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510(k) K931486

INTREX VSK INTERORAL DENTAL X-RAY UNIT by Keystone X-Ray, Inc. — Product Code EAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1993
Date Received
March 24, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Intraoral
Device Class
Class II
Regulation Number
872.1810
Review Panel
RA
Submission Type

Other clearances by Keystone X-Ray, Inc.

  • K930925 — INTREX INTERORAL DENTAL X-RAY UNIT (July 13, 1993)
  • K883354 — VARIABLE KV INTREX VSK 60 - 90 KVP (December 21, 1988)
  • K812217 — FLUORO AUTOMATIC BRIGHTNESS SYS (September 16, 1981)

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  • K041385 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (June 7, 2004)
  • K960819 — HELIODENT DS (March 29, 1996)
  • K960028 — ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM (March 1, 1996)
  • K953936 — ATLANTIS (December 28, 1995)
  • K954565 — EXPLOR-X (AZTEH) HF (October 27, 1995)