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
10345–10368 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 22, 1997
ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL
K974423 · EAM
Sterling Diagnostic Imaging, Inc.
Radiology · 28d
Cleared Dec 18, 1997
DIGITAL ADD ON MULTI SYSTEM
K973710 · KPR
Swissray International, Inc.
Radiology · 80d
Cleared Dec 17, 1997
KNOLL/MIDUS (MALE IMPOTENCE DIAGNOSTIC ULTRASONIC SYSTEM)
K971790 · IYN
Urometrics, Inc.
Radiology · 217d
Cleared Dec 17, 1997
PERCEPTION INC. GPS-XYZ DIAGNOSTIC ULTRASOUND SYSTEM
K972192 · IYO
Perception, Inc.
Radiology · 190d
Cleared Dec 17, 1997
ELEKTA ONCOLOGY SYSTEMS ICOM/QUICKMODE SOFTWARE OPTIONS
K973540 · IYE
Elekta Oncology Systems, Inc.
Radiology · 90d
Cleared Dec 17, 1997
OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE
K973793 · LMD
Olicon Imaging Systems, Inc.
Radiology · 72d
Cleared Dec 12, 1997
ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY)
K971528 · IYO
Fujinon, Inc.
Radiology · 228d
Cleared Dec 12, 1997
COMPACT OR COMP-X
K972365 · IZL
Eurotec, S.R.L.
Radiology · 170d
Cleared Dec 12, 1997
SEEMOR - DISPLAY & PROCESSING PROGRAM EXECUTING ON PERSONAL COMPUTER SYSTEM
K973653 · LLZ
Areeda Assoc., Ltd.
Radiology · 78d
Cleared Dec 12, 1997
MINXRAY HF100H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT
K973712 · IZL
Minxray, Inc.
Radiology · 74d
Cleared Dec 12, 1997
SMART MOTORIZED VIEWER
K973965 · IXC
Smartlight, Ltd.
Radiology · 56d
Cleared Dec 05, 1997
ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION...
K972925 · LMD
Access Radiology Corp.
Radiology · 119d
Cleared Dec 05, 1997
IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR...
K973421 · LMD
Dejarnette Research Systems
Radiology · 86d
Cleared Dec 05, 1997
CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM
K973630 · MOS
Siemens Medical Solutions USA, Inc.
Radiology · 72d
Cleared Dec 05, 1997
CARBON FIBER CONFORMAL COUCH TOP
K973842 · IXQ
Medtec, Inc.
Radiology · 58d
Cleared Dec 04, 1997
AUTIMO 2.5-D AND AUTIMO 3-D
K972016 · IXI
C.L. Mcintosh & Assoc., Inc.
Radiology · 188d
Cleared Dec 04, 1997
STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY
K973206 · MQB
Sterling Diagnostic Imaging, Inc.
Radiology · 100d
Cleared Dec 04, 1997
DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)
K973411 · LMA
General Scanning, Inc.
Radiology · 86d
Cleared Dec 02, 1997
ACCUDEXA BONE DENSITOMETER
K971735 · KGI
Schick Technologies, Inc.
Radiology · 204d
Cleared Dec 02, 1997
THERAPAX DXT 300 MODEL HF-300
K973315 · JAD
Pantak, Inc.
Radiology · 90d
Cleared Dec 02, 1997
OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE
K973463 · LMB
O Tech, Inc.
Radiology · 81d
Cleared Nov 26, 1997
DICOM 3.0 SOFTWARE VERSION 2.0
K973239 · LMD
Adac Laboratories
Radiology · 90d
Cleared Nov 26, 1997
TRANSDUCER POSITIONER
K973622 · ITX
Protek Medical Products, Inc.
Radiology · 64d
Cleared Nov 25, 1997
IMAGE FUSION AND REVIEW SYSTEM
K973233 · KPS
Adac Laboratories
Radiology · 89d