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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
9649–9672 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 06, 2000
EXPLORER GRADIENT
K001987 · LNH
Philips Medical Systems North...
Radiology · 69d
Cleared Sep 06, 2000
PHILIPS INTEGRIS ALLURA
K002016 · OWB
Philips Medical Systems North...
Radiology · 65d
Cleared Sep 05, 2000
INVIDOS
K002051 · IYE
Scanditronix Medical AB
Radiology · 61d
Cleared Sep 05, 2000
OBC-63 MEBREAST ARRAY COIL
K002602 · MOS
Mri Devices Corp.
Radiology · 15d
Cleared Sep 05, 2000
PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM
K993675 · MUJ
Nomos Corp.
Radiology · 309d
Cleared Sep 05, 2000
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR...
K994103 · ITX
Olympus America, Inc.
Radiology · 274d
Cleared Sep 01, 2000
STRATO X
K002432 · EHD
Villa Sistemi Medicali S.P.A.
Radiology · 24d
Cleared Aug 30, 2000
MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX
K001052 · IYE
Med-Tec,Inc.
Radiology · 149d
Cleared Aug 30, 2000
NEUROVASCULAR ARRAY COIL
K001946 · MOS
Ge Medical Systems, Inc.
Radiology · 65d
Cleared Aug 30, 2000
PROTON VISION 7.0
K002312 · MUJ
Varian Medical Systems, Inc.
Radiology · 30d
Cleared Aug 30, 2000
MICRO-MAX, MODEL 319
K002404 · IXW
Tek Marketing, Inc.
Radiology · 23d
Cleared Aug 30, 2000
TCD 100M, PWD13 TRANSDUCER
K002533 · IYN
Spencer Technologies
Radiology · 14d
Cleared Aug 30, 2000
OBC-096 BREAST ARRAY COIL
K002539 · MOS
Mri Devices Corp.
Radiology · 14d
Cleared Aug 30, 2000
MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM
K994283 · LNH
Medis Medical Imaging Systems BV
Radiology · 254d
Cleared Aug 25, 2000
POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM
K001681 · KPS
Smv America
Radiology · 85d
Cleared Aug 25, 2000
XIMX SYSTEM
K002100 · LLZ
Medical Manager Research Development
Radiology · 45d
Cleared Aug 25, 2000
COMBISON 301 PW ULTRASOUND SYSTEM AND TRANSDUCERS
K002491 · IYN
Medison Co., Ltd.
Radiology · 11d
Cleared Aug 23, 2000
RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0
K002240 · MUJ
Precision Therapy Intl., Inc.
Radiology · 30d
Cleared Aug 22, 2000
BRACHYSEED
K000475 · KXK
Draximage, Inc.
Radiology · 189d
Cleared Aug 18, 2000
DOSE 1
K000209 · IYE
Scanditronix Wellhofer North America
Radiology · 207d
Cleared Aug 18, 2000
ORTHONE
K001773 · LNH
Oni, Inc.
Radiology · 67d
Cleared Aug 18, 2000
TREATVISION
K002194 · LHN
Varian Medical Systems, Inc.
Radiology · 29d
Cleared Aug 18, 2000
POWERDRIVE 350 OPTION
K002415 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 10d
Cleared Aug 17, 2000
M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER
K002397 · IYN
Agilent Technologies, Inc.
Radiology · 10d