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
9841–9864 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 14, 2000
BARCOMED 5MP1H
K000014 · LLZ
Barco N.V.
Radiology · 71d
Cleared Mar 14, 2000
BARCOMED 5MP2
K000016 · LLZ
Barco N.V.
Radiology · 71d
Cleared Mar 14, 2000
POCKET ULTRASONIC OPHTHALMIC PACHYMETER, BIOMETRY TRANSDUCER FOR POCKET
K000554 · IYO
Quantel Medical
Radiology · 25d
Cleared Mar 14, 2000
MODEL 445SI-64E QUADRATURE WRIST COIL
K000589 · MOS
Igc-Medical Advances, Inc.
Radiology · 21d
Cleared Mar 14, 2000
PROSTEC 125I BRACHYTHERAPY SEEDS
K993280 · KXK
Prostec, LLC
Radiology · 166d
Cleared Mar 14, 2000
ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200...
K994285 · EHD
Dentsply Intl.
Radiology · 85d
Cleared Mar 14, 2000
SURGI-VISION ESOPHAGEAL STYLET COIL
K994436 · MOS
Surgi-Vision, Inc.
Radiology · 75d
Cleared Mar 09, 2000
ULTRASOUND SCANNER TYPE 2102
K000567 · IYO
B & K Medical A/S
Radiology · 16d
Cleared Mar 09, 2000
BRACHYVISION 6.0
K992762 · MUJ
Varian Assoc., Inc.
Radiology · 205d
Cleared Mar 09, 2000
PEGASYS ULTRA
K993946 · LLZ
Adac Laboratories
Radiology · 111d
Cleared Mar 09, 2000
INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000
K994270 · LLZ
Visualization Technology, Inc.
Radiology · 80d
Cleared Mar 07, 2000
CODE AC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA...
K994167 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 89d
Cleared Mar 07, 2000
AIRIS II
K994378 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 71d
Cleared Mar 02, 2000
MRI- FLOW ANALYTICAL SOFTWARE PACKAGE
K994282 · LNH
Medis Medical Imaging Systems BV
Radiology · 73d
Cleared Feb 24, 2000
OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM
K000034 · IYN
Optimal Imaging Systems, Inc.
Radiology · 49d
Cleared Feb 24, 2000
7250 (MEGAS)
K994369 · IYN
Biosound Esaote, Inc.
Radiology · 59d
Cleared Feb 23, 2000
MAGNA 5000 PHASED ARRAY CTL SPINE COIL
K000002 · MOS
Usa Instruments, Inc.
Radiology · 51d
Cleared Feb 22, 2000
10 CURIE IRDIUM 192, CSN00100-192
K991571 · KXK
Alpha-Omega Services, Inc.
Radiology · 293d
Cleared Feb 22, 2000
REMOTEIMAGE SYSTEM
K994228 · LLZ
Etrauma.Com Corp.
Radiology · 69d
Cleared Feb 16, 2000
AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO
K000159 · IXK
Agfa Corp.
Radiology · 28d
Cleared Feb 16, 2000
SOMAVISION
K992751 · KPQ
Varian Assoc., Inc.
Radiology · 184d
Cleared Feb 15, 2000
LIGHTSPEED 2.0CT SCANNER SYSTEM
K000300 · JAK
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Feb 14, 2000
LCV+ VERSION 2
K993037 · OWB
Ge Medical Systems, Inc.
Radiology · 158d
Cleared Feb 14, 2000
IDX-60 INTRAORAL X-RAY
K993958 · MUH
X-Cel X-Ray Corp.
Radiology · 84d