CAAS Workstation

System, X-ray, Angiographic

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 Workstation.

Pre-market Notification Details

• Device ID: K151780
• 510k Number: K151780
• Device Name: CAAS Workstation
• Classification: System, X-ray, Angiographic
• Applicant: PIE MEDICAL IMAGING B.V. PHILIPSWEG 1 Maastricht, NL 6227 Aj
• Contact: Florie Daniels
• Correspondent: Florie Daniels; PIE MEDICAL IMAGING B.V. PHILIPSWEG 1 Maastricht, NL 6227 Aj
• Product Code: IZI
• CFR Regulation Number: 892.1600 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-07-01
• Decision Date: 2016-03-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08056304451200	K151780	000
08056304453761	K151780	000
08056304453440	K151780	000
08056304453099	K151780	000