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
5545–5568 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 11, 2013
1.5T GEM RT OPEN ARRAY
K123327 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 77d
Cleared Jan 11, 2013
IB CLINIC
K123302 · LLZ
Imaging Biometrics, LLC
Radiology · 80d
Cleared Jan 11, 2013
VIVIX-S WITH VXVUE
K122866 · MQB
Vieworks Co., Ltd.
Radiology · 115d
Cleared Jan 11, 2013
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
K122836 · IZH
Lorad, A Hologic Co.
Radiology · 116d
Cleared Jan 09, 2013
BEST LOCALIZATION NEEDLE WITH I-125 SEED
K122704 · KXK
Best Medical Intl.
Radiology · 127d
Cleared Jan 08, 2013
ALIGNRT PLUS
K123371 · IYE
Vision RT Limited
Radiology · 68d
Cleared Jan 07, 2013
VANTAGE MODEL V5000, V5100, V5000C, V5100C
K122643 · MUH
Midmark Corp.
Radiology · 131d
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