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510(k) K031148

IN-VISION IMAGING SYSTEM by Jomed, Inc. — Product Code DXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2003
Date Received
April 10, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Echocardiograph
Device Class
Class II
Regulation Number
870.2330
Review Panel
CV
Submission Type

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  • K021219 — SMARTWIRE/SMARTMAP PRESSURE SYSTEM (May 17, 2002)
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  • K010838 — FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003, A1400 (June 21, 2001)
  • K003938 — TRAK BACK II (January 18, 2001)

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  • K904975 — VISTA VIEWING STATION (February 25, 1991)
  • K904978 — SOFTWARE PROGRAM USED W/PRISM PRODUCTS (February 25, 1991)
  • K904976 — CINE'VIEW - STRESS ECHO & IMAGE REVIEW (February 25, 1991)
  • K904977 — CINE/VIEW PLUS - CARDIOLOGY WORKSTATION (February 25, 1991)