FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,488 results
10321–10344 of 15,488
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 10, 1998
CARBON FIBER BREAST BOARD
K974703 · IYE
Medtec, Inc.
Radiology · 84d
Cleared Mar 10, 1998
OUTLOOK SYSTEM ENHANCEMENT PACKAGE
K974844 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 76d
Cleared Mar 09, 1998
ADC COMPACT (AGFA DIAGNOSTIC CENTER)
K974597 · KPR
Bayer Corp., Agfa Div.
Radiology · 90d
Cleared Mar 04, 1998
SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM
K973802 · IYO
Shimadzu Medical Systems
Radiology · 149d
Cleared Mar 04, 1998
GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA...
K974614 · LNH
Elscint, Inc.
Radiology · 83d
Cleared Mar 04, 1998
MATRIX MT-MX3
K974700 · IYE
Medtec, Inc.
Radiology · 78d
Cleared Mar 04, 1998
DYNA VUE 3-D IMAGING PRODUCT
K974755 · LLZ
Imd Systems, Inc.
Radiology · 75d
Cleared Feb 27, 1998
EPS
K974504 · LLZ
E For M Imaging Systems Div.,...
Radiology · 88d
Cleared Feb 26, 1998
STRATIS II
K974498 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 90d
Cleared Feb 25, 1998
ECAT PET SCANNERS
K974256 · KPS
Cti Pet Systems, Inc.
Radiology · 104d
Cleared Feb 25, 1998
3D I-SCAN
K974522 · IYO
Ophthalmic Technologies, Inc.
Radiology · 85d
Cleared Feb 25, 1998
SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM
K974619 · LMA
Afp Imaging Corp.
Radiology · 76d
Cleared Feb 25, 1998
ECHOLINK
K980060 · LLZ
Mpacs, LLC
Radiology · 49d
Cleared Feb 24, 1998
DYNEMO 3000
K972798 · DPW
Sometec, Inc.
Radiology · 211d
Cleared Feb 24, 1998
PEGASYS INTOUCH
K974474 · LLZ
Adac Laboratories
Radiology · 90d
Cleared Feb 20, 1998
ANATOM 1000 (A MINUS, A-)
K974455 · JAK
Analogic Corp.
Radiology · 87d
Cleared Feb 17, 1998
REGANES RADIONUCLIDE SEED MAGAZINE
K972554 · IWJ
Avid N.I.T., Inc.
Radiology · 224d
Cleared Feb 17, 1998
INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)
K974355 · OWB
Ge Dec Medical Systems
Radiology · 90d
Cleared Feb 13, 1998
NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS
K973459 · KGI
Norland Corp.
Radiology · 154d
Cleared Feb 13, 1998
RTR-2000/RTR-4000
K974307 · JAK
Terarecon,Inc.
Radiology · 88d
Cleared Feb 13, 1998
ADVANTX LCN, ADVANTX LCLP
K974367 · IZI
GE Medical Systems
Radiology · 85d
Cleared Feb 13, 1998
EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE
K974437 · KGI
Lunar Corp.
Radiology · 81d
Cleared Feb 13, 1998
NUMASTATION
K974444 · KPS
Numa, Inc.
Radiology · 80d
Cleared Feb 13, 1998
IISYS PACS SYSTEM
K980220 · LMD
Sterling Diagnostic Imaging, Inc.
Radiology · 22d