FDA Review Panel · RA

FDA 510(k) Radiology Devices

FDA 510(k) Radiology Devices - Regulatory Overview

FDA 510(k) radiology devices include medical imaging systems and radiation therapy equipment. The FDA review panel code is RA.

Key modalities covered:

  • X-ray and fluoroscopy - digital radiography, fluoroscopy systems and C-arms
  • Computed tomography (CT) - whole-body and dedicated CT scanners
  • Magnetic resonance imaging (MRI) - 1.5T, 3T and extremity MRI systems
  • Ultrasound imaging - diagnostic, point-of-care and intravascular ultrasound
  • Radiation therapy - linear accelerators, brachytherapy and treatment planning
  • Nuclear medicine - PET, SPECT and gamma camera systems

15620
Total
15601
Cleared
148d
Avg (2y)
1976
Since
12795 Radiology devices
9001–9025 of 12795
Cleared Oct 10, 2000
LIGTHSPEED 3.0 CT SCANNER SYSTEM
K002978 · GE Medical Systems
JAK · System, X-ray, Tomography, Computed · 15d
Cleared Sep 28, 2000
MEDLINK DIAGNOSTIC OFFLINE WORKSTATION
K002144 · Advanced Technology Laboratories, Inc.
LLZ · System, Image Processing, Radiological · 73d
Cleared Sep 28, 2000
HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER
K002711 · Hologic, Inc.
KGI · Densitometer, Bone · 28d
Cleared Sep 27, 2000
ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART
K002039 · Cti Pet Systems, Inc.
LLZ · System, Image Processing, Radiological · 84d
Cleared Sep 27, 2000
KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY
K002146 · Eastman Kodak Company
LMC · Camera, Multi Format, Radiological · 72d
Cleared Sep 20, 2000
ALOKA UST-5280-5
K002784 · Aloka Co., Ltd.
ITX · Transducer, Ultrasonic, Diagnostic · 14d
Cleared Sep 08, 2000
M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER
K002470 · Agilent Technologies, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 28d
Cleared Sep 07, 2000
LOOK COLLAGEN SPACERS, MODEL 1514B
K001765 · Surgical Specialties Corp
KXK · Source, Brachytherapy, Radionuclide · 87d
Cleared Sep 06, 2000
GYROSCAN INTERA (R7.5)
K001796 · Philips Medical Systems North America, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 84d
Cleared Sep 06, 2000
EXPLORER GRADIENT
K001987 · Philips Medical Systems North America, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 69d
Cleared Sep 06, 2000
PHILIPS INTEGRIS ALLURA
K002016 · Philips Medical Systems North America, Inc.
OWB · Interventional Fluoroscopic X-ray System · 65d
Cleared Sep 05, 2000
OBC-63 MEBREAST ARRAY COIL
K002602 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 15d
Cleared Sep 05, 2000
PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM
K993675 · Nomos Corp.
MUJ · System, Planning, Radiation Therapy Treatment · 309d
Cleared Sep 05, 2000
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT
K994103 · Olympus America, Inc.
ITX · Transducer, Ultrasonic, Diagnostic · 274d
Cleared Aug 30, 2000
NEUROVASCULAR ARRAY COIL
K001946 · Ge Medical Systems, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 65d
Cleared Aug 30, 2000
PROTON VISION 7.0
K002312 · Varian Medical Systems, Inc.
MUJ · System, Planning, Radiation Therapy Treatment · 30d
Cleared Aug 30, 2000
OBC-096 BREAST ARRAY COIL
K002539 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 14d
Cleared Aug 30, 2000
MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM
K994283 · Medis Medical Imaging Systems BV
LNH · System, Nuclear Magnetic Resonance Imaging · 254d
Cleared Aug 25, 2000
COMBISON 301 PW ULTRASOUND SYSTEM AND TRANSDUCERS
K002491 · Medison Co., Ltd.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 11d
Cleared Aug 18, 2000
TREATVISION
K002194 · Varian Medical Systems, Inc.
LHN · System, Radiation Therapy, Charged-particle, Medical · 29d
Cleared Aug 18, 2000
POWERDRIVE 350 OPTION
K002415 · Philips Medical Systems (Cleveland), Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 10d
Cleared Aug 17, 2000
M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER
K002397 · Agilent Technologies, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 10d
Cleared Aug 14, 2000
MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COIL
K001870 · Usa Instruments, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 55d
Cleared Aug 14, 2000
HAC-300 HEAD ARRAY COIL
K001944 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 49d
Cleared Aug 08, 2000
OR TABLE/MAGNETOM OPEN VIVA SYSTEM
K002225 · Siemens Medical Solutions USA, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 15d

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All categories 12795 LLZ System, Image Processing, Radiological 2033 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1126 LNH System, Nuclear Magnetic Resonance Imaging 997 JAK System, X-ray, Tomography, Computed 747 IYO System, Imaging, Pulsed Echo, Ultrasonic 683 IYE Accelerator, Linear, Medical 583 MOS Coil, Magnetic Resonance, Specialty 456 MQB Solid State X-ray Imager (flat Panel/digital Imager) 411 KPS System, Tomography, Computed, Emission 387 ITX Transducer, Ultrasonic, Diagnostic 347 QIH Automated Radiological Image Processing Software 320 OWB Interventional Fluoroscopic X-ray System 313 KPR System, X-ray, Stationary 292 MUJ System, Planning, Radiation Therapy Treatment 236 MUH System, X-ray, Extraoral Source, Digital 192