510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K895467Substantially Equivalent

Orthophos and Orthophos C

Siemens Medical Solutions USA, Inc., Iselin NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895467 is the FDA 510(k) clearance record for ORTHOPHOS AND ORTHOPHOS C, a class II device, cleared for Siemens Medical Solutions USA, Inc. on under FDA product code EHD (Unit, X-Ray, Extraoral With Timer). FDA records list 829 510(k) clearances for Siemens Medical Solutions USA, Inc., from to . As of , FDA records show no recalls naming K895467.

Clearance record

Decision date
Received
(67 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
Siemens Medical Solutions USA, Inc. 186 Wood Ave. S., Iselin NJ
Third party review
No

Clearances, product code EHD

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