FACTS

System, X-ray, Tomography, Computed

PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.

The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Facts.

Pre-market Notification Details

• Device ID: K982010
• 510k Number: K982010
• Device Name: FACTS
• Classification: System, X-ray, Tomography, Computed
• Applicant: PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland, OH 44143
• Contact: Robert L Turocy
• Correspondent: Robert L Turocy; PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland, OH 44143
• Product Code: JAK
• Subsequent Product Code: JAA
• Subsequent Product Code: OWB
• CFR Regulation Number: 892.1750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-06-08
• Decision Date: 1998-11-19
• Summary: summary