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510(k) K934645

RADWORKS by Radworks Corp. — Product Code EAP

K934645 is an FDA 510(k) premarket notification submitted by Radworks Corp. for the device "RADWORKS". The FDA issued a decision of Substantially Equivalent on August 17, 1994. The device falls under product code EAP (Unit, X-Ray, Intraoral), a Class II device regulated under 21 CFR 872.1810.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1994
Date Received
September 21, 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 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