Name: Predicase
Price: 199 USD

K-number	K073081
Device name	JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X
Applicant	Toshiba America Medical Systems, In.C
Product code	LNH
Device class	Class II
Decision date	Nov 21, 2007
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X

Everything you need for a 510(k) submission. Nothing you don't.