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510(k) K882453

POLYSCAN DIGITAL SCANNER by Medical and Scientific Enterprises, Inc. — Product Code IYW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1988
Date Received
June 14, 1988
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 by Medical and Scientific Enterprises, Inc.

  • K933131 — BISTAT 70/70-I ELECTROSURGICAL UNIT (February 15, 1994)
  • K913881 — ENDOSTAT ELECTROSURGICAL UNIT (November 1, 1991)
  • K895855 — PHOENIX (January 22, 1990)
  • K861233 — DUAL PHOTON BONE DENSITOMETER (March 3, 1987)

Other clearances for product code IYW

  • K944684 — POLYSCAN DIGITAL SCANNER (May 15, 1995)
  • K895799 — RECTILINEAR SCANNER MODEL #187-270 (February 1, 1990)
  • K780395 — IMAGER, BODY SECTION, RADIONUCLIDE (March 31, 1978)