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
11353–11376 of 15,520
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 05, 1995
VARIAN MULTILEAF COLLIMATOR, RELEASE 4.0
K926449 · IYE
Varian Assoc., Inc.
Radiology · 862d
Cleared May 05, 1995
INSTASPOT
K942504 · LLZ
Fidelity Medical, Inc.
Radiology · 344d
Cleared May 05, 1995
TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA
K945318 · ITX
Tetra Corp.
Radiology · 185d
Cleared May 04, 1995
SYSTEM, IMAGE PROCESSING
K943156 · JAA
Image Technology, Inc.
Radiology · 308d
Cleared May 04, 1995
VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300)
K944004 · IYO
Endosonics Corp.
Radiology · 261d
Cleared May 04, 1995
TETRAD MODEL BS18, ENDOSURGICAL NEEDLE GUIDE ATTACHMENT
K945319 · ITX
Tetra Corp.
Radiology · 184d
Cleared May 04, 1995
BCM 400CP
K946378 · IZI
B C Medical , Ltd.
Radiology · 132d
Cleared May 04, 1995
LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM
K950431 · LMD
Open Mri, Inc.
Radiology · 91d
Cleared May 04, 1995
KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2)
K951005 · IZQ
Kenex , Ltd.
Radiology · 78d
Cleared May 04, 1995
IMAGING TABLE
K951146 · KXJ
Septa Corp.
Radiology · 52d
Cleared May 04, 1995
PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE)
K951372 · IZW
Philips Medical Systems, Inc.
Radiology · 38d
Cleared May 03, 1995
QCT-BONE MINERAL ANALYSIS PHANTOM
K941126 · KGI
Image Analysis, Inc.
Radiology · 420d
Cleared May 03, 1995
BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSI
K944978 · IZH
Bennett X-Ray Corp.
Radiology · 204d
Cleared May 03, 1995
PREVIEW TELEIMAGING SYSTEM
K950699 · LMD
Regulatory Management Services
Radiology · 77d
Cleared Apr 28, 1995
SENSORI-MOTOR RATING SCALE
K946114 · IXY
Cmed
Radiology · 134d
Cleared Apr 27, 1995
PQ5000 CT SYSTEM
K943623 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 275d
Cleared Apr 26, 1995
VANTAGE, FOR ADAC GAMMA CAMERAS
K943596 · KPS
Adac Laboratories
Radiology · 275d
Cleared Apr 25, 1995
HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT
K930265 · LNI
GE Medical Systems
Radiology · 826d
Cleared Apr 25, 1995
LUNAR EXPERT
K945526 · KGI
Lunar Corp.
Radiology · 166d
Cleared Apr 25, 1995
FIKO FO
K950610 · LMC
Fujifilm Medical System U.S.A., Inc.
Radiology · 74d
Cleared Apr 20, 1995
MRT-50 QD BODY COIL
K945875 · LNH
Toshiba America Mri, Inc.
Radiology · 140d
Cleared Apr 20, 1995
KOORDINAT M
K951176 · IXR
Siemens Medical Solutions USA, Inc.
Radiology · 36d
Cleared Apr 19, 1995
UPSCAN
K933512 · KPR
Merlin Engineering Works, Inc.
Radiology · 638d
Cleared Apr 19, 1995
TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY
K950532 · EAP
Trophy Radiologie
Radiology · 71d