510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991455Substantially Equivalent

Orthoslice Os1000 Series; Panoramic Orthoslice Os 1000: Os1000, Os1000e Panoramic and Cephalometric Orthoslice Os1000c,

Trophy Radiologie, Marne La Vallee Cedex 2, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991455 is the FDA 510(k) clearance record for ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C,, a class II device, cleared for Trophy Radiologie on under FDA product code EHD (Unit, X-Ray, Extraoral With Timer). FDA records list 16 510(k) clearances for Trophy Radiologie, from to . As of , FDA records show no recalls naming K991455.

Clearance record

Decision date
Received
(60 days to decision)
Product code
EHD Unit, X-Ray, Extraoral With Timer
Regulation
21 CFR 872.1800
Device class
Class II
Review panel
Dental
Applicant
Trophy Radiologie 4 Rue F. Pelloutier, Marne La Vallee Cedex 2, FR
510(k) summary
Statement
Third party review
No

Clearances, product code EHD

Trailing 12 months
6 clearances under product code EHD in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EHD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20262
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260