510k
Database
Specialties
Anesthesiology
479
Cardiovascular
1444
Chemistry
337
Dental
1140
Ear, Nose, Throat
210
Gastroenterology & Urology
841
General & Plastic Surgery
1897
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1441
Hematology
125
Immunology
89
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8
Microbiology
426
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812
Obstetrics & Gynecology
362
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238
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2484
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49
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439
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2065
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145
Categories
GEX
Powered Laser Surgical Instrument
307
LLZ
System, Image Processing,...
305
LZA
Polymer Patient Examination Glove
278
GEI
Electrosurgical, Cutting &...
261
QIH
Automated Radiological Image...
256
IYN
System, Imaging, Pulsed Doppler,...
246
HRS
Plate, Fixation, Bone
245
OLO
Orthopedic Stereotaxic Instrument
204
NHA
Abutment, Implant, Dental,...
191
MAX
Intervertebral Fusion Device...
172
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Porta Ray, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Porta Ray, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1980
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Porta Ray, Inc.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Dec 15, 1986
PORTA RAY MODEL 325
K864339
·
IZO
Radiology
·
41d
Cleared
May 21, 1981
BETA I & BETA II
K811082
·
IZL
Radiology
·
30d
Cleared
Mar 11, 1981
ALPHA I AND ALPHA II
K810276
·
IZL
Radiology
·
37d
Cleared
Jan 29, 1980
PIXIE
K792665
·
IZL
Radiology
·
33d
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4
Radiology
4