PCI gets FDA clearance for Automated Reprocessor for TEE Ultrasound Probes

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PCI medical has been granted FDA 510(k) clearance for the TD-100 an automated disinfector for transesophageal (TEE) probes. Previously TEE probes could only be manually disinfected and rinsed. Manual reprocessing of these delicate probes is difficult and time consuming, and can cause costly damage. 

The TD-100 is similar in function to the widely used endoscopic reprocessors found in most CS and endoscopy departments. It automatically completes the disinfection and rinse cycles in less than 18 minutes, PCI said.

A printed validation is generated at the end of the completed cycle, giving a permanent record of quality assurance.