510k
Database
Specialties
Anesthesiology
433
Cardiovascular
1312
Chemistry
327
Dental
1011
Ear, Nose, Throat
191
Gastroenterology & Urology
782
General & Plastic Surgery
1710
General Hospital
1114
Hematology
117
Immunology
83
Medical Genetics
7
Microbiology
413
Neurology
735
Obstetrics & Gynecology
323
Ophthalmic
199
Orthopedic
2374
Pathology
44
Physical Medicine
393
Radiology
1906
Toxicology
141
Categories
GEX
Powered Laser Surgical Instrument
282
LLZ
System, Image Processing,...
267
QIH
Automated Radiological Image...
247
GEI
Electrosurgical, Cutting &...
242
IYN
System, Imaging, Pulsed Doppler,...
233
HRS
Plate, Fixation, Bone
232
OLO
Orthopedic Stereotaxic Instrument
194
NHA
Abutment, Implant, Dental,...
181
LZA
Polymer Patient Examination Glove
172
MAX
Intervertebral Fusion Device...
164
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Precision Therapy Intl., Inc.
Medical Device Manufacturer
·
US , North Miami Beach , FL
Precision Therapy Intl., Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1995
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Precision Therapy Intl., Inc.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Sep 20, 2002
PRECISEPLAN 2.0
K022411
·
MUJ
Radiology
·
58d
Cleared
Aug 23, 2000
RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0
K002240
·
MUJ
Radiology
·
30d
Cleared
Sep 09, 1999
RENDER-PLAN 3-D
K992864
·
MUJ
Radiology
·
15d
Cleared
Aug 16, 1995
HERCULES RADIATION THERAPY COUCH
K950061
·
IYE
Radiology
·
222d
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4
Radiology
4