MyoSPECT ES 5875815-40

GUDID 00195278488626

MyoSPECT ES MDR GANTRY

G E MEDICAL SYSTEMS ISRAEL LTD.

Stationary gamma camera system

• Primary Device ID: 00195278488626
• NIH Device Record Key: 85be9c17-9f84-4726-bef7-fe24ba6e7a33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyoSPECT ES
• Version Model Number: H3912BD
• Catalog Number: 5875815-40
• Company DUNS: 532102365
• Company Name: G E MEDICAL SYSTEMS ISRAEL LTD.
• Device Count: 1
• DM Exempt: true
• 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	00195278488626 [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: 2023-09-22
• Device Publish Date: 2023-09-14

On-Brand Devices [MyoSPECT ES]

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