510k
Database
Specialties
Anesthesiology
401
Cardiovascular
1214
Chemistry
303
Dental
911
Ear, Nose, Throat
173
Gastroenterology & Urology
717
General & Plastic Surgery
1552
General Hospital
938
Hematology
112
Immunology
79
Medical Genetics
3
Microbiology
395
Neurology
673
Obstetrics & Gynecology
292
Ophthalmic
180
Orthopedic
2202
Pathology
42
Physical Medicine
362
Radiology
1781
Toxicology
137
Categories
GEX
Powered Laser Surgical Instrument
256
LLZ
System, Image Processing,...
239
QIH
Automated Radiological Image...
232
IYN
System, Imaging, Pulsed Doppler,...
222
GEI
Electrosurgical, Cutting &...
218
HRS
Plate, Fixation, Bone
217
OLO
Orthopedic Stereotaxic Instrument
182
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
150
MAX
Intervertebral Fusion Device...
146
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Signostics Pty, Ltd.
Medical Device Manufacturer
·
US , Bainbridge Island , WA
Signostics Pty, Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2009
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Signostics Pty, Ltd.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 03, 2013
SPEQRT ULTRASOUND SYSTEM
K130659
·
IYN
Radiology
·
22d
Cleared
May 07, 2009
SPEQ ULTRASOUND SYSTEM
K090505
·
IYO
Radiology
·
70d
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Radiology
2