FDA Clears Philips SmartCT Software Version R3.0 (L10) Under 510(k)

U.S. FDA clears Philips Medical Systems' SmartCT R3.0 (L10) software via the 510(k) pathway. The radiology device is classified under product code OWB (computed tomography system/software).

• The clearance was issued under the FDA's 510(k) premarket notification pathway.
• The device is classified under product code OWB (computed tomography system/software).
• Manufacturer: Philips Medical Systems B.V.

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