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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,488 results
10129–10152 of 15,488
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 29, 1998
RESTGRID PACKAGE/GYROSCAN NT
K982834 · LNH
Philips Medical Systems North...
Radiology · 78d
Cleared Oct 29, 1998
MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC
K982916 · MOS
Medrad, Inc.
Radiology · 71d
Cleared Oct 29, 1998
XCT 2000 L PQCT BONE DENSITOMETER
K983273 · KGI
Medical Systems, Inc.
Radiology · 42d
Cleared Oct 29, 1998
GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM
K983436 · JAQ
Gammamed USA
Radiology · 30d
Cleared Oct 29, 1998
WISE (II) IMAGE MANAGEMENT SYSTEM
K983447 · LMB
Sectra-Imtec AB
Radiology · 29d
Cleared Oct 28, 1998
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
K981528 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 182d
Cleared Oct 28, 1998
OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE
K982733 · ITX
The Olympus Optical Co.
Radiology · 84d
Cleared Oct 26, 1998
MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242
K982624 · IYE
Med-Tec,Inc.
Radiology · 90d
Cleared Oct 23, 1998
OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE
K982725 · ITX
Olympus America, Inc.
Radiology · 79d
Cleared Oct 22, 1998
VARISOURCE HENSCHKE TYPE GYN APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH...
K980590 · JAQ
Varian Medical Systems, Inc.
Radiology · 247d
Cleared Oct 22, 1998
JOINT MOTION DEVICE PACKAGE PN 1032,KNEEL CERVICAL PN 1026, LUMBAR 1027,...
K982761 · LNH
Chamco, Inc.
Radiology · 77d
Cleared Oct 22, 1998
ORTHOPHOS 5/PLUS/CD
K983057 · MUH
Sirona Dental Systems GmbH
Radiology · 51d
Cleared Oct 21, 1998
VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH...
K980601 · JAQ
Varian Assoc., Inc.
Radiology · 246d
Cleared Oct 21, 1998
ASTEION CT SCANNER, TSX-021A
K982787 · JAK
Toshiba America Medical Systems, In.C
Radiology · 72d
Cleared Oct 21, 1998
RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE
K982862 · LLZ
Applicare Medical Imaging, B.V.
Radiology · 69d
Cleared Oct 20, 1998
DX-480, ADD ON DIGITAL IMAGER
K981880 · KPR
Wuestec Medical, Inc.
Radiology · 145d
Cleared Oct 15, 1998
SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL
K982772 · MOS
Ge Medical Systems, Inc.
Radiology · 69d
Cleared Oct 15, 1998
FILM DIGITIZER MODEL 2905
K982785 · LMA
Array Corp.
Radiology · 69d
Cleared Oct 09, 1998
RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY
K981597 · IYE
Radionics, Inc.
Radiology · 158d
Cleared Oct 09, 1998
ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS
K983327 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 17d
Cleared Oct 08, 1998
BARCO MEDIS 5MP 5 MEGAPIXEL MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K982820 · LLZ
Barco NV Display Systems
Radiology · 58d
Cleared Oct 08, 1998
PHASED ARRAY CERVICAL SPINE COIL, MODEL #125GE-64
K983222 · MOS
Medical Advances, Inc.
Radiology · 23d
Cleared Oct 06, 1998
DIGITAL RADIOGRAPHIC IMAGING SYSTEM
K982196 · KPR
GE Medical Systems
Radiology · 106d
Cleared Oct 06, 1998
E.CAM EXTRA HIGH ENERGY COLLIMATOR
K982387 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 89d