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510(k) K974522

3D I-SCAN by Ophthalmic Technologies, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1998
Date Received
December 2, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Ophthalmic Technologies, Inc.

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  • K024114 — A-SCAN 100 (January 10, 2003)
  • K990064 — DI-RHEX OPHTHALMIC DIATHERMY SYSTEM (April 4, 1999)
  • K971679 — I-SCOPE OPHTHALMIC ENDOSCOPE (June 25, 1997)
  • K960622 — I-SCAN (May 13, 1996)
  • K954263 — XE-LITE (October 18, 1995)

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