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
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
K
20
1177
RadGil2
U
Cleared 510(K)
K
18
1737
Raycell MK1
U
Cleared 510(K)
K
17
2087
SANGRAY
U
Cleared 510(K)
K
16
1324
Raycell Mk2
U
Cleared 510(K)
K
08
2921
RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400
U
Cleared 510(K)
K
05
1065
RAYCELL X-RAY BLOOD IRRADIATOR
U
Cleared 510(K)
K
05
0963
GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN
U
Cleared 510(K)
K
03
2684
RAYCELL
U
Cleared 510(K)
K
97
4210
SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000
U
Cleared 510(K)
K
96
3497
GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0
U
Cleared 510(K)
Show All 14 Submissions
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 30 November 2024 at 11:09 am
RA
/
RA-misc
/
MOT
/
K082921
View Source
RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K082921
510(k) Type
Traditional
Applicant
RAD SOURCE TECHNOLOGIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/17/2009
Days to Decision
139 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
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
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
K
20
1177
RadGil2
K
18
1737
Raycell MK1
K
17
2087
SANGRAY
K
16
1324
Raycell Mk2
K
08
2921
RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400
K
05
1065
RAYCELL X-RAY BLOOD IRRADIATOR
K
05
0963
GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN
K
03
2684
RAYCELL
K
97
4210
SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000
K
96
3497
GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0
Show All 14 Submissions
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
/
MOT
/
K082921
View Source
RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K082921
510(k) Type
Traditional
Applicant
RAD SOURCE TECHNOLOGIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/17/2009
Days to Decision
139 days
Submission Type
Summary