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510(k) K971368

IDS4 IMAGE DISPLAY SYSTEM SERIES by O Tech, Inc. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1997
Date Received
April 14, 1997
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 O Tech, Inc.

  • K991643 — IDS4 V3.2 IMAGE DISPLAY SYSTEM (June 8, 1999)
  • K973463 — OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE (December 2, 1997)
  • K971451 — WISE IMAGE MANAGEMENT SYSTEM (June 26, 1997)

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