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510(k) K001894

MODIFICATION TO E-SCAN by Biosound Esaote, Inc. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2000
Date Received
June 21, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

Other clearances by Biosound Esaote, Inc.

  • K023255 — TECHNOS MP, MODEL AU6 (February 11, 2003)
  • K014168 — AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE (April 25, 2002)
  • K020164 — E-SCAN XQ (February 12, 2002)
  • K012728 — E-SCAN MRI SYSTEM (August 29, 2001)
  • K010405 — 7230 ULTRASOUND IMAGING SYSTEM WITH TEI (March 13, 2001)
  • K010057 — MODIFICATION TO ARTOSCAN M (February 2, 2001)
  • K000931 — AU5 ULTRASOUND IMAGING SYSTEM (June 8, 2000)
  • K000681 — AU5, AU6 (May 3, 2000)
  • K994369 — 7250 (MEGAS) (February 24, 2000)
  • K990968 — E-SCAN (May 27, 1999)

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  • K252379 — AIR Recon DL (December 23, 2025)
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