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510(k) K791014

DENTAL XERORADIOGRAPHY by Xerox Medical Systems — Product Code EAP

K791014 is an FDA 510(k) premarket notification submitted by Xerox Medical Systems for the device "DENTAL XERORADIOGRAPHY". The FDA issued a decision of Substantially Equivalent on September 4, 1979. The device falls under product code EAP (Unit, X-Ray, Intraoral), a Class II device regulated under 21 CFR 872.1810. Xerox Medical Systems has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1979
Date Received
June 1, 1979
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 Xerox Medical Systems

  • K853459 — XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM (October 30, 1985)
  • K833243 — MAMMOGRAPHIC S-RAY SYSTEM (October 28, 1983)
  • K832733 — XEROX 120 SYS MAMMOGRAPHIC X-RAY (September 29, 1983)
  • K812024 — XEROX 128 CASSETTE CHANGER (August 13, 1981)

Other clearances for product code EAP

  • K113360 — MEDICAL IMAGE PROCESSING UNIT (February 7, 2012)
  • K102573 — PROVU (TM) DENTAL X-RAY SYSTEM (June 30, 2011)
  • K093453 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (November 30, 2009)
  • K080738 — DENTRON SENSOR (May 13, 2008)
  • K052422 — THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) (September 27, 2005)
  • 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)

FDA data resources