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510(k) K930761

IMAGE-X 70 INTRAORAL X-RAY SYSTEM by Afp Imaging Corp. — Product Code EAP

K930761 is an FDA 510(k) premarket notification submitted by Afp Imaging Corp. for the device "IMAGE-X 70 INTRAORAL X-RAY SYSTEM". The FDA issued a decision of Substantially Equivalent on May 25, 1993. The device falls under product code EAP (Unit, X-Ray, Intraoral), a Class II device regulated under 21 CFR 872.1810. Afp Imaging Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1993
Date Received
February 12, 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 Afp Imaging Corp.

  • K123419 — EVA SELECT DIGITAL DENTAL IMAGING SYSTEM (December 27, 2012)
  • K072357 — NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM (September 18, 2007)
  • K041120 — EV APAN DIGITAL, MODEL K1VSM2000 (August 30, 2004)
  • K030647 — EVA DIGITAL DENTAL X-RAY SYSTEM (March 20, 2003)
  • K014144 — EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 (February 7, 2002)
  • K013176 — MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE (October 16, 2001)
  • K974619 — SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM (February 25, 1998)
  • K950288 — AUTOLASER MULTI FORMAT CAMERA (April 4, 1995)
  • K925885 — AFP 17 X 4 AUTOMATIC FILM PROCESSOR (June 9, 1993)
  • K925684 — OLYMP-X,X-RAY GENERATOR (February 2, 1993)

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