Medical Device Manufacturer · FI , Tuusula

Palodex Group OY - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2012

Recent clearances: Orthopantomograph™ OP 3D LX (PAN 3D), Orthopantomograph™ OP 3D LX, Orthopantomograph OP 3D

10
Total
10
Cleared
0
Denied

FDA 510(k) Regulatory Record - Palodex Group OY Radiology ✕

10 devices
1-10 of 10
Cleared Sep 12, 2024
Orthopantomograph™ OP 3D LX (PAN 3D)
K241249 · OAS
Radiology · 132d
Cleared Jun 09, 2023
Orthopantomograph™ OP 3D LX
K230505 · OAS
Radiology · 105d
Cleared Jun 07, 2018
Orthopantomograph OP 3D
K180947 · OAS
Radiology · 57d
Cleared Dec 19, 2017
FS Ergo
K173646 · MUH
Radiology · 22d
Cleared Aug 31, 2017
Orthopantomograph OP300
K163423 · OAS
Radiology · 268d
Cleared Apr 25, 2017
Cliniview
K162799 · LLZ
Radiology · 202d
Cleared Apr 07, 2017
ORTHOPANTOMOGRAPH OP 3D
K170813 · OAS
Radiology · 21d
Cleared Mar 26, 2014
OP300
K133544 · OAS
Radiology · 128d
Cleared May 29, 2013
SCANORA 3DX
K130297 · OAS
Radiology · 112d
Cleared Dec 10, 2012
OP300
K122018 · OAS
Radiology · 153d
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