510k
Database
Specialties
Anesthesiology
456
Cardiovascular
1389
Chemistry
334
Dental
1080
Ear, Nose, Throat
198
Gastroenterology & Urology
824
General & Plastic Surgery
1821
General Hospital
1271
Hematology
124
Immunology
85
Medical Genetics
7
Microbiology
420
Neurology
778
Obstetrics & Gynecology
345
Ophthalmic
218
Orthopedic
2439
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
240
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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Image Diagnostics, Inc.
Medical Device Manufacturer
·
US , Sterling , MA
Image Diagnostics, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1994
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Image Diagnostics, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 24, 1995
ID400 SERIES ARMBOARDS
K950631
·
JAA
Radiology
·
39d
Cleared
Oct 20, 1994
MULTIPLE ED1600 SERIES RADIATION SHIELDS
K944772
·
EAK
Radiology
·
23d
Cleared
Aug 17, 1994
ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE
K942190
·
IXQ
Radiology
·
105d
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3
Radiology
3