510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955643Substantially Equivalent

Alara Imaging System

Denoptix, Inc., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955643 is the FDA 510(k) clearance record for ALARA IMAGING SYSTEM, a class II device, cleared for Denoptix, Inc. on under FDA product code EGY (Processor, Radiographic-Film, Automatic, Dental). FDA records list one 510(k) clearance for Denoptix, Inc. As of , FDA records show no recalls naming K955643.

Clearance record

Decision date
Received
(80 days to decision)
Product code
EGY Processor, Radiographic-Film, Automatic, Dental
Regulation
21 CFR 892.1900
Device class
Class II
Review panel
Radiology
Applicant
Denoptix, Inc. 270 Santa Ana Ct., Sunnyvale CA
510(k) summary
Summary
Third party review
No

Clearances, product code EGY

Trailing 12 months

FDA records hold no clearances under product code EGY in the trailing twelve months.

FDA records show no clearances under product code EGY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EGY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260