CLEAREAD DETECT

FDA Premarket Approval P000041 S011

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval to market the device under the additional trade name clearread detect.

• Device: CLEAREAD DETECT
• Generic Name: Analyzer, Medical Image
• Applicant: RIVERAIN MEDICAL GROUP
• Date Received: 2012-02-14
• Decision Date: 2012-02-27
• PMA: P000041
• Supplement: S011
• Product Code: MYN
• Advisory Committee: Radiology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: RIVERAIN MEDICAL GROUP 3020 South Tech Blvd. miamisburg, OH 45342-4860

Supplemental Filings

Supplement Number	Date	Supplement Type
P000041		Original Filing
S011	2012-02-14	Normal 180 Day Track No User Fee
S010	2011-09-02	Normal 180 Day Track
S009	2009-12-10	Normal 180 Day Track
S008
S007
S006	2007-07-26	Normal 180 Day Track No User Fee
S005	2006-07-05	Normal 180 Day Track
S004
S003	2005-11-18	Normal 180 Day Track No User Fee
S002	2003-07-10	Normal 180 Day Track No User Fee
S001	2003-02-13	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
M722XD25114C250640	P000041	000
M722XC25114C250640	P000041	000
M722X25122C250640	P000041	000