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Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
OEW
Tracking, Soft Tissue, Intraoperative
2
Product Code
K
14
3024
CAS-One Liver
2
Cleared 510(K)
K
10
1979
EXPLORER LIVER (PASSIVE TRACKING)
2
Cleared 510(K)
K
09
3494
LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM
2
Cleared 510(K)
K
07
1063
LINASYS
2
Cleared 510(K)
ONA
Computer Assisted Hair Harvesting System
2
Product Code
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Toxicology
Review Panel
Medical Genetics
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Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
SU
/
subpart-e—neurological-surgical-devices
/
OEW
/
K093494
View Source
LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K093494
510(k) Type
Special
Applicant
PATHFINDER THERAPEUTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/30/2010
Days to Decision
140 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
OEW
Tracking, Soft Tissue, Intraoperative
K
14
3024
CAS-One Liver
K
10
1979
EXPLORER LIVER (PASSIVE TRACKING)
K
09
3494
LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM
K
07
1063
LINASYS
ONA
Computer Assisted Hair Harvesting System
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
subpart-e—neurological-surgical-devices
/
OEW
/
K093494
View Source
LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K093494
510(k) Type
Special
Applicant
PATHFINDER THERAPEUTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/30/2010
Days to Decision
140 days
Submission Type
Summary