CAAS

System, Image Processing, Radiological

PIE MEDICAL IMAGING B.V.

The following data is part of a premarket notification filed by Pie Medical Imaging B.v. with the FDA for Caas.

Pre-market Notification Details

• Device ID: K052988
• 510k Number: K052988
• Device Name: CAAS
• Classification: System, Image Processing, Radiological
• Applicant: PIE MEDICAL IMAGING B.V. BECANUSSTRAAT 13 D Maastricht, NL 6216 Bx
• Contact: Carla De Vries
• Correspondent: Carla De Vries; PIE MEDICAL IMAGING B.V. BECANUSSTRAAT 13 D Maastricht, NL 6216 Bx
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-10-24
• Decision Date: 2005-12-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08056304451132	K052988	000