FDA.reportPublic FDA data

INTRABEAM

Primary DI
04049539064080
Brand
INTRABEAM
Company
Carl Zeiss Meditec AG
Model
700
Device description
The INTRABEAM 700 is a medical device used in the context of Radiation Therapy. It is used unsterile given that it shall be placed in the environment of the operating theatre, but outside of the sterile medical environment.It is intended to deliver, monitor, and report a radiation therapy treatment.
Published
2025-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K241174000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241174000INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)Carl Zeiss Meditec, AG2025-01-10JAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049539064080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049539064080040495390640804049539064080

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative/postoperative therapeutic x-ray systemA mobile (on wheels) assembly of mains electricity (AC-powered) devices designed to produce low-energy x-rays used for therapeutic purposes, primarily in the treatment of cancer (e.g., breast, brain, skin) typically during or after an operation for tumour resection. It uses a miniature electronic X-ray source (50kV maximum) attached to one of various types and sizes of applicators specific to the clinical application (e.g., from within a resected breast tumour site). It typically consists of an x-ray source and an applicator mounted on a floor stand, verification tools, control unit, and user interface. It may be used in an operating room (OR) or other clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342228620
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049471097153SL 220SL 8002026-01-13
04049471091489VISULASVISULAS yag2026-01-12
04049471091496VISULASVISULAS combi2026-01-12
04049471091502VISULAS greenVISULAS green2026-01-12
04049471090260AT 030AT 0302018-12-04
04049471091229VISULAS TrionVISULAS Trion, VISULAS Trion VITE2016-09-20
04049471091403VISULAS 532sVISULAS 532s, VISULAS 532s VITE2016-09-20
04049539072122QEVO72122017-08-24
04049539072139QEVO ECU72132017-08-24
04049539105509INTRABEAM Spherical Sizer Set309121-9100-0002025-06-20
04049539105516INTRABEAM SMART Spherical Applicator309120-9015-002025-05-14
04049539105523INTRABEAM SMART Spherical Applicator 309120-9020-0002025-05-14
04049539105530INTRABEAM SMART Spherical Applicator 309120-9025-0002025-05-14
04049539105547INTRABEAM SMART Spherical Applicator (35 mm)309120-9035-0002025-05-14
04049539105554INTRABEAM SMART Spherical Applicator (35mm)309120-9035-0002025-05-14
04049539105561INTRABEAM SMART Spherical Applicator (40mm)309120-9040-0002025-05-14
04049539105578INTRABEAM SMART Spherical Applicator (45mm)309120-9045-0002025-05-14
04049539101563INTRABEAM® Spherical Applicator 1.5 cm304534-6000-5572017-04-14
04049539101570INTRABEAM® Spherical Applicator 2.0 cm304534-6000-5582017-04-14
04049539101587INTRABEAM® Spherical Applicator 2.5 cm304534-6000-5592017-04-14

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
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
00858012005984Balloon 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