510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1660
Chemistry
362
Dental
1329
Ear, Nose, Throat
244
Gastroenterology & Urology
957
General & Plastic Surgery
2182
General Hospital
2039
Hematology
126
Immunology
97
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8
Microbiology
464
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962
Obstetrics & Gynecology
433
Ophthalmic
274
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2862
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52
Physical Medicine
515
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2418
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
288
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Skanray Technologies Limited
Medical Device Manufacturer
·
IN , Mysore
Skanray Technologies Limited - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2022
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Skanray Technologies Limited
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Dec 16, 2025
SKAN C PULSAR
K251893
·
OWB
Radiology
·
179d
Cleared
Oct 27, 2023
PodSKAN HF Diagnostic X-ray System
K231761
·
KPR
Radiology
·
133d
Cleared
Apr 01, 2022
SKANRAD 400
K220518
·
KPR
Radiology
·
37d
Cleared
Mar 04, 2022
Skanmobile, Skanmobile-Dr
K212940
·
IZL
Radiology
·
170d
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4
Radiology
4