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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K111024
Device Name JETPACK 2.0
Applicant
Philips Medical Systems (Cleveland), Inc.
3860 N. 1st St.
San Jose,  CA  95134
Applicant Contact LORI R PETERSON
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/12/2011
Decision Date 04/21/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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