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
9145–9168 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 31, 2001
OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS
K012495 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Oct 31, 2001
MODIFICATION TO: ECAT LSO PET/CT SCANNER
K013504 · KPS
Cti Pet Systems, Inc.
Radiology · 9d
Cleared Oct 30, 2001
ULTRASOUND TRANSDUCER COVER
K011265 · ITX
Advance Medical Designs, Inc.
Radiology · 188d
Cleared Oct 30, 2001
LIFEJET VIDEO LINK
K013395 · LMA
Ferrania S.P.A.
Radiology · 15d
Cleared Oct 30, 2001
CARDIQ FUNCTION
K013422 · JAK
GE Medical Systems
Radiology · 15d
Cleared Oct 26, 2001
ADVANCED LUNG ANALYSIS-1
K013381 · JAK
General Electric Co.
Radiology · 14d
Cleared Oct 24, 2001
CAAS II QVA
K012475 · LLZ
Pie Medical Imaging BV
Radiology · 83d
Cleared Oct 24, 2001
MACHNET CAROTIDS COIL ARRAY ASSEMBLY
K012491 · MOS
Machnet BV
Radiology · 82d
Cleared Oct 24, 2001
MODIFIED 650 MAMMOGRAPHY SYSTEM
K013290 · IZH
Lorad, A Hologic Co.
Radiology · 22d
Cleared Oct 18, 2001
ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS
K002132 · MUJ
Intelligent Instruments Pvt. , Ltd.
Radiology · 461d
Cleared Oct 18, 2001
SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM
K012424 · JAA
Shimadzu Corp.
Radiology · 80d
Cleared Oct 18, 2001
WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL
K012522 · ITX
National Therapy Products, Inc.
Radiology · 73d
Cleared Oct 18, 2001
MR-GUIDE 2000
K013150 · LNH
Ultraguide , Ltd.
Radiology · 28d
Cleared Oct 18, 2001
MOSFET AUTOSENSE, MODEL TN-RD-60
K013279 · IYE
Thomson & Nielsen Electronics, Ltd.
Radiology · 16d
Cleared Oct 17, 2001
SEED SELECTRON MODEL V. 1.0
K010032 · JAQ
Nucletron Corp.
Radiology · 287d
Cleared Oct 16, 2001
HRH-63-8 HEAD ARRAY COIL
K013159 · MOS
Mri Devices Corp.
Radiology · 25d
Cleared Oct 16, 2001
MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE
K013176 · EHD
Afp Imaging Corp.
Radiology · 22d
Cleared Oct 16, 2001
HAC-420 HEAD ARRAY COIL
K013322 · MOS
Mri Devices Corp.
Radiology · 11d
Cleared Oct 12, 2001
LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE
K013229 · IXA
Ferrania USA, Inc.
Radiology · 15d
Cleared Oct 05, 2001
DIASUS
K013142 · IYO
Dynamic Imaging , Ltd.
Radiology · 15d
Cleared Oct 05, 2001
CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A
K013214 · JAK
Toshiba America Medical Systems, In.C
Radiology · 9d
Cleared Oct 01, 2001
SOLID STATE X-RAY IMAGING DEVICES
K003238 · MQB
Cares Built, Inc.
Radiology · 349d
Cleared Oct 01, 2001
EXPRESSSUITE
K011049 · LMA
Vidar Systems Corp.
Radiology · 178d
Cleared Oct 01, 2001
MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1
K012227 · IYE
Oncology Data Systems, Inc.
Radiology · 77d