FDA-cleared K203582
QUIBIM Precision Prostate (qp-Prostate)
QUIBIM S.L.
Image analysis/processing for Prostate using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Prostate
- Decision
- 2021-02-04
FDA-cleared profile
SmartTarget
SmartTarget ,QGLFDWLRQVIRU8VH(Describe) The SmartTarget device is intended as an accessory for image-guided interventional and diagnostic procedures involving the prostate gland, and to be used by physicians for enhanced visualization of two-dimensional (2D) transrectal ultrasound TRUS images of the prostate in clin...
Buyer-fit notes
SmartTarget is best reviewed for CT/CTA Prostate teams evaluating prostate imaging 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
SmartTarget ,QGLFDWLRQVIRU8VH(Describe) The SmartTarget device is intended as an accessory for image-guided interventional and diagnostic procedures involving the prostate gland, and to be used by physicians for enhanced visualization of two-dimensional (2D) transrectal ultrasound TRUS images of the prostate in clin...
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