510k
Database
Specialties
Anesthesiology
430
Cardiovascular
1306
Chemistry
327
Dental
1004
Ear, Nose, Throat
190
Gastroenterology & Urology
781
General & Plastic Surgery
1697
General Hospital
1101
Hematology
117
Immunology
83
Medical Genetics
7
Microbiology
412
Neurology
732
Obstetrics & Gynecology
321
Ophthalmic
199
Orthopedic
2365
Pathology
44
Physical Medicine
393
Radiology
1898
Toxicology
140
Categories
GEX
Powered Laser Surgical Instrument
281
LLZ
System, Image Processing,...
267
QIH
Automated Radiological Image...
246
GEI
Electrosurgical, Cutting &...
239
IYN
System, Imaging, Pulsed Doppler,...
232
HRS
Plate, Fixation, Bone
231
OLO
Orthopedic Stereotaxic Instrument
194
NHA
Abutment, Implant, Dental,...
180
LZA
Polymer Patient Examination Glove
170
NKB
Thoracolumbosacral Pedicle Screw...
161
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Ophthalmic Technologies, Inc.
Medical Device Manufacturer
·
CA , Downsview, Ontario
Ophthalmic Technologies, Inc. - FDA 510(k) Cleared Devices
9 submissions
·
8 cleared
·
Since 1995
9
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ophthalmic Technologies, Inc.
Radiology
✕
5
devices
1-5 of 5
Filters
Cleared
Jun 20, 2003
HF MODULE WITH TRANSDUCERS
K031391
·
IYO
Radiology
·
49d
Cleared
Mar 27, 2003
OTI SCAN WITH TRANSDUCERS
K030770
·
IYO
Radiology
·
16d
Cleared
Jan 10, 2003
A-SCAN 100
K024114
·
IYO
Radiology
·
28d
Cleared
Feb 25, 1998
3D I-SCAN
K974522
·
IYO
Radiology
·
85d
Cleared
May 13, 1996
I-SCAN
K960622
·
IYO
Radiology
·
90d
Filters
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9
Radiology
5
Ophthalmic
3
General & Plastic Surgery
1