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
9457–9480 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 24, 2000
RADIOMED SOURCE
K001070 · KXK
Radiomed Corp.
Radiology · 204d
Cleared Oct 24, 2000
SOMATOM SMILE
K003152 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Oct 23, 2000
DMLC IV-ERGO
K001163 · IXI
3D Line USA, Inc.
Radiology · 196d
Cleared Oct 23, 2000
RE-ENTRANT CHAMBER, MODEL 1008 OR 44D
K002446 · KXK
Sun Nuclear Corp.
Radiology · 75d
Cleared Oct 23, 2000
X-POSURE SYSTEM VERSION 2 RAD
K002500 · KGI
Pronosco A/S
Radiology · 70d
Cleared Oct 20, 2000
RADIOCAMERAS EXTRACRANIAL SYSTEM
K000246 · IYE
Surgical Navigation Technologies, Inc.
Radiology · 267d
Cleared Oct 20, 2000
WACKERS-LIU CQ SOFTWARE
K002229 · KPS
Eclipse Systems, Inc.
Radiology · 88d
Cleared Oct 20, 2000
MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS
K003121 · IYO
Medison America, Inc.
Radiology · 15d
Cleared Oct 20, 2000
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
K003125 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Oct 19, 2000
VITREA 2, VERSION 2.1
K002519 · LLZ
Vital Images, Inc.
Radiology · 65d
Cleared Oct 18, 2000
PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206
K002444 · IYE
Sun Nuclear Corp.
Radiology · 70d
Cleared Oct 17, 2000
FLUOROSCAN PROFILE, MODEL TCA 4 PLUS
K002198 · OWB
Fluoro Scan Imaging Systems, Inc.
Radiology · 89d
Cleared Oct 17, 2000
HITACHI ALTAIRE
K002420 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 70d
Cleared Oct 17, 2000
VISION 9000 PHASED ARRAY TORSO COIL
K002482 · MOS
Usa Instruments, Inc.
Radiology · 64d
Cleared Oct 17, 2000
MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM
K002936 · LLZ
Sectra-Imtec AB
Radiology · 26d
Cleared Oct 13, 2000
FOCUS
K002147 · MUJ
Computerized Medical Systems, Inc.
Radiology · 88d
Cleared Oct 12, 2000
SOMATOM EMOTION MS
K003014 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Oct 11, 2000
MAGNETOM ALLEGRA SYSTEM
K002179 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Oct 11, 2000
SURGI-VISION URETHRAL COIL
K002345 · MOS
Surgi-Vision, Inc.
Radiology · 70d
Cleared Oct 10, 2000
LIGTHSPEED 3.0 CT SCANNER SYSTEM
K002978 · JAK
GE Medical Systems
Radiology · 15d
Cleared Oct 03, 2000
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER
K002490 · LNH
Fonar Corp.
Radiology · 50d
Cleared Sep 28, 2000
PREFERENCE TREATMENT SYSTEM
K001833 · IYE
Northwest Medical Physics Equipment,...
Radiology · 104d
Cleared Sep 28, 2000
MEDLINK DIAGNOSTIC OFFLINE WORKSTATION
K002144 · LLZ
Advanced Technology Laboratories, Inc.
Radiology · 73d
Cleared Sep 28, 2000
HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND...
K002711 · KGI
Hologic, Inc.
Radiology · 28d