IMAGER

System, X-ray, Angiographic

FISCHER IMAGING CORP.

The following data is part of a premarket notification filed by Fischer Imaging Corp. with the FDA for Imager.

Pre-market Notification Details

• Device ID: K883831
• 510k Number: K883831
• Device Name: IMAGER
• Classification: System, X-ray, Angiographic
• Applicant: FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120
• Contact: Richard S Lucas
• Correspondent: Richard S Lucas; FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120
• Product Code: IZI
• CFR Regulation Number: 892.1600 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-09-09
• Decision Date: 1988-11-21