510k
Database
Specialties
Anesthesiology
386
Cardiovascular
1201
Chemistry
294
Dental
892
Ear, Nose, Throat
165
Gastroenterology & Urology
708
General & Plastic Surgery
1521
General Hospital
904
Hematology
109
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78
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1
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392
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663
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285
Ophthalmic
176
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2192
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42
Physical Medicine
356
Radiology
1749
Toxicology
137
Categories
GEX
Powered Laser Surgical Instrument
253
QIH
Automated Radiological Image...
231
LLZ
System, Image Processing,...
227
IYN
System, Imaging, Pulsed Doppler,...
221
HRS
Plate, Fixation, Bone
217
GEI
Electrosurgical, Cutting &...
211
OLO
Orthopedic Stereotaxic Instrument
182
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
149
MAX
Intervertebral Fusion Device...
146
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Dr Systems, Inc.
Medical Device Manufacturer
·
US , San Diego , CA
Dr Systems, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2004
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dr Systems, Inc.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 10, 2015
DR Systems Zero Download 3D Viewer (Z3D)
K143318
·
LLZ
Radiology
·
111d
Cleared
Aug 16, 2004
DR SYSTEMS PACS, RELEASE 6.1
K041935
·
LLZ
Radiology
·
28d
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Radiology
2