FDA.reportPublic FDA data

Dolphin

Primary DI
EIBAE30620250
Brand
Dolphin
Company
IBA Dosimetry GmbH
Model
E3062025
Device description
T2D Mini Elekta Korea
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072374000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072374000COMPASSScanditronix Wellhofer GmbH2007-12-07IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EIBAE30620251PackageHIBCC1In Commercial Distribution
EIBAE30620250PrimaryHIBCC0

Contacts#

Phone, Email table
PhoneEmail
+861080809107ServiceAPAC@iba-group.com
+49912860738service@iba-group.com
+1 901 386-2242USService@iba-group.com

Regulatory Flags#

DUNS number
332599307
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EIBAE30635000myQA StarTrack³, including Energy Verification Plates and SoftwareE3063500ST03-0002026-04-24
EIBAMQ040000myQA AcceptMQ04-0002016-09-09
EIBASR020010myQA® SRS Phantom CyberknifeSR02001SR02-0012023-10-10
EIBAHA03000V0040Lift tableHA03-000#004HA03-000#0042023-09-19
EIBAHA03010V0040Lift tableHA03-010#004HA03-010#0042023-09-19
EIBAHA050000Water ReservoirHA05-000HA05-0002023-08-03
EIBAHA050100Water ReservoirHA05-010HA05-0102023-08-03
EIBAE30702000myQA SRS Detector Cyberknife editionE3070200SR01-1002023-07-25
EIBAE30702001myQA SRS Detector Cyberknife editionE3070200SR01-1002023-07-25
EIBAE20702000DOSE-XE2070200DX00-0002023-04-13
EIBAE20703000DOSE-XE2070300DX00-1002023-04-13
EIBABS505000miniPhantomBS50-500BS50-5002023-04-12
EIBABS505001miniPhantomBS50-500BS50-5002023-04-12
EIBAE14000300CCU Steuerelektronik PTE14000302023-04-12
EIBAHA031150Lift tableHA03-115HA03-1152023-04-12
EIBAHA032300Lift tableHA03-230HA03-2302023-04-12
EIBAE30350100"CQA ""StarTrack"""E3035010BS80-000, BS80-010, BS80-1002016-09-09
EIBAM98000000IMRT - Bodyphantom M9800000BS40-0002016-09-09
EIBA120104HSE0KermaX-plus1120-104 HS E2021-12-17
EIBA120104HST0KermaX-plus1120-104 HS T2021-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817355027046KLARITY MEDICALKlarity Medical Products, LLCIYE2026-11-04
00840510401696KLARITY MEDICALKlarity Medical Products, LLCIYE2026-11-04
00841439120590TotalRTQfixIYE2026-11-04
00817355025400KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-28
00850065937403eMotusEMPNIA INC.IYE2026-10-27
00850065937410eMotusEMPNIA INC.IYE2026-10-27
00817355025127KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-26
00840510401672KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-23
00840510401689KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-23
00840510401665KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-21
00840510401658KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-08
00840510401627KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401634KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401641KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00850065937007eMotusEMPNIA INC.IYE2026-09-21
00850065937014eMotusEMPNIA INC.IYE2026-09-21
00850065937021eMotusEMPNIA INC.IYE2026-09-21
00850065937038eMotusEMPNIA INC.IYE2026-09-21
00850065937045eMotusEMPNIA INC.IYE2026-09-21
00850065937052eMotusEMPNIA INC.IYE2026-09-21
00850065937069eMotusEMPNIA INC.IYE2026-09-21
00850065937076eMotusEMPNIA INC.IYE2026-09-21
00850065937083eMotusEMPNIA INC.IYE2026-09-21
00850065937090eMotusEMPNIA INC.IYE2026-09-21
00850065937106eMotusEMPNIA INC.IYE2026-09-21
00850065937113eMotusEMPNIA INC.IYE2026-09-21
00850065937120eMotusEMPNIA INC.IYE2026-09-21
00850065937137eMotusEMPNIA INC.IYE2026-09-21
00850065937144eMotusEMPNIA INC.IYE2026-09-21
00850065937151eMotusEMPNIA INC.IYE2026-09-21