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510(k) K955643

ALARA IMAGING SYSTEM by Denoptix, Inc. — Product Code EGY

K955643 is an FDA 510(k) premarket notification submitted by Denoptix, Inc. for the device "ALARA IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on March 1, 1996. The device falls under product code EGY (Processor, Radiographic-Film, Automatic, Dental), a Class II device regulated under 21 CFR 892.1900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1996
Date Received
December 12, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Processor, Radiographic-Film, Automatic, Dental
Device Class
Class II
Regulation Number
892.1900
Review Panel
RA
Submission Type

Other clearances for product code EGY

  • K992896 — DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830) (September 3, 1999)
  • K955825 — SMITH S-100 TIME & TEMPERATURE CONTROL (April 5, 1996)
  • K945682 — PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL (February 9, 1995)
  • K900156 — AP201 DENTAL X-RAY FILM PROCESSOR (May 14, 1990)
  • K874118 — MODEL 410 DENTAL X-RAY FILM PROCESSORS (November 6, 1987)
  • K811211 — YOSHIDA AP 100 (June 16, 1981)
  • K771433 — AUTO. DEVEL. UNIT FOO DENTAL X-RAY (August 19, 1977)
  • K770783 — FILM PROCESSOR, AUTOMATIC (May 10, 1977)

FDA data resources