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
15668
Total
15649
Cleared
148d
Avg (2y)
1976
Since
12997 Radiology devices
Cleared
Feb 28, 1977
RADIONUCLIDE COMPUTED TOMOGRAPHY SYS.
KPS
System, Tomography, Computed, Emission
25d
Cleared
Feb 28, 1977
MAXICAMERA II
IYX
Camera, Scintillation (gamma)
10d
Cleared
Feb 07, 1977
CTM (CLINAC TREATMENT MONITOR)
KPQ
System, Simulation, Radiation Therapy
7d
Cleared
Jan 21, 1977
FLUORICON 500 IMAGE INTENSIFIERS
EAM
Screen, Intensifying, Radiographic
4d
Cleared
Jan 18, 1977
MPX 80
IZO
Generator, High-voltage, X-ray, Diagnostic
15d
Cleared
Jan 18, 1977
MPX 100
IZO
Generator, High-voltage, X-ray, Diagnostic
15d
Cleared
Jan 18, 1977
MPX 125
IZO
Generator, High-voltage, X-ray, Diagnostic
15d
Cleared
Jan 05, 1977
RADIAL TRAVEL SPEC. PROCEDURES TABLE
IZZ
Table, Radiographic, Non-tilting, Powered
9d
Cleared
Dec 21, 1976
VARIPLAN COMPUT. RADIOTHERAPY
KPQ
System, Simulation, Radiation Therapy
5d
Cleared
Dec 16, 1976
RADIOISOTOPE CALIBRATOR (CRCO-22NB)
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
20d
Cleared
Dec 16, 1976
WELL COUNTERS, LOGIC II (200 SERIES)
JJJ
Counter (beta, Gamma) For Clinical Use
9d
Cleared
Dec 06, 1976
PORTACAMERA 11-B
IYX
Camera, Scintillation (gamma)
7d
Cleared
Nov 19, 1976
SUPERMAX AUTOMATIC X-RAY PROCESSOR
IXW
Processor, Radiographic-film, Automatic
24d
Cleared
Nov 19, 1976
THERMOGRAPH, MEDICAL
IYM
System, Telethermographic, Infrared
11d
Cleared
Nov 09, 1976
BARIMEX, BARIUM SULFATE COMPOUND
KTA
Medium, Contrast, Radiologic
42d
Cleared
Nov 05, 1976
PHO. TRAX MODEL 4000 WHOLE BODY SCAN.
JAK
System, X-ray, Tomography, Computed
24d
Cleared
Oct 05, 1976
CT/N-II SCANNER SYSTEM
JAK
System, X-ray, Tomography, Computed
15d
Cleared
Oct 05, 1976
PORTABLE X-RAY
IZL
System, X-ray, Mobile
5d
Cleared
Sep 17, 1976
CARDIAC PROBE
IZD
Probe, Uptake, Nuclear
10d
Cleared
Aug 26, 1976
TABLE, X-RAY, RFX CLASSICAL
IXR
Table, Radiographic, Tilting
8d
Cleared
Aug 23, 1976
FLOUROSCOPE, MOBILE C-ARM IMAGE INTENS.
OXO
Image-intensified Fluoroscopic X-ray System, Mobile
10d
Cleared
Aug 13, 1976
X-RAY FILM, CONVEY OR SYSTEM
KPX
Changer, Radiographic Film/cassette
21d
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