510k
Database
Specialties
Anesthesiology
374
Cardiovascular
1179
Chemistry
288
Dental
874
Ear, Nose, Throat
161
Gastroenterology & Urology
689
General & Plastic Surgery
1478
General Hospital
870
Hematology
108
Immunology
77
Medical Genetics
1
Microbiology
385
Neurology
644
Obstetrics & Gynecology
269
Ophthalmic
171
Orthopedic
2171
Pathology
41
Physical Medicine
350
Radiology
1718
Toxicology
135
Categories
GEX
Powered Laser Surgical Instrument
250
QIH
Automated Radiological Image...
226
IYN
System, Imaging, Pulsed Doppler,...
221
LLZ
System, Image Processing,...
221
HRS
Plate, Fixation, Bone
216
GEI
Electrosurgical, Cutting &...
207
OLO
Orthopedic Stereotaxic Instrument
180
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
147
MAX
Intervertebral Fusion Device...
146
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Agfa Healthcare N.V.
Medical Device Manufacturer
·
BE , Mortsel
Agfa Healthcare N.V. - FDA 510(k) Cleared Devices
27 submissions
·
27 cleared
·
Since 2009
27
Total
27
Cleared
0
Denied
27
devices
26-27 of 27
Filters
1
2
Cleared
Aug 11, 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS
K092238
·
MQB
Radiology
·
19d
Cleared
May 18, 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS
K090672
·
MQB
Radiology
·
66d
1
2
Filters
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27
Radiology
26
General & Plastic Surgery
1