510k
Database
Specialties
Anesthesiology
1012
Cardiovascular
4308
Chemistry
3201
Dental
2735
Ear, Nose, Throat
463
Gastroenterology & Urology
2287
General & Plastic Surgery
3848
General Hospital
3545
Hematology
778
Immunology
774
Medical Genetics
15
Microbiology
1404
Neurology
1691
Obstetrics & Gynecology
849
Ophthalmic
492
Orthopedic
7241
Pathology
163
Physical Medicine
958
Radiology
4596
Toxicology
1235
Categories
LLZ
System, Image Processing,...
725
HRS
Plate, Fixation, Bone
671
GEI
Electrosurgical, Cutting &...
539
IYN
System, Imaging, Pulsed Doppler,...
533
GEX
Powered Laser Surgical Instrument
519
LZA
Polymer Patient Examination Glove
489
JWH
Prosthesis, Knee,...
431
MAX
Intervertebral Fusion Device...
403
FXX
Mask, Surgical
400
HWC
Screw, Fixation, Bone
386
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
Home
Manufacturers
US
Ikonisys, Inc.
Medical Device Manufacturer
·
US , New Haven , CT
Ikonisys, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2006
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ikonisys, Inc.
Pathology
✕
1
devices
1-1 of 1
Filters
Cleared
Oct 17, 2008
ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000
K080909
·
NTH
Pathology
·
199d
Filters
Filter by Specialty
All
4
Hematology
3
Pathology
1