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510(k) K944684

POLYSCAN DIGITAL SCANNER by Mse Medizintechnik GmbH & Co. KG — Product Code IYW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1995
Date Received
September 22, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scanner, Rectilinear, Nuclear
Device Class
Class I
Regulation Number
892.1300
Review Panel
RA
Submission Type

Other clearances for product code IYW

  • K895799 — RECTILINEAR SCANNER MODEL #187-270 (February 1, 1990)
  • K882453 — POLYSCAN DIGITAL SCANNER (November 23, 1988)
  • K780395 — IMAGER, BODY SECTION, RADIONUCLIDE (March 31, 1978)