FDA.reportPublic FDA data

SagiPlan® V.2.x Prostate Module Add-on SW

Primary DI
04049223106751
Brand
SagiPlan® V.2.x Prostate Module Add-on SW
Company
Eckert & Ziegler BEBIG GmbH
Model
1374-0610#01
Catalog number
1374-0600
Published
2016-11-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUJSystem,Planning,Radiation Therapy Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUJSystem, Planning, Radiation Therapy TreatmentRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141900000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141900000SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULEEckert & Ziegler Bebig GmbH2015-05-20MUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049223106751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049223106751040492231067514049223106751

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy softwareAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4930941084130info@bebig.com

Regulatory Flags#

DUNS number
331080432
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049223114527CT/MR Obturator for Plastic Needle, L= 300 mm (à 1 pc)LLH02-300LLH02-3002016-10-10
04049223104047Opening Forceps for Holding DiscsLAH05-03#05LAH05-032020-12-21
04049223132088SagiPlan® 2.x Software1374-0600#031374-06002020-07-01
04049223132613Universal Applicator incl. plug, D=3mm, L=1400mm (non sterile)LAA1400-GYN#02LAA1400-GYN2020-03-31
04049223133634Universal Applicator, marked, D=2mm, L=1200mm (sterile)LLA1200-20#04LLA1200-202020-03-31
04049223101077Flexible Catheter Single Leader, D=1.65mm, L=300mmLLA300-F#02-SPLLA300-F2016-10-06
04049223101169Plastic Needle, D=1.65mm, L=150mm, 16GLLA150-KB#02-SPLLA150-KB2016-10-06
04049223101176Plastic Needle, D=1.65mm, L=200mm, 16GLLA200-KB#02-SPLLA200-KB2016-10-06
04049223101183Plastic Needle, D=1.65mm, L=300mm, 16GLLA300-KB#02-SPLLA300-KB2016-10-06
04049223101190Cutter for flexible CathetersLAH06-01#03LAH06-012016-10-05
04049223101206CT/MR Intrauterine Tube straight, thin, D=3.5mmLCT01-01#03LCT01-012016-10-07
04049223101213CT/MR Intrauterine Tube 15°, thin, D=3.5mm, IUL=25mmLCT02-01#03LCT02-012016-10-07
04049223101220CT/MR Intrauterine Tube 20°, thin, D=3.5mm, IUL=30mmLCT03-01#03LCT03-012016-10-07
04049223101237CT/MR Intrauterine Tube 25°, thin, D=3.5mm, IUL=35mmLCT04-01#03LCT04-012016-10-07
04049223101244CT/MR Intrauterine Tube 40°, thin, D=3.5mm, IUL=35mmLCT05-01#03LCT05-012016-10-07
04049223101251CT/MR Intrauterine Tube 30°, thin, D=3.5mm, IUL=65mmLCT06-01#03LCT06-012016-10-07
04049223101770CT/MR Fletcher Ovoid Tubes right and leftLCT82-02#03LCT82-022016-10-07
04049223102722Vaginal Cylinder with variable length, D=20mm, L=120mmLAZ07-01#04LAZ07-012016-10-07
04049223102739CT/MR-Vag. Cylinder with variable length D=20mm L=120mmLCZ07-01#04LCZ07-012016-10-07
04049223102784Channel Coding for Needles and Catheters (Channel 1)LLZ03-01LLZ03-012016-10-10

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Primary DI, Brand, Company table
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05060494200091XBeam XSTRAHL LIMITEDMUJ2026-01-19
03770019940013ART-PlanTHERAPANACEAMUJ2025-12-10
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04056869959009syngo.via RT Image SuiteSiemens Healthcare GmbHMUJ2025-11-18
04068151011388syngo.via RT Image SuiteSiemens Healthcare GmbHMUJ2025-11-18
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00860183001542Kit, Container, Head ImmobilizerZAP SURGICAL SYSTEMS, INC.MUJ2025-11-17
00860183001573ZAP-Axon Treatment Planning SystemZAP SURGICAL SYSTEMS, INC.MUJ2025-11-17
00860183001580DoseGuardZAP SURGICAL SYSTEMS, INC.MUJ2025-11-17
00860183001597Kit, Container, Fixation Pins, ImmobilizerZAP SURGICAL SYSTEMS, INC.MUJ2025-11-17
08717213058118NANucletron B.V.MUJ2025-11-13
05060608881574Plan AISUN NUCLEAR CORP.MUJ2025-11-07
06429830064237Dose+Mvision AI OyMUJ2025-10-03
07350002010891RayCareRaysearch Laboratories AB (Publ)MUJ2025-09-30
04056481146030RT Elements Brainlab SEMUJ2025-06-25
07350002010839RayCareRaysearch Laboratories AB (Publ)MUJ2025-04-30
07350002010884RayStationRaysearch Laboratories AB (Publ)MUJ2025-04-10
00040695000008Radiation Planning Assistant (RPA)The University of Texas M. D. Anderson Cancer CenterMUJ2025-01-28
00855141006349Eclipse Treatment Planning SystemVARIAN MEDICAL SYSTEMS, INC.MUJ2024-12-20
00856100006370ARIA Radiation Therapy ManagementVARIAN MEDICAL SYSTEMS, INC.MUJ2024-12-20
00859032007170Panther TPSProwess, Inc.MUJ2024-12-19
00859032007194Panther TPSProwess, Inc.MUJ2024-12-19
00859032007200Panther TPSProwess, Inc.MUJ2024-12-19