510k
Database
Specialties
Anesthesiology
429
Cardiovascular
1299
Chemistry
327
Dental
1001
Ear, Nose, Throat
187
Gastroenterology & Urology
773
General & Plastic Surgery
1688
General Hospital
1094
Hematology
117
Immunology
83
Medical Genetics
7
Microbiology
411
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730
Obstetrics & Gynecology
318
Ophthalmic
198
Orthopedic
2356
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44
Physical Medicine
393
Radiology
1888
Toxicology
140
Categories
GEX
Powered Laser Surgical Instrument
279
LLZ
System, Image Processing,...
266
QIH
Automated Radiological Image...
246
GEI
Electrosurgical, Cutting &...
238
HRS
Plate, Fixation, Bone
231
IYN
System, Imaging, Pulsed Doppler,...
231
OLO
Orthopedic Stereotaxic Instrument
193
NHA
Abutment, Implant, Dental,...
180
LZA
Polymer Patient Examination Glove
170
NKB
Thoracolumbosacral Pedicle Screw...
161
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Algotec Systems, Ltd.
Medical Device Manufacturer
·
IL , Efrat
Algotec Systems, Ltd. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1996
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Algotec Systems, Ltd.
Radiology
✕
5
devices
1-5 of 5
Filters
Cleared
Nov 25, 2003
MDIFICATION TO MEDIPRIME
K033013
·
LLZ
Radiology
·
60d
Cleared
Dec 20, 2002
MODIFICATION TO MEDIPRIME
K023936
·
LLZ
Radiology
·
24d
Cleared
Dec 05, 2000
MEDIPRIME
K002894
·
LLZ
Radiology
·
78d
Cleared
Jul 20, 1998
PRO VISION
K980648
·
LLZ
Radiology
·
151d
Cleared
Jan 05, 1996
PRO VISION
K954678
·
LLZ
Radiology
·
87d
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5
Radiology
5