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
9145–9168 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 13, 2002
MAMMOPATH
K021113 · MWP
Fischer Imaging Corp.
Radiology · 69d
Cleared Jun 13, 2002
MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL
K021433 · MOS
Medical Advances, Inc.
Radiology · 38d
Cleared Jun 13, 2002
HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4
K021656 · KPS
Nuclear Diagnostics
Radiology · 24d
Cleared Jun 12, 2002
HNC-127-TRIO NEUROVASCULAR ARRAY COIL
K021570 · MOS
Mri Devices Corp.
Radiology · 29d
Cleared Jun 12, 2002
OBC-127 BREAST ARRAY COIL
K021575 · MOS
Mri Devices Corp.
Radiology · 29d
Cleared Jun 07, 2002
TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB
K020783 · LHQ
Telesis Technologies, Inc.
Radiology · 88d
Cleared Jun 07, 2002
VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY
K021372 · EAG
J. Morita USA, Inc.
Radiology · 38d
Cleared Jun 07, 2002
PORTABLE HDX INTRAORAL X-RAY
K021378 · EHD
Dentalez Group
Radiology · 37d
Cleared Jun 07, 2002
SECTRA OSTEOPOROSIS PACKAGE
K021527 · KGI
Sectra-Imtec AB
Radiology · 28d
Cleared Jun 06, 2002
GPF-29 GENERAL PURPOSE COIL SET
K020850 · MOS
Mri Devices Corp.
Radiology · 83d
Cleared Jun 06, 2002
M3 (MICRO-MULTILEAF COLLIMATOR)
K020860 · IYE
Brainlab AG
Radiology · 80d
Cleared Jun 06, 2002
DCM 2.0
K020971 · MUJ
Mds Nordion AB
Radiology · 72d
Cleared Jun 06, 2002
MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS
K021021 · JAA
Siemens Medical Solutions USA, Inc.
Radiology · 69d
Cleared Jun 06, 2002
FILMSAVER, NT VERSION 5.03
K021072 · LLZ
American Medical Resources, Ltd. (Amr)
Radiology · 65d
Cleared Jun 06, 2002
MODEL 1133 IVD PC VERSION
K021463 · IYE
Sun Nuclear Corp.
Radiology · 30d
Cleared Jun 05, 2002
U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000
K013902 · IYN
U-Systems, Inc.
Radiology · 191d
Cleared Jun 05, 2002
PHYSICIAN'S DESKTOP REVIEW
K021669 · LLZ
Adac Laboratories
Radiology · 15d
Cleared May 31, 2002
SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES)
K021628 · IYN
Sonosite,Inc.
Radiology · 14d
Cleared May 28, 2002
EZ-SCOPE AN & EZ-SCOPE AN LITE
K020643 · IYX
Health Policy Resorters Group, LLC
Radiology · 90d
Cleared May 23, 2002
MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT...
K021286 · JAQ
Nucletron Corp.
Radiology · 30d
Cleared May 22, 2002
ECLIPSE, HELIOS OPTION
K021268 · MUJ
Varian Medical Systems, Inc.
Radiology · 30d
Cleared May 22, 2002
HISPEED DUAL
K021491 · JAK
Ge Medical Systems, Inc.
Radiology · 13d
Cleared May 21, 2002
SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW
K013897 · MQB
Bio-Scan S.A
Radiology · 179d
Cleared May 21, 2002
INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND...
K020790 · MOS
Surgi-Vision, Inc.
Radiology · 71d