Nucletron product gets FDA 510(k) clearance

Dutch radiation therapy firm Nucletron has gained U.S. Food and Drug Administration 510(k) clearance for its Spot Pro 3-D ultrasound planning system for all seed-implant techniques. The product covers all planning aspects, including pre-planning, intra-operative live-planning, and post-treatment dosimetry, according to the Veenendaal, Netherlands-based firm.

The unit is available as a stand-alone treatment-planning system for all manual seed implant techniques, and can also be integrated into the vendor’s FIRST (fully integrated real-time seed treatment) system, an automated technique for seed-implant procedures, the company said.

By AuntMinnie.com staff writers
November 20, 2002

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