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
10105–10128 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 14, 1999
EXCELART
K990620 · LNH
Toshiba America Mri, Inc.
Radiology · 78d
Cleared May 13, 1999
UROMED BRACHYTHERAPHY IODINE-125 SOURCES
K982226 · KXK
Uromed Corp.
Radiology · 323d
Cleared May 13, 1999
DMD DIGITAL X-RAY SYSTEM
K990087 · MUH
Dental/Medical Diagnostic Systems, Inc.
Radiology · 122d
Cleared May 13, 1999
HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL
K991129 · KPS
Hitachi Medical Corp. of America
Radiology · 41d
Cleared May 13, 1999
PHILIPS TOMOSCAN AV-NT
K991278 · JAK
Philips Medical Systems North...
Radiology · 29d
Cleared May 12, 1999
ROCS ULTRASEED
K984241 · IYE
Radiation Oncology Computer Systems
Radiology · 166d
Cleared May 12, 1999
CALCIUM SCORING
K990426 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared May 12, 1999
PHILIPS EASY VISION FAMILY WORKSTATION LEGS OPTION
K990455 · LLZ
Philips Medical Systems, Inc.
Radiology · 89d
Cleared May 11, 1999
ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3
K990442 · LLZ
Vital Images, Inc.
Radiology · 90d
Cleared May 11, 1999
3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
K990550 · LNH
Ge Medical Systems, Inc.
Radiology · 78d
Cleared May 05, 1999
SCANFLEX SOLID COUPLANT MEMBRANE
K983691 · ITX
Sonotech, Inc.
Radiology · 197d
Cleared May 05, 1999
CTS-310(B)
K984161 · IYO
Shantou Institute of Ultrasonic...
Radiology · 166d
Cleared May 05, 1999
APOLLO 5, APOLLO 10
K990383 · IYE
Precitron A.B.
Radiology · 86d
Cleared Apr 30, 1999
AU6
K990360 · IYN
Biosound Esaote, Inc.
Radiology · 84d
Cleared Apr 30, 1999
ORTHOPHOS 3/3 CEPH/3 DS
K990528 · MUH
Sirona Dental Systems GmbH
Radiology · 70d
Cleared Apr 21, 1999
THORAX FD AND MULTIX FD
K983732 · MQB
Siemens Medical Solutions USA, Inc.
Radiology · 181d
Cleared Apr 21, 1999
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION
K984156 · JAK
Shimadzu Medical Systems
Radiology · 153d
Cleared Apr 21, 1999
SHEATHES (NON-LATEX), STERILE
K990175 · ITX
Sheathing Technologies, Inc.
Radiology · 92d
Cleared Apr 20, 1999
FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095
K983338 · JAQ
Nucletron Corp.
Radiology · 209d
Cleared Apr 16, 1999
BEACON, MODEL 211060
K983948 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 162d
Cleared Apr 16, 1999
`BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH
K984446 · KXK
Urocor, Inc.
Radiology · 123d
Cleared Apr 16, 1999
DICOM IMAGE MANAGER, MODEL 3-D VISUALIZATION OPTION
K990248 · IYO
Dicomit Imaging Systems Corp.
Radiology · 80d
Cleared Apr 16, 1999
SHIMADZU CEILING TUBE SUPPORT CH-30GH
K990715 · KPR
Shimadzu Corp.
Radiology · 43d
Cleared Apr 15, 1999
STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR...
K983341 · JAQ
Nucletron Corp.
Radiology · 204d