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510(k) K980970

IIRAD DIRECTRAY OPERATOR CONSOLE by Sterling Diagnostic Imaging, Inc. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1998
Date Received
March 16, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by Sterling Diagnostic Imaging, Inc.

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  • K973206 — STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY (December 4, 1997)
  • K972660 — RAVEN DRY PRINTER (November 10, 1997)
  • K973028 — HELIOS LASER IMAGER 1417 (October 28, 1997)
  • K964250 — LINX NETWORKING SYSTEM (December 18, 1996)

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