BETA
Point-of-care MRI systems for MRI-guided prostate procedures, with AI and robotic capabilities in development.
Promaxo develops low-field MRI technology for prostate procedures in urology practices, ambulatory surgery centers and hospitals. Its Oakland, California-based team combines imaging hardware, software and procedural workflow tools. The platform is intended to bring MRI guidance to the location where patients receive care.
The commercial MRI system must be distinguished from the broader development platform. The company states that its MRI images are not intended for diagnostic purposes and that AI-powered screening and targeting and robotic needle guidance are not yet cleared for commercial use. The profile therefore does not treat every capability described on the website as an authorized indication.
Its commercial audience includes urologists, practice owners and facility administrators evaluating procedural equipment, training, installation and economics. Company-hosted clinical publications and physician accounts provide evidence leads, but promotional comparisons and reimbursement projections require separate assessment.
Promaxo’s MRI system has matched 510(k) decisions for its labeled clinical scope. The company distinguishes its marketed MRI-guided prostate-biopsy system from AI screening/targeting and robotic needle-guidance capabilities that are not yet cleared for commercial use. [12][9][10][2][3][14][13][1]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [7][5]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Office-based MRI platform used for MRI-guided prostate procedures; images are not intended for diagnostic use. [12][9][10]
FDA-clearedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Commercial MRI deployment is distinct from AI and robotic guidance development. No launch date or authorization for those development features is assumed. [12][14]
AI tissue characterization and robotic needle guidance described by the company as not cleared for commercial use. [12]
Investigational / in developmentInvestigational only; not commercially available.
FDA recorded a further decision for MRI System II; this does not clear all AI or robotics capabilities. [10]
FDA recorded a substantially equivalent decision for the Promaxo MRI System. [9]
Accessed 10/29/2026