FDA-cleared profile

BladderScan Prime PLUS System

BladderScan PRIME PLUS system Transducer: N/A Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: N = new indication; P = previously cleared by FDA; E = added under this appendix * Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, H...

Buyer-fit notes

BladderScan Prime PLUS System is best reviewed for Ultrasound teams evaluating ultrasound workflow 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

BladderScan PRIME PLUS system Transducer: N/A Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: N = new indication; P = previously cleared by FDA; E = added under this appendix * Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, H...

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Modality
Ultrasound
Anatomy
N/A
Decision
2025-12-22