Name: Predicase
Price: 199 USD

K-number	K971054
Device name	OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS
Applicant	Siemens Medical Solutions USA, Inc.
Product code	JAK
Device class	Class II
Decision date	Jun 13, 1997
Decision	Substantially Equivalent
Regulation	892.1750

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Source

View the full FDA submission: accessdata.fda.gov

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OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS

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