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FDA 510(k) Application Details - K070542
Device Classification Name
System, Tomography, Computed, Emission
More FDA Info for this Device
510(K) Number
K070542
Device Name
System, Tomography, Computed, Emission
Applicant
DIGIRAD CORP.
13950 STOWE DRIVE
POWAY, CA 92064-8803 US
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Contact
Joel Tuckey
Other 510(k) Applications for this Contact
Regulation Number
892.1200
More FDA Info for this Regulation Number
Classification Product Code
KPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/26/2007
Decision Date
03/23/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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