG PS ACQUISITION, LLC

Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital

• Primary Device ID: 00862309000354
• NIH Device Record Key: cd3f73fd-5b89-473c-8cfd-805dd9a99cb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Panoramic Corporation
• Version Model Number: Digital Pnaormic X-Ray Encompass
• Company DUNS: 119620784
• Company Name: YOUNG PS ACQUISITION, LLC
• 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	00862309000354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110371

FDA Product Code

• EHD: Unit, X-Ray, Extraoral With Timer

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: 2017-05-24

On-Brand Devices [Panoramic Corporation]

• 00862309000378: X-ray, Tomography, Computed, Dental - Encompass 3D
• 00862309000361: System, X-ray, Extraoral Source, Digital Encompass
• 00862309000354: System, X-ray, Extraoral Source, Digital Encompass
• 00862309000347: Unit, X-ray, Extraoral with Timer- PC-4000
• 00862309000330: Unit, X-ray, Extraoral with Timer- PC-3000
• 00862309000316: Unit, X-ray, Extraoral with timer-PC-1000/Laser 1000
• 00862309000309: PC-1000