FDA.reportPublic FDA data

Xstrahl 100 X-Ray System

Primary DI
05060494200015
Brand
Xstrahl 100 X-Ray System
Company
XSTRAHL LIMITED
Model
Xstrahl 100 X-Ray System
Device description
Xstrahl 100 X-Ray System
Published
2017-01-27
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060494200015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060494200015050604942000155060494200015

GMDN Terms#

Term, Definition table
TermDefinition
Stationary orthovoltage therapeutic x-ray systemAn assembly of devices designed to produce low-energy x-rays used for therapeutic purposes, primarily in the treatment of skin cancer (e.g., basal cell or squamous cell carcinoma) or other skin conditions (e.g., psoriasis, keloid). The radiation source typically uses a tube voltage of between approximately 100 kV and 500 kV and will be used in conjunction with a variety of topical applicators. The main system is ceiling- or wall-mounted (fixed) in a radiotherapy suite or other clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
491314738
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060494200091XBeam v22026-01-19
05060494200084X80 / RADiant / PhotoElectric Therapy SystemRADiant Aura2024-05-08
05060494200008Xstrahl Photoelectric Therapy SystemXstrahl Photoelectric Therapy System2017-07-03
05060494200022Xstrahl 150 X-Ray System FloorXstrahl 150 X-Ray System Floor2017-01-27
05060494200039Xstrahl 150 X-Ray System - CeilingXstrahl 150 X-Ray System - Ceiling2017-01-27
05060494200046Xstrahl 200 X-Ray System - FloorXstrahl 200 X-Ray System - Floor2017-01-27
05060494200053Xstrahl 200 X-Ray System - CeilingXstrahl 200 X-Ray System - Ceiling2017-01-27
05060494200060Xstrahl 300 X-Ray System - FloorXstrahl 300 X-Ray System - Floor2017-01-27
05060494200077Xstrahl 300 X-Ray System CeilingXstrahl 300 X-Ray System Ceiling2017-01-27

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
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