FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
10417–10440 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 30, 1998
CS2000 & CS2000 TOMO
K973834 · IZF
Pausch Corp.
Radiology · 204d
Cleared Apr 30, 1998
MEDRAD ATD-T INTERFACE DEVICE
K974438 · MOS
Medrad, Inc.
Radiology · 157d
Cleared Apr 30, 1998
CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY...
K981280 · IXW
Bayer Corp., Agfa Div.
Radiology · 22d
Cleared Apr 24, 1998
IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000
K973556 · IYN
Imex Medical Systems, Inc.
Radiology · 217d
Cleared Apr 24, 1998
ACCENT 16, ACCENT 22
K980322 · OXO
GE Medical Systems
Radiology · 87d
Cleared Apr 24, 1998
CAPINTEC MODEL 292 ELECTROMETER
K980402 · IYE
Capintec, Inc.
Radiology · 81d
Cleared Apr 24, 1998
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL...
K980557 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 70d
Cleared Apr 22, 1998
GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028
K980851 · IYO
Boston Scientific Corp
Radiology · 48d
Cleared Apr 17, 1998
SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM
K964001 · ITX
Med Institute, Inc.
Radiology · 557d
Cleared Apr 17, 1998
VIDAR VXR LS LASER FILM DIGITIZER
K974315 · LMA
Vidar Systems Corp.
Radiology · 151d
Cleared Apr 17, 1998
OLDELFT DIGIDELCA
K980296 · KPR
Oldelft Corp. of America
Radiology · 80d
Cleared Apr 17, 1998
PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM
K980581 · EHD
Planmeca Oy
Radiology · 59d
Cleared Apr 15, 1998
IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100
K973562 · IYN
Imex Medical Systems, Inc.
Radiology · 208d
Cleared Apr 14, 1998
DENOPTIX BARRIER ENVELOPE (SIZE 0-4)
K980543 · EHD
Dentsply Intl.
Radiology · 61d
Cleared Apr 13, 1998
PREMIER 7000 CTL SPINE COIL
K980157 · MOS
Usa Instruments, Inc.
Radiology · 87d
Cleared Apr 13, 1998
HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS
K980169 · JAK
General Electric Co.
Radiology · 87d
Cleared Apr 13, 1998
HISPEED QX/I CT SCANNER SYSTEM
K980176 · JAK
General Electric Co.
Radiology · 83d
Cleared Apr 09, 1998
LUBRISCAN ULTRA SCAN GEL +, MODEL RG2-60
K980091 · ITX
Cosmaceutical Marketing, Inc.
Radiology · 90d
Cleared Apr 09, 1998
REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR)
K980235 · IZH
Kci New Technologies, Inc.
Radiology · 77d
Cleared Apr 09, 1998
BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY
K980541 · LMD
Barco NV Display Systems
Radiology · 57d
Cleared Apr 03, 1998
PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)
K980243 · LMB
Parameter Developments, Inc.
Radiology · 70d
Cleared Apr 02, 1998
COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE
K980168 · LLZ
Analogic Corp.
Radiology · 76d
Cleared Apr 02, 1998
GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP
K980306 · LNH
Elscint, Inc.
Radiology · 65d
Cleared Apr 02, 1998
HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM
K980860 · IYO
Atlantis Diagnostics Intl., Inc.
Radiology · 28d