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
7417–7440 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 22, 2007
AOS MARKER SEEDS
K062825 · KXK
Alpha-Omega Services, Inc.
Radiology · 244d
Cleared May 22, 2007
AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS
K062826 · JAQ
Alpha-Omega Services, Inc.
Radiology · 244d
Cleared May 22, 2007
VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION
K070831 · LLZ
Barcoview Mis Edinburgh
Radiology · 57d
Cleared May 22, 2007
FUJI IP CASSETTE TYPE PC
K070920 · IYE
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 50d
Cleared May 22, 2007
RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK4
K071054 · LLZ
Volume Interactions Pte, Ltd.
Radiology · 36d
Cleared May 22, 2007
.DECIMAL RANGE COMPENSATOR
K071078 · IXI
.Decimal, Inc.
Radiology · 35d
Cleared May 22, 2007
NEURO II-SE, MODELS: OR-DR-OR, OR-MB
K071099 · LNH
Imris, Inc.
Radiology · 33d
Cleared May 22, 2007
SYNGO IMAGING (VERSION V30)
K071114 · LLZ
Siemens AG Medical Solutions
Radiology · 32d
Cleared May 22, 2007
NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL
K071311 · MOS
Neocoil
Radiology · 13d
Cleared May 22, 2007
SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS
K071314 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 12d
Cleared May 18, 2007
CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS)
K070834 · OWB
Omega Medical Imaging, Inc.
Radiology · 52d
Cleared May 18, 2007
.DECIMAL APERTURE
K071077 · IXI
.Decimal, Inc.
Radiology · 31d
Cleared May 18, 2007
SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6
K071204 · IYO
C.R. Bard, Inc.
Radiology · 17d
Cleared May 18, 2007
SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY
K071229 · JAQ
Senorx, Inc.
Radiology · 15d
Cleared May 17, 2007
BLADDERSCAN BVI 9400 ULTRASOUND
K071217 · IYO
Verathon Incorporated
Radiology · 15d
Cleared May 16, 2007
MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM
K071036 · IYN
Siemens Medical Solutions USA, Inc.,...
Radiology · 34d
Cleared May 15, 2007
LMS-LUNG/TRACK
K070868 · LLZ
Median Technologies
Radiology · 47d
Cleared May 14, 2007
MYRIAN
K071000 · LLZ
Intrasense
Radiology · 35d
Cleared May 14, 2007
BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197
K071068 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared May 10, 2007
OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM
K071015 · IZL
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared May 10, 2007
SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000
K071037 · IZI
Novadaq Technologies, Inc.
Radiology · 28d
Cleared May 10, 2007
SUPERSTAR 0.35T MRI SYSTEM
K071154 · LNH
Neusoft Medical Systems Co., Ltd.
Radiology · 15d
Cleared May 09, 2007
SYNEPIX 4600 DETECTOR
K070829 · MQB
Analogic Corporation
Radiology · 44d
Cleared May 08, 2007
INTERWORKS
K070755 · LLZ
Avreo, Inc.
Radiology · 50d