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510(k) K973028

HELIOS LASER IMAGER 1417 by Sterling Diagnostic Imaging, Inc. — Product Code LMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1997
Date Received
August 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Multi Format, Radiological
Device Class
Class II
Regulation Number
892.2040
Review Panel
RA
Submission Type

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  • K973206 — STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY (December 4, 1997)
  • K972660 — RAVEN DRY PRINTER (November 10, 1997)
  • K964250 — LINX NETWORKING SYSTEM (December 18, 1996)

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