510k
Database
Specialties
Anesthesiology
447
Cardiovascular
1362
Chemistry
334
Dental
1054
Ear, Nose, Throat
194
Gastroenterology & Urology
807
General & Plastic Surgery
1777
General Hospital
1210
Hematology
121
Immunology
84
Medical Genetics
7
Microbiology
419
Neurology
764
Obstetrics & Gynecology
334
Ophthalmic
210
Orthopedic
2420
Pathology
44
Physical Medicine
408
Radiology
1972
Toxicology
143
Categories
GEX
Powered Laser Surgical Instrument
290
LLZ
System, Image Processing,...
281
QIH
Automated Radiological Image...
251
GEI
Electrosurgical, Cutting &...
251
IYN
System, Imaging, Pulsed Doppler,...
240
HRS
Plate, Fixation, Bone
235
LZA
Polymer Patient Examination Glove
204
OLO
Orthopedic Stereotaxic Instrument
198
NHA
Abutment, Implant, Dental,...
187
MAX
Intervertebral Fusion Device...
167
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General Scanning, Inc.
Medical Device Manufacturer
·
US , Watertown , MA
General Scanning, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1992
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - General Scanning, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 19, 1998
LD2000 SERIES
K980565
·
LMA
Radiology
·
34d
Cleared
Dec 04, 1997
DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)
K973411
·
LMA
Radiology
·
86d
Cleared
Nov 30, 1992
NUCLEAR MEDICINE LASER IMAGER
K923536
·
LMC
Radiology
·
137d
Filters
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3
Radiology
3