FDA-cleared K251370
Cartesion Prime (PCD-1000A/3) V10.21
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2025-12-01
Buyer-fit notes
TruSPECT Processing Station is best reviewed for PET/SPECT/Nuclear Medicine teams evaluating nuclear medicine tools with FDA source traceability.
Not ideal for buyers who need public price benchmarks before vendor contact or teams requiring confirmed deployment details before shortlist review.
FDA and evidence source ledger
Clinical use
Image analysis/processing.
Alternatives
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Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2025-07-17
FDA-cleared K251153
Aurora
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Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2025-06-12
FDA-cleared K243614
Sonio Suspect
Sonio
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2025-02-21