INTUITION

System, Image Processing, Radiological

TERARECON, INC.

The following data is part of a premarket notification filed by Terarecon, Inc. with the FDA for Intuition.

Pre-market Notification Details

• Device ID: K121916
• 510k Number: K121916
• Device Name: INTUITION
• Classification: System, Image Processing, Radiological
• Applicant: TERARECON, INC. 4000 E 3rd Ave Ste 200 Foster City, CA 94404
• Contact: Robert Taylor
• Correspondent: Robert Taylor; TERARECON, INC. 4000 E 3rd Ave Ste 200 Foster City, CA 94404
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-07-02
• Decision Date: 2013-04-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
INTUITION6	K121916	000
INTUITION5	K121916	000
INTUITION4	K121916	000
INTUITION11	K121916	000
INTUITION10	K121916	000
INTUITION04	K121916	000