MyoSEPCT ES to MyoSPECT Upgrade 5941445

GUDID 00195278722546

MyoSPECT ES to MyoSPECT Upgrade kit

G E MEDICAL SYSTEMS ISRAEL LTD.

Stationary gamma camera system

• Primary Device ID: 00195278722546
• NIH Device Record Key: 70bbdb9f-d2fe-4739-afc9-056316168c76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyoSEPCT ES to MyoSPECT Upgrade
• Version Model Number: H3912BS
• Catalog Number: 5941445
• 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: 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	00195278722546 [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

Devices Manufactured by G E MEDICAL SYSTEMS ISRAEL LTD.

• 00195278870490 - StarGuide MDD to MDR Upgrade: 2024-05-24 StarGuide SW and Labels Upgrade
• 00195278755544 - StarGuide: 2024-04-26 StarGuide NM GANTRY MDR FINAL
• 00195278794772 - D630 to D670 DR Upgrade: 2024-03-26 D630 to D670 DR NM GANTRY UPGRADE KIT
• 00195278788252 - NM: 2023-11-23 830 NM GANTRY FINAL WITH NEW ROTOR - MDR CE
• 00195278788269 - NMCT: 2023-11-22 870 DR NM GANTRY FINAL WITH NEW ROTOR - MDR CE
• 00195278488619 - MyoSPECT: 2023-09-22 MyoSPECT MDR GANTRY
• 00195278488626 - MyoSPECT ES: 2023-09-22 MyoSPECT ES MDR GANTRY
• 00195278722546 - MyoSEPCT ES to MyoSPECT Upgrade: 2023-09-22MyoSPECT ES to MyoSPECT Upgrade kit
• 00195278722546 - MyoSEPCT ES to MyoSPECT Upgrade: 2023-09-22 MyoSPECT ES to MyoSPECT Upgrade kit