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
13441–13464 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 20, 1988
VOXELSCOPE(TM)
K884268 · JAK
Dynamic Digital Displays, Inc.
Radiology · 70d
Cleared Dec 20, 1988
MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM
K884317 · JAA
Medrad, Inc.
Radiology · 68d
Cleared Dec 15, 1988
UROIMAGER
K883925 · IYO
Ausonics Pty , Ltd.
Radiology · 90d
Cleared Dec 14, 1988
WWDS-005 HUMAN RECTAL PROBE
K883079 · IYO
Ausonics Pty , Ltd.
Radiology · 146d
Cleared Dec 13, 1988
CFX 625
K883976 · IZO
Fischer Imaging Corp.
Radiology · 84d
Cleared Dec 12, 1988
SDU-500 DIAGNOSTIC ULTRASOUND INSTRUMENT
K875187 · IYO
Shimadzu Corp.
Radiology · 356d
Cleared Dec 05, 1988
MT/S (SPINE TRANSMIT COIL)
K884606 · LNH
Diasonics, Inc.
Radiology · 31d
Cleared Dec 05, 1988
TEMPOROMANDIBULAR JOINT COIL (TMJ)
K884743 · LNH
Diasonics, Inc.
Radiology · 21d
Cleared Dec 01, 1988
ACUSON L538 TRANSDUCER
K883752 · IYO
Acuson Corp.
Radiology · 90d
Cleared Nov 30, 1988
GE MR MAX SYSTEM
K883547 · LNH
General Electric Co.
Radiology · 103d
Cleared Nov 30, 1988
SONY CINE VIDEO SYSTEM SME-3300
K884008 · IZI
Sony Medical Electronics Co.
Radiology · 70d
Cleared Nov 30, 1988
SHOULDER TRANSMIT AND RECEIVE COILS
K884603 · LNH
Diasonics, Inc.
Radiology · 27d
Cleared Nov 30, 1988
MT/S CARLSON SPINE COIL, PART # 100-50082500-01
K884604 · LNH
Diasonics, Inc.
Radiology · 27d
Cleared Nov 29, 1988
ULTRAMARK 4+ ULTRASOUND W/3.5 MHZ 40R CONVEX ARRAY
K881140 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 257d
Cleared Nov 29, 1988
MODEL 500V VASCULAR SPECTRUM ANALYZER
K882755 · IYN
Multigon Industries, Inc.
Radiology · 147d
Cleared Nov 28, 1988
POSTERIOR CERVICAL SPINE SURFACE COIL M1085AM
K884369 · LNH
General Electric Co.
Radiology · 41d
Cleared Nov 25, 1988
ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT
K883372 · JAA
Ausonics Pty , Ltd.
Radiology · 107d
Cleared Nov 23, 1988
POLYSCAN DIGITAL SCANNER
K882453 · IYW
Medical and Scientific Enterprises, Inc.
Radiology · 162d
Cleared Nov 23, 1988
VOXEL FLINGER(TM) 3-D IMAGING SYSTEM
K883476 · LLZ
Reality Imaging Corp.
Radiology · 99d
Cleared Nov 23, 1988
MAGNETOM (M, H, 42, 63) SEQUENCES
K884062 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 58d
Cleared Nov 23, 1988
DISKCAM DC 6001
K884148 · LMB
Camtronics, Ltd.
Radiology · 51d
Cleared Nov 21, 1988
IMAGER
K883831 · IZI
Fischer Imaging Corp.
Radiology · 73d
Cleared Nov 21, 1988
ADVANTAGE
K883860 · IZI
Fischer Imaging Corp.
Radiology · 69d
Cleared Nov 21, 1988
CP HEAD COIL & 260MM (CV) TRANSMIT-RECEIVE COIL
K883872 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 69d