D630 to D670 DR Upgrade 5953035

GUDID 00195278794772

D630 to D670 DR NM GANTRY UPGRADE KIT

G E MEDICAL SYSTEMS ISRAEL LTD.

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• Primary Device ID: 00195278794772
• NIH Device Record Key: 8eae6ac6-a7b8-45aa-82ed-3eee2973ec5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D630 to D670 DR Upgrade
• Version Model Number: H3101RS
• Catalog Number: 5953035
• 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: 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	00195278794772 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093514

FDA Product Code

• JAK: System, x-ray, tomography, computed

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: 2024-03-26
• Device Publish Date: 2024-03-18

Devices Manufactured by G E MEDICAL SYSTEMS ISRAEL LTD.

• 00195278794772 - D630 to D670 DR Upgrade: 2024-03-26D630 to D670 DR NM GANTRY UPGRADE KIT
• 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: 2023-09-22 MyoSPECT ES to MyoSPECT Upgrade kit
• 00195278592309 - Omni: 2022-09-20 OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY
• 00195278421579 - MyoSPECT ES: 2021-10-19 MyoSPECT ES GANTRY