SubtleMR

GUDID 00860000171212

SubtleMR is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image noise for head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal regions of the body, or increase image sharpness for head MRI.

Subtle Medical, Inc.

Radiology DICOM image processing application software

• Primary Device ID: 00860000171212
• NIH Device Record Key: 7114a7cc-e896-4784-9222-80a2cd339c06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SubtleMR
• 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	00860000171212 [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: 2022-05-09 SubtlePET is an image processing software intended for use by radiologists and nuclear medicine physicians for transfer, storage
• 00860000171212 - SubtleMR: 2022-05-09SubtleMR is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image noise for head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal regions of the body, or increase image sharpness for head MRI.
• 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