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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,668 results
12961–12984 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 09, 1991
POWER SCAN 1000
K910802 · LNH
Webb Research, Inc.
Radiology · 72d
Cleared May 09, 1991
POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM
K911275 · KPS
Positron
Radiology · 48d
Cleared May 09, 1991
CT SYTEC 4000
K911387 · JAK
GE Medical Systems
Radiology · 41d
Cleared May 08, 1991
OMNICATH IMPLANTED CATHETER AND DEPOT
K911775 · KXK
Omnitron Intl., Inc.
Radiology · 37d
Cleared May 03, 1991
VARIAN ELECTRONIC PORTAL IMAGING SYSTEM
K901932 · IYE
Varian Assoc., Inc.
Radiology · 368d
Cleared May 03, 1991
Z XT RADIATION THERAPY TREATMENT TABLE
K910971 · JAI
Siemens Medical Laboratories, Inc.
Radiology · 57d
Cleared May 01, 1991
REAL TIME X-RAY IMAGING SYSTEM
K911082 · LMA
Siemens Medical Solutions USA, Inc.
Radiology · 51d
Cleared Apr 29, 1991
OLYMPUS JF-UM3-7.5/-12 AND CF-UM3-7.5/-12
K900880 · ITX
Olympus Corp.
Radiology · 427d
Cleared Apr 29, 1991
NORLAND XR26 WHOLE BODY OPTION
K901804 · KGI
Norland Corp.
Radiology · 374d
Cleared Apr 29, 1991
MULTILAB 2000
K904392 · JAF
Unetixs, Inc.
Radiology · 217d
Cleared Apr 29, 1991
S5192R TRANSDUCER
K904951 · MAA
Acuson Corp.
Radiology · 178d
Cleared Apr 29, 1991
UST-974-5 CONVEX TRANSDUCER
K911309 · ITX
Ge Medical Systems Information...
Radiology · 35d
Cleared Apr 24, 1991
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR 7501
K910437 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 83d
Cleared Apr 23, 1991
D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM
K904599 · JWM
Digital Design, Inc.
Radiology · 195d
Cleared Apr 23, 1991
GE QUADRATURE CERVICAL SPINE SURF COIL, M1285AR
K910817 · LNH
General Electric Co.
Radiology · 56d
Cleared Apr 23, 1991
KODAK EKTASCAN DIGITAL INTERFACE/FOR AT&T
K911405 · LMD
Eastman Kodak Company
Radiology · 25d
Cleared Apr 18, 1991
PLANMED SOPHIE
K904953 · IZH
Planmeca USA, Inc.
Radiology · 164d
Cleared Apr 18, 1991
VARIOUS TEMPLATE APPLICATORS
K910862 · IWJ
Best Industries
Radiology · 48d
Cleared Apr 18, 1991
SOPHYCAMERA DSX BODYTRAK
K911346 · IYX
Sopha Medical Systems, Inc.
Radiology · 22d
Cleared Apr 16, 1991
EMISSION TOMOGRAPHY CAROUSEL
K896151 · KPS
Atf Consolidated
Radiology · 539d
Cleared Apr 16, 1991
SHIMADZU IMAGE PROCESSOR DFS-500
K905132 · LLZ
Shimadzu Medical Systems
Radiology · 152d
Cleared Apr 16, 1991
VIDEO ANNOTATOR MODEL PK2310
K910384 · JAA
Perkins Mfg. Co.
Radiology · 77d
Cleared Apr 16, 1991
SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150K
K911339 · IZO
Shimadzu Medical Systems
Radiology · 21d
Cleared Apr 15, 1991
TRANSDUCERS, EUP-C318/V33/F334/CC331/B31/032T
K910268 · ITX
Hitachi Medical Corp.
Radiology · 90d