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

15668

Total

15649

Cleared

148d

Avg (2y)

1976

Since

12988 Radiology devices

12826–12850 of 12988

Cleared Sep 17, 1979

MODEL 1338A CRT DISPLAY

K791343 · Hewlett-Packard Co.

IYO · System, Imaging, Pulsed Echo, Ultrasonic · 68d

Cleared Sep 17, 1979

MODEL 1350 GRAPHICS TRANSLATOR

K791344 · Hewlett-Packard Co.

IYO · System, Imaging, Pulsed Echo, Ultrasonic · 68d

Cleared Sep 04, 1979

KODAK ORTHO M FILM

K791360 · Eastman Kodak Company

IWZ · Film, Radiographic · 42d

Cleared Aug 10, 1979

BRITT LENS COMPUTER

K790694 · Britt Corp., Inc.

IYO · System, Imaging, Pulsed Echo, Ultrasonic · 122d

Cleared Aug 03, 1979

ACTA-SCANNER 0220FS

K791153 · Pfizer, Inc.

JAK · System, X-ray, Tomography, Computed · 45d

Cleared Aug 03, 1979

PFIZER 0200FS LOCALLZER

K791163 · Pfizer, Inc.

JAK · System, X-ray, Tomography, Computed · 39d

Cleared Aug 01, 1979

K790321 · General Electric Co.

IYO · System, Imaging, Pulsed Echo, Ultrasonic · 167d

Cleared Jul 30, 1979

K790975 · Siemens Corp.

JAK · System, X-ray, Tomography, Computed · 68d

Cleared Jul 30, 1979

K791214 · Siemens Corp.

IZO · Generator, High-voltage, X-ray, Diagnostic · 28d

Cleared Jul 24, 1979

BATTERY CHARGER, 171 PACEMAKER

K782162 · Telectronics, Inc.

DXY · Implantable Pacemaker Pulse-generator · 215d

Cleared Jun 27, 1979

RADVIEW IMAGER SYSTEM

K790942 · General Electric Co.

JAK · System, X-ray, Tomography, Computed · 40d

Cleared May 11, 1979

INTRAUTERINE CATHETER TIP

K790678 · Sonicaid, Inc.

KXO · Monitor, Pressure, Intrauterine · 32d

Cleared May 07, 1979

K790783 · Siemens Corp.

KXJ · Table, Radiologic · 14d

Cleared Apr 26, 1979

K790765 · Siemens Corp.

IZF · System, X-ray, Tomographic · 7d

Cleared Apr 23, 1979

K790489 · Philips Medical Systems (Cleveland), Inc.

IYO · System, Imaging, Pulsed Echo, Ultrasonic · 42d

Cleared Apr 23, 1979

KODAK GRAY TONE IMAGING FILM

K790629 · Eastman Kodak Company

IWZ · Film, Radiographic · 25d

Cleared Apr 23, 1979

K790685 · Victoreen, Inc.

KPR · System, X-ray, Stationary · 12d

Cleared Mar 26, 1979

MODU-SET COLLIMOTOR

K790463 · Medtronic Vascular

IYX · Camera, Scintillation (gamma) · 21d

Cleared Mar 22, 1979

K790342 · Siemens Corp.

JAK · System, X-ray, Tomography, Computed · 29d

Cleared Mar 21, 1979

MODEL 8100 PRE-FILLED INTRAUTERINE

K790418 · Ge Medical Systems Information Technologies

KXO · Monitor, Pressure, Intrauterine · 21d

Cleared Mar 08, 1979

IMAGER, PHO/SONIC SERIES 2000

K790285 · G.D. Searle and Co.

IYO · System, Imaging, Pulsed Echo, Ultrasonic · 27d

Cleared Feb 21, 1979

RADIOTHERAPY TREATMENT

K790134 · General Electric Co.

JAK · System, X-ray, Tomography, Computed · 29d

Cleared Feb 16, 1979

MONITOR, OFFICE MODEL 140

K790139 · Ge Medical Systems Information Technologies

HGM · System, Monitoring, Perinatal · 28d

Cleared Feb 12, 1979

OCCULAR COMPU-SCAN

K790023 · Storz Instrument Co.

IYO · System, Imaging, Pulsed Echo, Ultrasonic · 40d

Cleared Feb 02, 1979

K781916 · E-Z-Em, Inc.

KXZ · System, Thermographic, Liquid Crystal, Powered (adjunctive Use) · 80d

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