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

Image-Intensified Fluoroscopic X-Ray System, Mobile

21 CFR 892.1650 / Radiology
FDA source (opens on fda.gov)

OXO is the FDA product code for Image-Intensified Fluoroscopic X-Ray System, Mobile, a class II device type, regulated under 21 CFR 892.1650. FDA's definition for this code reads: "Fluoroscopy of the human body". As of , FDA records hold 82 510(k) clearances under this code, the most recent dated , and 49 recalls.

Classification record

Product code
OXO
Device name
Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA definition
Fluoroscopy of the human body.
Regulation
21 CFR 892.1650
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
82
Ingested recalls
49

Clearances, product code OXO

By decision year
82 clearances under product code OXO with a decision year between 1976 and 2026, 2005 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code OXO by decision year
YearClearances
19761
19821
19881
19892
19904
19913
19922
19933
19943
19952
19964
19972
19983
19992
20003
20013
20021
20031
20043
20055
20062
20101
20124
20132
20142
20151
20163
20174
20181
20193
20212
20242
20254
20262

Applicants with the most clearances

Product code OXO
Applicants holding the most 510(k) clearances under product code OXO
ApplicantClearances
GE Healthcare8
Siemens Medical Solutions USA, Inc.7
Beijing East Whale Imaging Technology Co., Ltd.5
Orthoscan, Inc.5
Philips North America LLC5
GE Hualun Medical Systems Co., Ltd.4
Ziehm-Orthoscan, Inc.3
Acoma Medical Imaging, Inc.2
Breakaway Imaging, LLC2
Direx Systems Corp.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 64 companies shown, in name order