BIOJET

System, Image Processing, Radiological

JET SOFT SRL

The following data is part of a premarket notification filed by Jet Soft Srl with the FDA for Biojet.

Pre-market Notification Details

• Device ID: K122329
• 510k Number: K122329
• Device Name: BIOJET
• Classification: System, Image Processing, Radiological
• Applicant: JET SOFT SRL STR. ANASTTASIE PANU NR. 6 Bucharest, RO 031164
• Contact: Peter-m Klews
• Correspondent: Olaf Teichert; TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2012-08-01
• Decision Date: 2012-08-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04260476810015	K122329	000