MyoSPECT ES 5875815-20

GUDID 00195278421579

MyoSPECT ES GANTRY

G E MEDICAL SYSTEMS ISRAEL LTD.

Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system

• Primary Device ID: 00195278421579
• NIH Device Record Key: f459e52b-19f1-4046-9268-e75fe747ebb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyoSPECT ES
• Version Model Number: H3912AB
• Catalog Number: 5875815-20
• Company DUNS: 532102365
• Company Name: G E MEDICAL SYSTEMS ISRAEL LTD.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278421579 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212004

FDA Product Code

• KPS: System, tomography, computed, emission

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: 2021-10-19
• Device Publish Date: 2021-10-11

On-Brand Devices [MyoSPECT ES]

• 00195278421579: MyoSPECT ES GANTRY
• 00195278488626: MyoSPECT ES MDR GANTRY