510k
Database
Specialties
Anesthesiology
456
Cardiovascular
1389
Chemistry
334
Dental
1080
Ear, Nose, Throat
198
Gastroenterology & Urology
824
General & Plastic Surgery
1821
General Hospital
1267
Hematology
124
Immunology
85
Medical Genetics
7
Microbiology
420
Neurology
778
Obstetrics & Gynecology
345
Ophthalmic
218
Orthopedic
2436
Pathology
46
Physical Medicine
416
Radiology
2008
Toxicology
143
Categories
GEX
Powered Laser Surgical Instrument
298
LLZ
System, Image Processing,...
291
GEI
Electrosurgical, Cutting &...
256
QIH
Automated Radiological Image...
253
IYN
System, Imaging, Pulsed Doppler,...
242
HRS
Plate, Fixation, Bone
237
LZA
Polymer Patient Examination Glove
217
OLO
Orthopedic Stereotaxic Instrument
199
NHA
Abutment, Implant, Dental,...
189
MAX
Intervertebral Fusion Device...
169
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Ohio Imaging, Inc.
Medical Device Manufacturer
·
US , Cleveland , OH
Ohio Imaging, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1988
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ohio Imaging, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 21, 1995
PRISM 1500XP NUCLEAR GAMMA CAMERA SYSTEM
K945261
·
KPS
Radiology
·
144d
Cleared
May 13, 1994
PRISM 3000 NUCLEAR GAMMA CAMERA SYSTEM MODIFICATION
K934722
·
KPS
Radiology
·
226d
Cleared
Jul 14, 1988
MODEL 3000 NUCLEAR CAMERA
K882312
·
IYX
Radiology
·
41d
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3
Radiology
3