FDA.reportPublic FDA data

SCINTRON

Primary DI
04260484140050
Brand
SCINTRON
Company
MiE medical imaging electronics GmbH
Model
SCINTRON
Device description
Gamma Camera Workstation for Acquisition, Reviewing and Processing
Published
2018-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPSSystem, Tomography, Computed, Emission

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPSSystem, Tomography, Computed, EmissionRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101013000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101013000MODIFICATION TO SCINTRON IVMiegmbh2010-06-07KPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260484140050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260484140050042604841400504260484140050

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49419499770mie@miegermany.de

Regulatory Flags#

DUNS number
537604915
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260484140036ECAM-SCINTRONECAM-SCINTRON2022-11-29
04260484140043MiE - Gamma Camera SystemsSYNGULA-SCINTRON2022-11-29
04260484140074MiE - Gamma Camera SystemsPICOLA-SCINTRON2022-11-29
04260484140067ANCORISANCORIS2021-06-11
04260484140029ECAT Scintron PETECAT Scintron PET2018-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B133NEUROQ412610120NeuroQSYNTERMED INCORPORATEDKPS2026-10-15
00860013868918MICSI-PETMicroStructure Imaging, Inc.KPS2026-10-14
07649998522014NeuroLFPositrigo AGKPS2026-07-28
07649998522021NeuroLFPositrigo AGKPS2026-07-28
07649998522038NeuroLFPositrigo AGKPS2026-07-28
07649998522045NeuroLFPositrigo AGKPS2026-07-28
00850040177145UltraSPECTUltraspect Usa, LLCKPS2026-07-08
B133ECTB422606160Cardiac ToolboxSYNTERMED INCORPORATEDKPS2026-07-02
B133NEUROQ412605150NeuroQSYNTERMED INCORPORATEDKPS2026-06-10
00841962120548Alpine Stirrups, Metric, LeftQfixKPS2026-04-14
00841962120555Alpine Stirrups, Metric, RightQfixKPS2026-04-14
00859873006240HermiaHermes Medical Solutions ABKPS2026-03-05
B133NEUROQ412601160NeuroQSYNTERMED INCORPORATEDKPS2026-03-04
B133ECTB422512090Cardiac ToolboxSYNTERMED INCORPORATEDKPS2026-02-26
07290108670523D-SPECT RefurbishedSPECTRUM DYNAMICS MEDICAL, INCKPS2026-02-09
04068151020472BIOGRAPH OneSiemens Healthineers AGKPS2026-01-20
00841962120456Alta for HexaPODQfixKPS2026-01-14
04068151048070Biograph Trinion.X EP9 CT64SIEMENS MEDICAL SOLUTIONS USA, INC.KPS2026-01-09
00841962120388Lumen AirShuttleQfixKPS2025-12-02
00841962120395Symphony Locating Bar, PH StyleQfixKPS2025-12-02
10841962119457Symphony Locating Bar, Prodigy2™QfixKPS2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixKPS2025-10-23
08809873532005BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532012BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532029BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532036BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532043BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532050BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
00841439114841ZiFix TraverseMEDTEC, INC.KPS2025-09-12
00841962120340Edge Guide SystemQfixKPS2025-09-11