Home / 510(k) Clearances / K013176

510(k) K013176

MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE by Afp Imaging Corp. — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2001
Date Received
September 24, 2001
Clearance Type
Special
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 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)
  • 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)
  • K930761 — IMAGE-X 70 INTRAORAL X-RAY SYSTEM (May 25, 1993)
  • K925684 — OLYMP-X,X-RAY GENERATOR (February 2, 1993)

Other clearances for product code EHD

  • K252110 — Dental X-RAY Unit (AJX200) (March 12, 2026)
  • K254018 — Portable Dental X-ray Device (GT-1) (February 19, 2026)
  • K252909 — Diagnostic X-Ray Equipment Model POCT22 (February 3, 2026)
  • K251438 — Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) (September 4, 2025)
  • K242185 — Rextar Pro (December 4, 2024)
  • K242591 — XERO-alpha (November 1, 2024)
  • K241963 — WERAY (July 30, 2024)
  • K241305 — LifeRay Intraoral Handheld X-ray System (July 5, 2024)
  • K240759 — REMEX-GR100 (May 13, 2024)
  • K233914 — XVbeam2000 (February 8, 2024)