510k
Database
Specialties
Anesthesiology
4087
Cardiovascular
10594
Chemistry
9338
Dental
6705
Ear, Nose, Throat
2118
Gastroenterology & Urology
5592
General & Plastic Surgery
9071
General Hospital
7397
Hematology
2115
Immunology
2722
Medical Genetics
18
Microbiology
5215
Neurology
3162
Obstetrics & Gynecology
2044
Ophthalmic
1572
Orthopedic
13214
Pathology
694
Physical Medicine
1754
Radiology
8855
Toxicology
2273
Categories
GEX
Powered Laser Surgical Instrument
1545
GEI
Electrosurgical, Cutting &...
1262
LLZ
System, Image Processing,...
1197
HRS
Plate, Fixation, Bone
1010
IYN
System, Imaging, Pulsed Doppler,...
879
LNH
System, Nuclear Magnetic...
841
ESD
Hearing Aid, Air-conduction,...
812
JWH
Prosthesis, Knee,...
809
GCJ
Laparoscope, General & Plastic...
802
DZE
Implant, Endosseous, Root-form
762
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
US
GuideAI Health
Medical Device Manufacturer
·
US , Boston , MA
GuideAI Health - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2026
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - GuideAI Health
Radiology
✕
1
devices
1-1 of 1
Filters
Cleared
Jun 18, 2026
Vascular Assist Occlusion Triage (VAOT) (v1.0)
K260729
·
QAS
Radiology
·
104d
Filters
Filter by Specialty
All
1
Radiology
1