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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,520 results
12769–12792 of 15,520
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 24, 1991
SONO-VU US(TM)
K904583 · HIO
E-Z-Em, Inc.
Radiology · 258d
Cleared Jun 24, 1991
L582 TRANSDUCER
K904600 · MAA
Acuson Corp.
Radiology · 257d
Cleared Jun 24, 1991
POCKET DOP 3
K910462 · HEP
Imex Medical Systems, Inc.
Radiology · 140d
Cleared Jun 21, 1991
AGFA DIAGNOSTIC CENTER (ADC)
K904519 · LLZ
Enhanced Imaging Technologies, Inc.
Radiology · 261d
Cleared Jun 21, 1991
NDI MODEL IRS-TD
K904676 · KPR
National Diagnostic Imaging, Inc.
Radiology · 252d
Cleared Jun 21, 1991
MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM
K905074 · IYX
Siemens Gammasonics, Inc.
Radiology · 224d
Cleared Jun 21, 1991
BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET
K905518 · IZI
Venusa , Ltd.
Radiology · 196d
Cleared Jun 21, 1991
RIGID ENDOSCOPE
K911348 · LNH
Bruel & Kjaer
Radiology · 86d
Cleared Jun 21, 1991
MAGNETIC RESONANCE DEVICE ACCESSORY (MRT-50A)
K911495 · LNH
Toshiba America Mri, Inc.
Radiology · 78d
Cleared Jun 20, 1991
OBTRASOUND STETHOSCOPE FETAL CALC
K911453 · KNG
Medasonics, Inc.
Radiology · 78d
Cleared Jun 20, 1991
RX-5000 MRI SYSTEM
K911892 · LNH
Resonex, Inc.
Radiology · 55d
Cleared Jun 19, 1991
VARIOUS X-RAY TUBES
K911695 · ITY
Comet Ltd. C/O Radiology Resources, Inc.
Radiology · 64d
Cleared Jun 17, 1991
MULTISPECT 3 TRIPLE DETECTOR CAMERA SYSTEM
K911078 · KPS
Siemens Gammasonics, Inc.
Radiology · 98d
Cleared Jun 17, 1991
SI-1200 / ILUS
K911200 · IYO
Siemens Ultrasound, Inc.
Radiology · 90d
Cleared Jun 17, 1991
SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150B
K911280 · IZO
Shimadzu Medical Systems
Radiology · 84d
Cleared Jun 14, 1991
CW DOPPLER/4.5 MHZ
K903984 · ITX
Diasonics, Inc.
Radiology · 289d
Cleared Jun 13, 1991
NUCLETRON PLANNING SYSTEM
K911612 · IYE
Nucletron-Oldelft Corp.
Radiology · 63d
Cleared Jun 12, 1991
PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA
K904573 · ODG
Pentax Precision Instrument Corp.
Radiology · 246d
Cleared Jun 11, 1991
LABSONICS MAMM-O-MATE MODEL NO. 918084-1, MODIFIED
K905522 · IYO
Laboratory Equipment Corp.
Radiology · 183d
Cleared Jun 10, 1991
QDR-1000 AND QDR-1000/W X-RAY BONE DENSITOMETER
K905753 · KGI
Hologic, Inc.
Radiology · 168d
Cleared Jun 10, 1991
RADIOACTIVE SEEDS
K910710 · KXK
Best Assoc. Corp.
Radiology · 110d
Cleared Jun 10, 1991
SONARSCAN 128 ULTRASOUND SCANNER
K911107 · IYO
Diagnostic Sonar USA
Radiology · 90d
Cleared Jun 07, 1991
VISTA HPQ SYSTEM
K910715 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 107d
Cleared Jun 07, 1991
KODAK AUTOMATIC FILM FEEDER, MODEL RA
K911711 · IXW
Eastman Kodak Company
Radiology · 51d