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510(k) K872132

SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS by Sopha Medical Systems, Inc. — Product Code IXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1987
Date Received
June 3, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Radiographic Cassette, Wall-Mounted
Device Class
Class I
Regulation Number
892.1880
Review Panel
RA
Submission Type

Other clearances by Sopha Medical Systems, Inc.

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  • K942837 — DST-XL (January 5, 1995)
  • K921008 — VECTOR SERIES (April 27, 1992)
  • K913641 — SOPHY NXT (December 17, 1991)
  • K911346 — SOPHYCAMERA DSX BODYTRAK (April 18, 1991)
  • K894931 — SOPHYCAMERA DSX RECTANGULAR (October 27, 1989)
  • K872297 — DS-7 NUCLEAR MEDICINE GAMMA CAMERA (August 12, 1987)

Other clearances for product code IXY

  • K953336 — VRS 3 WALL STAND (August 11, 1995)
  • K953402 — UNIVERSIX 190 (August 11, 1995)
  • K946114 — SENSORI-MOTOR RATING SCALE (April 28, 1995)
  • K946260 — NTBS-1417, 1436, TBS-1417 (March 31, 1995)
  • K930230 — RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER (April 27, 1993)
  • K930249 — BC/WT/PF (April 27, 1993)
  • K925934 — WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT (March 4, 1993)
  • K924445 — BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY (February 19, 1993)
  • K922443 — VERT-X UNIVERSAL VERTICAL BUCKY STAND (October 26, 1992)
  • K915667 — MODEL H170 PEDIATRIC CHEST X-RAY UNIT (January 31, 1992)