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510(k) K052904

VIRTUAL MEDICAL SYSTEMS MODEL VT3000 by Scientific Imaging, Inc. — Product Code JXE

K052904 is an FDA 510(k) premarket notification submitted by Scientific Imaging, Inc. for the device "VIRTUAL MEDICAL SYSTEMS MODEL VT3000". The FDA issued a decision of Substantially Equivalent on October 27, 2005. The device falls under product code JXE (Device, Nerve Conduction Velocity Measurement), a Class II device regulated under 21 CFR 882.1550. Scientific Imaging, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2005
Date Received
October 14, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Device, Nerve Conduction Velocity Measurement
Device Class
Class II
Regulation Number
882.1550
Review Panel
NE
Submission Type

Other clearances by Scientific Imaging, Inc.

  • K900773 — NUCLEAR MAX (May 23, 1990)
  • K874750 — VIDEO ANALYZER 4000 (April 25, 1988)

Other clearances for product code JXE

  • K240189 — NM-01/CPT neurometer (NM-01/CPT) (March 26, 2025)
  • K190536 — Mediracer NCS (September 25, 2019)
  • K070109 — NEUROMETRIX ADVANCE (April 25, 2008)
  • K060584 — NC-STAT (July 31, 2006)
  • K053058 — XLTEK NEUROPATH, MODEL PK1070 (February 7, 2006)
  • K041320 — MODIFICATION TO NC-STAT (August 12, 2004)
  • K013459 — MODIFICATION OF NC-STAT (January 17, 2002)
  • K012069 — MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT (August 1, 2001)
  • K003508 — NC-STAT (January 17, 2001)
  • K001692 — NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 (November 24, 2000)

FDA data resources