SubtlePET

GUDID 00860000171205

SubtlePET is an image processing software intended for use by radiologists and nuclear medicine physicians for transfer, storage, and noise reduction of fluorodeoxyglucose (FDG), amyloid, 18F-DOPA, 18F-DCFPyL, Ga-68 Dotatate, and Ga-68 PSMA radiotracer PET images (including PET/CT and PET/MRI).

Subtle Medical, Inc.

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• Primary Device ID: 00860000171205
• NIH Device Record Key: 573eb462-0a45-428d-bbc1-f09affbb170a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SubtlePET
• Version Model Number: 2.x
• Company DUNS: 081069974
• Company Name: Subtle Medical, Inc.
• 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	00860000171205 [Primary]

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2022-05-09
• Device Publish Date: 2022-04-29

Devices Manufactured by Subtle Medical, Inc.

• 00860000171205 - SubtlePET: 2022-05-09SubtlePET is an image processing software intended for use by radiologists and nuclear medicine physicians for transfer, storage, and noise reduction of fluorodeoxyglucose (FDG), amyloid, 18F-DOPA, 18F-DCFPyL, Ga-68 Dotatate, and Ga-68 PSMA radiotracer PET images (including PET/CT and PET/MRI).
• 00860000171205 - SubtlePET: 2022-05-09 SubtlePET is an image processing software intended for use by radiologists and nuclear medicine physicians for transfer, storage
• 00860000171212 - SubtleMR: 2022-05-09 SubtleMR is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image no