FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
5521–5544 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 02, 2013
GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY...
K122457 · OWB
Ge Healthcare
Radiology · 142d
Cleared Jan 02, 2013
INTERVENTIONAL WORKSPOT
K121296 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 247d
Cleared Jan 01, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA
K122919 · MQB
Rayence Co., Ltd.
Radiology · 99d
Cleared Dec 28, 2012
ONQ RTS
K123357 · MUJ
Oncology Systems, Inc.
Radiology · 58d
Cleared Dec 28, 2012
RAPID STRAND RX
K122764 · KXK
Medi-Physics, Inc.
Radiology · 109d
Cleared Dec 27, 2012
CLEARREAD +CONFIRM
K123526 · LLZ
Riverain Technologies
Radiology · 42d
Cleared Dec 27, 2012
EVA SELECT DIGITAL DENTAL IMAGING SYSTEM
K123419 · MUH
Afp Imaging Corp.
Radiology · 51d
Cleared Dec 27, 2012
VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T
K123091 · MOS
Imris, Inc.
Radiology · 86d
Cleared Dec 27, 2012
SYNGO SINGLE SOURCE DUAL ENGERY
K122909 · JAK
Siemens Medical Systems, Inc.
Radiology · 97d
Cleared Dec 27, 2012
INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS
K121653 · JAD
Carl Zeiss Meditec, Inc.
Radiology · 205d
Cleared Dec 21, 2012
CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM
K123754 · IYN
Philips Ultrasound, Inc.
Radiology · 15d
Cleared Dec 21, 2012
PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM
K123616 · IYO
Sonoscape Company Limited
Radiology · 28d
Cleared Dec 21, 2012
E-CUBE 7
K123611 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 30d
Cleared Dec 21, 2012
SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646
K122897 · MOS
Invivo Corporation
Radiology · 91d
Cleared Dec 21, 2012
PANTHER OIS/R & V MODEL VERSION 2.0
K122616 · IYE
Prowess, Inc.
Radiology · 116d
Cleared Dec 21, 2012
SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED...
K122106 · JAK
Veran Medical Technologies, Inc.
Radiology · 157d
Cleared Dec 21, 2012
PREXION 3D
K120948 · OAS
The Yoshida Dental Mfg. Co., Ltd.
Radiology · 267d
Cleared Dec 20, 2012
SYNGO, CT CARDIAC FUNCTION
K123585 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Dec 20, 2012
MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)
K123530 · LLZ
Hologic, Inc.
Radiology · 34d
Cleared Dec 20, 2012
SCENIUM
K123528 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 34d
Cleared Dec 20, 2012
AEROPILOT
K123499 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 37d
Cleared Dec 20, 2012
TRUEBEAM
K123291 · IYE
Varian Medical Systems, Inc.
Radiology · 59d
Cleared Dec 18, 2012
LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
K123564 · IYN
Ge Healthcare
Radiology · 28d
Cleared Dec 18, 2012
HERMES MEDICAL IMAGING SUITE V5.2
K121278 · KPS
Hermes Medical Solutions AB
Radiology · 232d