Turn this list into an evaluation

Each entry is an FDA submission, not a distinct commercial offer. Inspect the exact record before comparing evidence, asking for a quote or planning an integration.

Prepare with a buyer guide:

Clinical guide links appear when this list contains a current reviewed example. They do not classify or endorse the other entries. All buyer guides · Compare exact records · Documented families

FDA-cleared K252563

Neurophet SCALE PET

Neurophet., Inc.

Authorized purpose: Brain MRI/PET registration, segmentation and quantitative PET assessment

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Brain
Decision
2026-05-15
FDA-cleared K261273

Neurophet AQUA

Neurophet., Inc.

Authorized purpose: Neurophet AQUA is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures and lesions from a set of MR images; volumetric data may be compared to reference percentile data.

Modality
MRI
Anatomy
Brain; segmentable structures and lesions
Decision
2026-05-15
FDA-cleared K252496

Neurophet AQUA AD Plus

Neurophet., Inc.

Authorized purpose: Quantitative brain MRI and amyloid-PET analysis, including volumetric reference-percentile comparison and SUVR quantification, to support physician clinical evaluation.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Brain
Decision
2026-01-29
FDA-cleared K242215

Neurophet AQUA (V3.1)

Neurophet, Inc.

Authorized purpose: Neurophet AQUA is intended for Automatic labeling, visualization and volumetric quantification of segmentable brain structures and lesions from a set of MR images. Volumetric data may be compared to reference percentile data.

Modality
MRI
Anatomy
Brain
Decision
2024-10-25
FDA-cleared K220437

Neurophet AQUA

NEUROPHET, Inc.

Authorized purpose: Automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images, with optional comparison of volumetric data to reference percentile data; a support tool for structural-MRI assessment.

Modality
MRI
Anatomy
Segmentable brain structures.
Decision
2023-05-10