ORCA

Image-intensified Fluoroscopic X-ray System, Mobile

LUNAR CORP.

The following data is part of a premarket notification filed by Lunar Corp. with the FDA for Orca.

Pre-market Notification Details

• Device ID: K960907
• 510k Number: K960907
• Device Name: ORCA
• Classification: Image-intensified Fluoroscopic X-ray System, Mobile
• Applicant: LUNAR CORP. 313 WEST BELTLINE HIGHWAY Madison, WI 53713
• Contact: Gary Syring
• Correspondent: Gary Syring; LUNAR CORP. 313 WEST BELTLINE HIGHWAY Madison, WI 53713
• Product Code: OXO
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-03-05
• Decision Date: 1996-05-20
• Summary: summary