OLEA SPHERE

System, Image Processing, Radiological

OLEA MEDICAL

The following data is part of a premarket notification filed by Olea Medical with the FDA for Olea Sphere.

Pre-market Notification Details

• Device ID: K120196
• 510k Number: K120196
• Device Name: OLEA SPHERE
• Classification: System, Image Processing, Radiological
• Applicant: OLEA MEDICAL 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701
• Contact: Kristi Gusman
• Correspondent: Kristi Gusman; OLEA MEDICAL 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-01-23
• Decision Date: 2012-04-19
• Summary: summary