510(k) Premarket Notification

• Device Classification Name: system, imaging, pulsed echo, ultrasonic
• 510(K) Number: K121479
• Device Name: AIM
• Applicant: INNEROPTIC TECHNOLOGY, INC; 106-a n churton st; hillsborough, NC 27278
• Contact: caroline green
• Regulation Number: 892.1560
• Classification Product Code: IYO
• Subsequent Product Code: OEW
• Date Received: 05/18/2012
• Decision Date: 09/13/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Radiology
• Review Advisory Committee: Radiology
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No