FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
Miscellaneous
Miscellaneous
PCS
Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
2
Product Code
PDK
Cream For X-Ray Attenuation
2
Product Code
QBS
Radiological Computer Assisted Detection/Diagnosis Software For Fracture
2
Product Code
QDQ
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
2
Product Code
QJU
Image Acquisition And/Or Optimization Guided By Artificial Intelligence
2
Product Code
QRN
Radiation Therapy Marking Device
2
Product Code
KTA
Medium, Contrast, Radiologic
U
Product Code
K
80
0843
MEDEFIZZ A & MEDEFIZZ B
U
Cleared 510(K)
K
80
0840
MEDEFOAM-2
U
Cleared 510(K)
K
80
0839
MEDESCAN
U
Cleared 510(K)
K
80
0841
MEDEBAR M
U
Cleared 510(K)
K
80
0842
MEDEBAR XAC-90
U
Cleared 510(K)
K
80
0844
MEDEBAR XL
U
Cleared 510(K)
K
80
0459
BARIUM SULFATE, USP IN SUSPENSION
U
Cleared 510(K)
K
76
0736
BARIMEX, BARIUM SULFATE COMPOUND
U
Cleared 510(K)
LMZ
Applicator, Hyperthermia, Interstitial
3
Product Code
LNB
Applicator, Hyperthermia, Deep Heating, Ultrasound
3
Product Code
LNC
Applicator, Hyperthermia, Superficial, Rf/Microwave
3
Product Code
LOC
System, Rf/Microwave Hyperthermia, Cancer Treatment
3
Product Code
LSY
Ultrasound, Hyperthermia, Cancer Treatment
3
Product Code
MJS
Contrast Media, Ultrasound
3
Product Code
MOT
Irradiator, Blood To Prevent Graft Versus Host Disease
U
Product Code
NAN
Tester, Acoustic, Bone Quality
3
Product Code
NAW
Microspheres Radionuclide
3
Product Code
NCL
Imager, Breast, Electrical Impedance
3
Product Code
OLQ
Cross-Sectional Mammographic Xray System
3
Product Code
OTE
Digital Breast Tomosynthesis
3
Product Code
PAA
Automated Breast Ultrasound
3
Product Code
QNK
Optoacoustic Imaging System
3
Product Code
QUV
Phase-Changing Fiducial Marker For Radiation Therapy
2
Product Code
QVA
Fludeoxyglucose F18-Guided Radiation Therapy System
2
Product Code
QVD
Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan
2
Product Code
QXR
Vaginal Hydrogel Packing System
2
Product Code
QVW
Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led
N
Product Code
QZL
Post-Ablation Tissue Response Prediction Software
2
Product Code
QWO
Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
2
Product Code
SAO
Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
2
Product Code
Submissions with No Product Code
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
RA
/
RA-misc
/
KTA
/
K800841
View Source
MEDEBAR M
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Loading...
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
Miscellaneous
PCS
Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
PDK
Cream For X-Ray Attenuation
QBS
Radiological Computer Assisted Detection/Diagnosis Software For Fracture
QDQ
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
QJU
Image Acquisition And/Or Optimization Guided By Artificial Intelligence
QRN
Radiation Therapy Marking Device
KTA
Medium, Contrast, Radiologic
K
80
0843
MEDEFIZZ A & MEDEFIZZ B
K
80
0840
MEDEFOAM-2
K
80
0839
MEDESCAN
K
80
0841
MEDEBAR M
K
80
0842
MEDEBAR XAC-90
K
80
0844
MEDEBAR XL
K
80
0459
BARIUM SULFATE, USP IN SUSPENSION
K
76
0736
BARIMEX, BARIUM SULFATE COMPOUND
LMZ
Applicator, Hyperthermia, Interstitial
LNB
Applicator, Hyperthermia, Deep Heating, Ultrasound
LNC
Applicator, Hyperthermia, Superficial, Rf/Microwave
LOC
System, Rf/Microwave Hyperthermia, Cancer Treatment
LSY
Ultrasound, Hyperthermia, Cancer Treatment
MJS
Contrast Media, Ultrasound
MOT
Irradiator, Blood To Prevent Graft Versus Host Disease
NAN
Tester, Acoustic, Bone Quality
NAW
Microspheres Radionuclide
NCL
Imager, Breast, Electrical Impedance
OLQ
Cross-Sectional Mammographic Xray System
OTE
Digital Breast Tomosynthesis
PAA
Automated Breast Ultrasound
QNK
Optoacoustic Imaging System
QUV
Phase-Changing Fiducial Marker For Radiation Therapy
QVA
Fludeoxyglucose F18-Guided Radiation Therapy System
QVD
Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan
QXR
Vaginal Hydrogel Packing System
QVW
Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led
QZL
Post-Ablation Tissue Response Prediction Software
QWO
Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
SAO
Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
Submissions with No Product Code
Subpart B—Diagnostic Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart F—Therapeutic Devices
Subpart G—Miscellaneous Devices
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
RA
/
RA-misc
/
KTA
/
K800841
View Source
MEDEBAR M
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Loading...