FDA.reportPublic FDA data

Balloon Applicator

Primary DI
00858012005984
Brand
Balloon Applicator
Company
Icad, Inc.
Model
720846
Catalog number
AB2070
Device description
3-4 cm Spherical, Extended Length
Published
2019-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JADSystem, Therapeutic, X-Ray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JADSystem, Therapeutic, X-RayRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090914000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090914000AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067EXoft, Inc.2009-07-16JAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858012005984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858012005984008580120059848580120059840858012005984

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative/postoperative therapeutic x-ray system balloon applicator kitA sterile collection of devices that is a component of an intraoperative/postoperative therapeutic x-ray system designed for the administration of radiation in certain clinical applications, typically intraoperatively within a resected breast tumour bed. It typically consists of a set of cavity ball gauges used for measurement of the cavity, and a set of graduated size balloon applicators. The required size of applicator is intended to be placed in the tumour cavity after lumpectomy and inflated, and the inner catheter is designed to hold the tube of the x-ray source, stabilized by a probe guard, during radiotherapy treatment. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
108870254
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850008977176ProFound AI V3.03.02021-05-17
00850008977183PowerLook AMP with Density Assessment GE USDSC012-022021-05-17
00850008977190PowerLook AMP with Density Assessment GE OUSDSC012-032021-05-17
00858012005090PowerLook AMP SLD GE OUSDSC010-01-EU2021-05-17
00858012005106PowerLook AMP SLD GE OUS DirectDSC010-12-EU2021-05-17
00858012005113PowerLook AMP SLD Siemens OUSDSC010-03-EU2021-05-17
00858012005120PowerLook AMP SLD Fuji OUSDSC010-04-EU2021-05-17
00858012005137PowerLook AMP SLD Hologic OUSDSC010-05-EU2021-05-17
00858012005144PowerLook AMP SLD GiottoDSC010-062021-05-17
00858012005151PowerLook AMP SLD Philips OUSDSC010-07-EU2021-05-17
00858012005168PowerLook AMP SLD PlanmedDSC010-082021-05-17
00858012005175PowerLook AMP SLD Agfa CRDSC010-092021-05-17
00858012005236PowerLook PRO Tomo Detection and SLD, GEV1.1DSC014-01-EU2021-05-17
00858012005250PowerLook PRO Tomo Detection and SLD, GEV1.1DSC014-02-EU2021-05-17
00858012005809Powerlook PRO Hardware Upgrade, SLDV7.2DSC017-02-ROW2021-05-17
00858012005823Powerlook PRO Hardware Upgrade, SLDV7.2DSC017-03-ROW2021-05-17
00858012005830PowerLook AMP PRO, SLD, GE, ROWV7.2DSC017-01-ROW2021-05-17
00858012005847PowerLook AMP PRO, SLD, GE, ROWV7.2DSC017-04-ROW2021-05-17
00858012005960ProFound AI2.12019-07-11
00858012005007SecondLook Digital (SLD)V7.2DS02062014-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049539105509INTRABEAM Spherical Sizer SetCarl Zeiss Meditec AGJAD2025-06-20
04049539105516INTRABEAM SMART Spherical ApplicatorCarl Zeiss Meditec AGJAD2025-05-14
04049539105523INTRABEAM SMART Spherical Applicator Carl Zeiss Meditec AGJAD2025-05-14
04049539105530INTRABEAM SMART Spherical Applicator Carl Zeiss Meditec AGJAD2025-05-14
04049539105547INTRABEAM SMART Spherical Applicator (35 mm)Carl Zeiss Meditec AGJAD2025-05-14
04049539105554INTRABEAM SMART Spherical Applicator (35mm)Carl Zeiss Meditec AGJAD2025-05-14
04049539105561INTRABEAM SMART Spherical Applicator (40mm)Carl Zeiss Meditec AGJAD2025-05-14
04049539105578INTRABEAM SMART Spherical Applicator (45mm)Carl Zeiss Meditec AGJAD2025-05-14
04049539064080INTRABEAMCarl Zeiss Meditec AGJAD2025-04-01
04049539066503INTRABEAM SMART StandCarl Zeiss Meditec AGJAD2025-04-01
05060494200084X80 / RADiant / PhotoElectric Therapy SystemXSTRAHL LIMITEDJAD2024-05-08
08717213057760EsteyaNucletron B.V.JAD2022-08-16
00089904010728Action®ACTION PRODUCTS, INC.JAD2021-03-23
00628341930116Bolus - Gel (film)CDR Systems IncJAD2019-12-31
00628341930123Bolus - Gel (w/o Film)CDR Systems IncJAD2019-12-31
00850008977008Balloon ApplicatorIcad, Inc.JAD2019-11-05
00850008977015Balloon ApplicatorIcad, Inc.JAD2019-11-05
00858012005991Balloon ApplicatorIcad, Inc.JAD2019-11-05
10850002237013SensusSENSUS HEALTHCARE, INC.JAD2018-12-12
10850002237020SensusSENSUS HEALTHCARE, INC.JAD2018-12-12
10850002237037SensusSENSUS HEALTHCARE, INC.JAD2018-12-12
00089904008398Action®ACTION PRODUCTS, INC.JAD2018-07-06
08717213038820EsteyaNucletron B.V.JAD2018-06-12
08717213038837EsteyaNucletron B.V.JAD2018-06-12
08717213038844EsteyaNucletron B.V.JAD2018-06-12
00089904008077Action®ACTION PRODUCTS, INC.JAD2018-06-11
00089904007971Action®ACTION PRODUCTS, INC.JAD2018-04-06
00089904007964Action®ACTION PRODUCTS, INC.JAD2018-03-12
00089904007810Action®ACTION PRODUCTS, INC.JAD2018-01-29
00089904010827Action®ACTION PRODUCTS, INC.JAD2018-01-29