FDA.reportPublic FDA data

Respiratory Belt with Bladder, Small

Primary DI
B365603100
Brand
Respiratory Belt with Bladder, Small
Company
Aktina Corp.
Model
60-310
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032248000
K991546000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032248000PRECISE CARBON FIBER TABLE TOP, MODEL 11-999Aktina Medical Physics Corp.2003-09-25IYE
K991546000AKTINA MEDICAL PHYSICS CORPORATION TILT BOARDAktina Medical Physics Corp.1999-07-30IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B365603100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
X-ray system compression device, abdominalA mechanically, electronically or software-controlled component of a diagnostic or therapeutic x-ray system that is used to flatten and stabilize the abdomen during imaging procedures and/or treatments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
787178920
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B365112200Head and Neck Overlay with Shoulder Restraints11-2202016-09-24
B365805000Navigator CS80-5002016-09-24
B3658080000isoPoint Validation Software80-8002024-07-01
B365601900Belly Compression Arch Kit60-1902016-09-24
B365603110Respiratory Belt with Bladder, Medium60-3112016-09-28
B365603120Respiratory Belt with Bladder, Large60-3122016-09-28
B365503710Transport Cart, SRS Cones50-3712021-05-21
B365503720Bar Code Reader Kit50-3722021-05-21
B365503750Film Holder50-3752021-05-21
B365503022100Circular Small Field Cone Insert, Elekta, 21mm50-302-2102016-10-04
B365503022200Circular Small Field Cone Insert, Elekta, 22mm50-302-2202016-10-04
B365503022300Circular Small Field Cone Insert, Elekta, 23mm50-302-2302016-10-04
B365503022400Circular Small Field Cone Insert, Elekta, 24mm50-302-2402016-10-04
B365503022500Circular Small Field Cone Insert, Elekta, 25mm50-302-2502016-10-04
B365503022600Circular Small Field Cone Insert, Elekta, 26mm50-302-2602016-10-04
B365503022700Circular Small Field Cone Insert, Elekta, 27mm50-302-2702016-10-04
B365503022800Circular Small Field Cone Insert, Elekta, 28mm50-302-2802016-10-04
B365503022900Circular Small Field Cone Insert, Elekta, 29mm50-302-2902016-10-04
B365503023000Circular Small Field Cone Insert, Elekta, 30mm50-302-3002016-10-04
B365503023100Circular Small Field Cone Insert, Elekta, 31mm50-302-3102016-10-06

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