LINUS

System, Imaging, Pulsed Echo, Ultrasonic

FISCHER IMAGING CORP.

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

Pre-market Notification Details

• Device ID: K812398
• 510k Number: K812398
• Device Name: LINUS
• Classification: System, Imaging, Pulsed Echo, Ultrasonic
• Applicant: FISCHER IMAGING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: IYO
• CFR Regulation Number: 892.1560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-08-20
• Decision Date: 1981-11-10