510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1672
Chemistry
362
Dental
1335
Ear, Nose, Throat
245
Gastroenterology & Urology
964
General & Plastic Surgery
2190
General Hospital
2043
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2900
Pathology
52
Physical Medicine
515
Radiology
2433
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
386
FXX
Mask, Surgical
358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
270
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
219
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Infrascan, Inc.
Medical Device Manufacturer
·
US , Philadelphia , PA
Infrascan, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
4 cleared
·
Since 2011
5
Total
4
Cleared
1
Denied
FDA 510(k) Regulatory Record - Infrascan, Inc.
Neurology
✕
5
devices
1-5 of 5
Filters
Cleared
Dec 12, 2024
Infrascanner Model 2500 (Model 2500)
K241389
·
OPT
Neurology
·
211d
Cleared
Feb 09, 2022
Infrascanner
K211617
·
OPT
Neurology
·
259d
Cleared
Jul 10, 2020
Infrascanner
K200203
·
OPT
Neurology
·
164d
Cleared
Jan 11, 2013
INFRASCANNER
K120949
·
OPT
Neurology
·
287d
Not Cleared
Dec 13, 2011
INFRASCANNER, MODEL 1000
DEN100002
·
OPT
Neurology
·
614d
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5
Neurology
5