dS TorsoCardiac 1.5T

GUDID 00884838096813

The Device is designed to be used in conjunction with MR Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.

Philips Healthcare (Suzhou) Co., Ltd.

MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency

• Primary Device ID: 00884838096813
• NIH Device Record Key: a6f85889-3cfe-4066-8e86-a9b071b897c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: dS TorsoCardiac 1.5T
• Version Model Number: 45980168199X
• Company DUNS: 421265537
• Company Name: Philips Healthcare (Suzhou) Co., 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838096813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212864

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

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: 2022-04-25
• Device Publish Date: 2022-04-17

Devices Manufactured by Philips Healthcare (Suzhou) Co., Ltd.

• 00884838096813 - dS TorsoCardiac 1.5T: 2022-04-25The Device is designed to be used in conjunction with MR Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
• 00884838096813 - dS TorsoCardiac 1.5T: 2022-04-25 The Device is designed to be used in conjunction with MR Scanner to produce diagnostic images of the anatomy of interest that ca
• 00884838096820 - dS MSK S 1.5T: 2022-04-25 The Device is designed to be used in conjunction with MR Scanner to produce diagnostic images of the anatomy of interest that ca
• 00884838096837 - dS MSK M 1.5T: 2022-04-25 The Device is designed to be used in conjunction with MR Scanner to produce diagnostic images of the anatomy of interest that ca
• 00884838105508 - Incisive CT: 2022-01-07 The Incisive CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconst
• 00884838095199 - DigitalDiagnost C50: 2020-09-14 Stationary x-ray system
• 00884838095205 - DuraDiagnost: 2020-09-14 Stationary x-ray system
• 00884838085015 - Incisive CT: 2019-10-09
• 00884838082366 - DigitalDiagnost C50: 2018-07-06 The DigitalDiagnost C50 is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or te