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510(k) K894935

S-70 PORTABLE DENTAL X-RAY SYSTEM by Lorad Medical Systems, Inc. — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1990
Date Received
August 3, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Extraoral With Timer
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

Other clearances by Lorad Medical Systems, Inc.

  • K921962 — LORAD DIGITAL SPOT MAMMOGRAPHY (November 23, 1992)
  • K922619 — DIGITIZER, MODEL # 3-000A-1518 (July 1, 1992)
  • K913732 — MAMMOGRAPHIC X-RAY SYSTEM (February 3, 1992)
  • K913478 — RADIOGRAPHIC FILM MARKING SYSTEM (October 15, 1991)
  • K894643 — RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT (December 14, 1989)
  • K882875 — STEREOTACTIC BREAST LESION LOCALIZATION ACCESSORY (November 7, 1988)
  • K842102 — LORAD (July 17, 1984)

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