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
10153–10176 of 15,488
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 06, 1998
7250 ULTRASOUND IMAGING SYSTEM
K982444 · IYO
Biosound Esaote, Inc.
Radiology · 84d
Cleared Oct 06, 1998
ULTRAPRO MODEL 98
K982563 · LLZ
Ramsoft, Inc.
Radiology · 75d
Cleared Oct 06, 1998
PHILIPS TOMOSCAN CS
K982631 · JAK
Philips Medical Systems, Inc.
Radiology · 70d
Cleared Oct 06, 1998
BARCO MEDICAL DISPLAY CONFORMITY AND CONSISTENCY SOFTWARE
K982690 · LLZ
Barco N.V.
Radiology · 64d
Cleared Oct 06, 1998
MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64:...
K983109 · MOS
Medical Advances, Inc.
Radiology · 32d
Cleared Oct 05, 1998
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXL
K982583 · JAK
Shimadzu Corp.
Radiology · 73d
Cleared Oct 05, 1998
OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE
K982734 · ODG
The Olympus Optical Co.
Radiology · 61d
Cleared Sep 30, 1998
SOMATOM PLUS 4WITH VOLUME ZOOM CT SCANNERS
K982349 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 86d
Cleared Sep 30, 1998
EAGLESOFT CHAIRSIDE
K982422 · LLZ
Eaglesoft, A Patterson Co.
Radiology · 79d
Cleared Sep 30, 1998
EXTRACRANIAL RADIOTHERAPY SYSTEM
K982463 · IYE
Howmedica, Inc.
Radiology · 77d
Cleared Sep 29, 1998
COMBISON 530D WITH POWER DOPPLER MODE
K974813 · IYN
Medison America, Inc.
Radiology · 280d
Cleared Sep 29, 1998
XKNIFE-4
K981055 · IYE
Radionics, Inc.
Radiology · 190d
Cleared Sep 29, 1998
AUTOMATED MEDICAL REPORT WRITER
K981553 · KPS
Woodson and Associates, LLC
Radiology · 151d
Cleared Sep 29, 1998
PERCEPTION INC, GPS-6TBMD DIAGNOSTIC ULTRASOUND SYSTEM
K981834 · IYN
Perception, Inc.
Radiology · 126d
Cleared Sep 29, 1998
DYNAMIC SHIELDING RADIATION TABLE
K982446 · JAI
American Biophysics, Inc.
Radiology · 76d
Cleared Sep 29, 1998
PHILIPS OMNIDIAGNOST
K982993 · OWB
Philips Medical Systems, Inc.
Radiology · 33d
Cleared Sep 28, 1998
PGK DEVICE (MODIFIED)
K980997 · IWJ
Pgk, Inc.
Radiology · 195d
Cleared Sep 25, 1998
TRANSVIEW (TRANSMISSION SYSTEM),MODEL NDTR-701A
K982300 · KPS
Toshiba America Medical Systems, In.C
Radiology · 86d
Cleared Sep 23, 1998
ULTRA-COVER PU-TRANSDUCER COVER
K981069 · ITX
International Medical Products B.V.
Radiology · 183d
Cleared Sep 23, 1998
TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING...
K982427 · OWB
Trex Medical Corp.
Radiology · 72d
Cleared Sep 22, 1998
CAREGRAPH
K982319 · JAA
Siemens Medical Solutions USA, Inc.
Radiology · 82d
Cleared Sep 22, 1998
ECTON LYNX ULTRASOUND SYSTEM
K982800 · IYO
Ecton, Inc.
Radiology · 43d
Cleared Sep 22, 1998
INSTACINE D-2000
K983088 · LLZ
Fidelity Medical, Inc.
Radiology · 25d
Cleared Sep 18, 1998
QUADRATURE LOWER EXTREMITY COIL, MODEL # 473SI-42D
K982496 · MOS
Medical Advances, Inc.
Radiology · 63d