FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
5401–5424 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 23, 2013
DISCOVERY MR750W 3.0T
K130115 · LNH
Ge Medical Systems, LLC
Radiology · 127d
Cleared May 22, 2013
ANYTHINK PACS WORKSTATION
K131299 · LLZ
Beijing Crealife Technology Co., Ltd.
Radiology · 15d
Cleared May 21, 2013
ALLURA XPER FD OR TABLE SERIES
K130842 · IZI
Philips Medical Systems Nederland B.V.
Radiology · 55d
Cleared May 20, 2013
3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL
K130457 · MOS
Resonance Innovations, LLC
Radiology · 87d
Cleared May 20, 2013
NORDIC TUMOREX
K123306 · LLZ
Nordicneurolab
Radiology · 208d
Cleared May 17, 2013
MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT
K130885 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared May 17, 2013
NEUROQ 3.6
K130451 · KPS
Syntermed, Inc.
Radiology · 84d
Cleared May 17, 2013
KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
K130377 · MQB
Medicatech USA
Radiology · 92d
Cleared May 17, 2013
THE VAULT SYSTEM
K124051 · LLZ
Somersault Orthopedics, Inc.
Radiology · 137d
Cleared May 17, 2013
OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME
K123603 · OXO
Ge Healthcare Surgery GE Oec Medical...
Radiology · 177d
Cleared May 17, 2013
MAGNETOM SKYRA
K123510 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 185d
Cleared May 16, 2013
4D VIEW
K131118 · LLZ
Ge Healthcare
Radiology · 24d
Cleared May 16, 2013
MOBILECT VIEWER
K123082 · LLZ
Nephosity, Inc.
Radiology · 227d
Cleared May 16, 2013
ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21
K122644 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 260d
Cleared May 16, 2013
PORTABLE X-RAY SYSTEM
K122124 · EHD
Osstem Implant Co., Ltd.
Radiology · 302d
Cleared May 14, 2013
SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100
K123985 · JAD
Sensus Healthcare
Radiology · 139d
Cleared May 14, 2013
KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE APPLICATOR SET
K123912 · JAQ
Spencer Fillmore
Radiology · 146d
Cleared May 13, 2013
QLAB QUANTIFICATION SOFTWARE HEART MODEL
K130159 · LLZ
Philips Health Care
Radiology · 110d
Cleared May 10, 2013
RAYSTATION
K130617 · MUJ
Raysearch Laboratories AB
Radiology · 64d
Cleared May 10, 2013
HYPERION X9
K123381 · OAS
Cefla S.C.
Radiology · 190d
Not Cleared May 09, 2013
X-RAY ATTENUATING CREAM
DEN120022 · PDK
Bloxr Corporation
Radiology · 183d
Cleared May 07, 2013
CONI
K130624 · LLZ
Globalmed
Radiology · 60d
Cleared May 03, 2013
ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER
K121243 · IYO
MEDA Co., Ltd.
Radiology · 373d
Cleared May 02, 2013
AQUILION LB TRITON V4.91
K123500 · JAK
Toshibamedical Systems Corporation
Radiology · 170d