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
11761–11784 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 14, 1993
IMPAX 3000
K934832 · JAK
Heraeus Kulzer, Inc.
Radiology · 67d
Cleared Dec 13, 1993
RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U
K923697 · KXK
Radionics, Inc.
Radiology · 507d
Cleared Dec 13, 1993
PRACTICE PARTNER
K926315 · LMD
Rs Imaging
Radiology · 363d
Cleared Dec 13, 1993
MODEL 500-6 RADIATION THERAPY IONIZATION CHAMBER
K932342 · LNN
Victoreen, Inc.
Radiology · 213d
Cleared Dec 13, 1993
HEARTVIEW(R) CORONARY ANGIOGRAPH DIAGRAM/REPORT SY
K932410 · IZI
Heartware Intl. Corp.
Radiology · 209d
Cleared Dec 13, 1993
PHILIPS GYROSCAN TN5 & TN5 LITE
K932644 · LNH
Philips Medical Systems, Inc.
Radiology · 194d
Cleared Dec 13, 1993
PHILIPS GYROSCAN TN 15
K932645 · LNH
Philips Medical Systems, Inc.
Radiology · 194d
Cleared Dec 13, 1993
MEDSCAN 12
K933632 · LMA
Vidar Systems Corp.
Radiology · 139d
Cleared Dec 13, 1993
CONCEPT ONE
K933777 · IZO
Innerscan, Inc.
Radiology · 132d
Cleared Dec 13, 1993
WHITMORE ANKLE X-RAY EXTENSION (AXE)
K933778 · KPR
Whitmore Ent., Inc.
Radiology · 132d
Cleared Dec 13, 1993
INTRASCAN(R) MINI-PACS
K934311 · IYO
Markcare Medical Systems, Inc.
Radiology · 103d
Cleared Dec 13, 1993
X-RAY ANGIOGRAPHIC SYSTEM
K934496 · IZI
Camtronics, Ltd.
Radiology · 89d
Cleared Dec 13, 1993
RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM
K934519 · IWE
Medtec, Inc.
Radiology · 87d
Cleared Dec 13, 1993
SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATOR
K934967 · IZO
Shimadzu Corp.
Radiology · 59d
Cleared Dec 13, 1993
MODEL ALPHA TS-2
K935004 · IYB
Dpa Consulting, Inc.
Radiology · 55d
Cleared Dec 13, 1993
RADIOGRAPHIC GENERATOR HFQ-WHIS
K935068 · IZO
Bennett X-Ray Corp.
Radiology · 49d
Cleared Dec 13, 1993
INSTA-FLO
K935209 · JAD
Medtec, Inc.
Radiology · 45d
Cleared Dec 10, 1993
CVI-Q(TM) OPTION FOR P700
K924184 · IYO
Philips Medical Systems, Inc.
Radiology · 477d
Cleared Dec 02, 1993
OE 1.5 SI
K925858 · LNH
Otsuka Electronics
Radiology · 380d
Cleared Nov 24, 1993
MEDISON 1500
K924432 · IYO
Medison Co., Ltd.
Radiology · 449d
Cleared Nov 24, 1993
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR AUD150G
K933471 · IZO
Shimadzu Corp.
Radiology · 132d
Cleared Nov 24, 1993
CATHETERIZATION C-ARM SUPPORT MH-51BM/MH-51CM
K933473 · JAA
Shimadzu Corp.
Radiology · 132d
Cleared Nov 24, 1993
R &D BATTERIES, INC. PART # 5015, 5192, 5482
K933513 · IYX
R & D Batteries, Inc.
Radiology · 127d
Cleared Nov 24, 1993
SHIMADZU CEILING TUBE SUPPORT CH-30GX
K934005 · KPR
Shimadzu Corp.
Radiology · 98d