FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,433 results
12121–12144 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 09, 1992
COLLIMATOR LIGHT SOURCE
K924759 · IZT
Denar Corp.
Radiology · 77d
Cleared Dec 08, 1992
SONOMED 4000P ULTRASONIC PACHYMETER
K924311 · IYO
Sonomed, Inc.
Radiology · 104d
Cleared Dec 07, 1992
DU PONT COMPACT DAYLIGHT SYSTEM II (CDS II)
K924552 · IXW
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 89d
Cleared Dec 07, 1992
OPTITRACK
K924877 · KPS
Adac Laboratories
Radiology · 84d
Cleared Dec 07, 1992
SHIMADZU X-RAY TUBE STAND BH-100 SERIES
K925170 · IYB
Shimadzu Medical Systems
Radiology · 55d
Cleared Dec 04, 1992
MTV-250A, MTV-300A
K924478 · LMA
Toshiba America Medical Systems, In.C
Radiology · 92d
Cleared Dec 03, 1992
CEREBROVASCULAR DIAGNOSTIC SYSTEM
K914862 · IYN
Medasonics, Inc.
Radiology · 401d
Cleared Dec 03, 1992
CONVEX AND LINEAR ARRAY TRANSDUCERS
K923269 · IYO
Aloka Co., Ltd.
Radiology · 150d
Cleared Dec 03, 1992
MAXXUS
K924498 · KPS
GE Medical Systems
Radiology · 90d
Cleared Dec 03, 1992
CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARE
K924586 · IZD
Capintec Instruments, Inc.
Radiology · 84d
Cleared Dec 03, 1992
SHIMADZU RADIOGRAPJHIC STAND BR-100
K925169 · KPX
Shimadzu Medical Systems
Radiology · 51d
Cleared Dec 02, 1992
ANGIOGRAPHIC X-RAY SYSTEM
K922222 · IZI
Siemens Medical Solutions USA, Inc.
Radiology · 204d
Cleared Nov 30, 1992
NUCLEAR MEDICINE LASER IMAGER
K923536 · LMC
General Scanning, Inc.
Radiology · 137d
Cleared Nov 27, 1992
PULMOCATH INTRABRONCHIAL CATHETER
K901615 · JAQ
Omnitron Intl., Inc.
Radiology · 966d
Cleared Nov 27, 1992
ACUSON V714OR TRANSDUCER
K921341 · ITX
Acuson Corp.
Radiology · 252d
Cleared Nov 27, 1992
PLATO RADIATION THERAPY PLANNING SYSTEM
K921991 · IYE
Nucletron-Oldelft Corp.
Radiology · 213d
Cleared Nov 27, 1992
MODEL XCT-900 PQCT X-RAY BONE DENSITOMETER
K922286 · KGI
Norland Corp.
Radiology · 196d
Cleared Nov 27, 1992
IES, IMAGE ENHANCEMENT SYSTEM
K922470 · LNH
Open Mri, Inc.
Radiology · 185d
Cleared Nov 27, 1992
UROLOGICAL C-ARM TABLE, MODEL #056-450
K922591 · IXR
Biodan Medical Systems, Ltd.
Radiology · 178d
Cleared Nov 27, 1992
EXPOSET
K922977 · JAA
S & S Inficon, Inc.
Radiology · 163d
Cleared Nov 27, 1992
SIGNA BREAST COIL AND ARRAY ACCESSORY
K923025 · LNH
GE Medical Systems
Radiology · 157d
Cleared Nov 27, 1992
SENS-A-RAY
K923067 · EHD
Regam Medical Systems
Radiology · 155d
Cleared Nov 27, 1992
BODY BAND RESTRAINT STRAP SET
K923107 · JAA
Cook, Inc.
Radiology · 155d
Cleared Nov 27, 1992
KODAK X-OMAT FS-1A PROCESSOR
K923552 · IXW
Eastman Kodak Company
Radiology · 133d