FDA.reportPublic FDA data

HDR X-ray Source 2.2

Primary DI
00858012005304
Brand
HDR X-ray Source 2.2
Company
Icad, Inc.
Model
720697
Catalog number
S7551
Device description
Axxent HDR X-Ray Source 50 cm HUT
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K122951000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122951000XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110Icad, Inc.2013-01-17JAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858012005304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858012005304008580120053048580120053040858012005304

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative/postoperative therapeutic x-ray system x-ray sourceA mains electricity (AC-powered) electronic component of an intraoperative/postoperative therapeutic x-ray system designed to generate the x-ray radiation for use primarily in the treatment of cancer (e.g., breast, brain, skin), typically during or after an operation for tumour resection. It uses voltages typically less than 50 kV to accelerate electrons through a drift tube onto a gold target where low energy x-ray radiation is generated and emitted isotropically. It is typically used with (covered by) various applicators for the different clinical applications, and mounted on a mobile (on wheels) floor stand.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
108870254
Device count
1
Serial number
true
Manufacturing 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

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Primary DI, Brand, Company table
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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
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00089904008398Action®ACTION PRODUCTS, INC.JAD2018-07-06
08717213038820EsteyaNucletron B.V.JAD2018-06-12
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