OUTLOOK

System, Nuclear Magnetic Resonance Imaging

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 Outlook.

Pre-market Notification Details

• Device ID: K945827
• 510k Number: K945827
• Device Name: OUTLOOK
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Highland Heights, OH 44143
• Contact: Elaine K Keeler
• Correspondent: Elaine K Keeler; PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Highland Heights, OH 44143
• Product Code: LNH
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-11-29
• Decision Date: 1995-09-18