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510(k) K011290

PROGNOST ES, MODEL 0302 0000 by Xmar Corp. — Product Code IZF

K011290 is an FDA 510(k) premarket notification submitted by Xmar Corp. for the device "PROGNOST ES, MODEL 0302 0000". The FDA issued a decision of Substantially Equivalent on May 30, 2001. The device falls under product code IZF (System, X-Ray, Tomographic), a Class II device regulated under 21 CFR 892.1740.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2001
Date Received
April 27, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomographic
Device Class
Class II
Regulation Number
892.1740
Review Panel
RA
Submission Type

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FDA data resources