510k
Database
Specialties
Anesthesiology
452
Cardiovascular
1374
Chemistry
334
Dental
1066
Ear, Nose, Throat
196
Gastroenterology & Urology
815
General & Plastic Surgery
1797
General Hospital
1230
Hematology
121
Immunology
85
Medical Genetics
7
Microbiology
420
Neurology
769
Obstetrics & Gynecology
339
Ophthalmic
215
Orthopedic
2429
Pathology
44
Physical Medicine
412
Radiology
1987
Toxicology
143
Categories
GEX
Powered Laser Surgical Instrument
294
LLZ
System, Image Processing,...
285
GEI
Electrosurgical, Cutting &...
254
QIH
Automated Radiological Image...
252
IYN
System, Imaging, Pulsed Doppler,...
242
HRS
Plate, Fixation, Bone
236
LZA
Polymer Patient Examination Glove
207
OLO
Orthopedic Stereotaxic Instrument
199
NHA
Abutment, Implant, Dental,...
187
MAX
Intervertebral Fusion Device...
168
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New Image Industries, Inc.
Medical Device Manufacturer
·
US , Newport Beach , CA
New Image Industries, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1994
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - New Image Industries, Inc.
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 10, 1994
MICRODONTIC LENS
K941716
·
EIA
Dental
·
125d
Cleared
Feb 04, 1994
PERIO/ENDO LENS
K934002
·
EIA
Dental
·
172d
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3
Dental
2
Radiology
1