FDA.reportPublic FDA data

MiE - Gamma Camera Systems

Primary DI
04260484140043
Brand
MiE - Gamma Camera Systems
Company
MiE medical imaging electronics GmbH
Model
SYNGULA-SCINTRON
Device description
The MIE - Gamma Camera Systems for nuclear medicine is used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients.
Published
2022-11-29
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
IYXCamera, Scintillation (Gamma)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYXCamera, Scintillation (Gamma)Radiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053086000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053086000MIE - GAMMA CAMERA SYSTEMSMie America, Inc.2006-01-27KPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260484140043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260484140043042604841400434260484140043

GMDN Terms#

Term, Definition table
TermDefinition
Stationary gamma camera systemAn assembly of static diagnostic devices designed to record, quantify, and analyse radionuclide emissions (primarily gamma rays) produced during the decay of radiopharmaceuticals or other radiation emitting materials injected into, or ingested by, a patient. It consists of an analogue or digital detector based nuclear medicine (NM) planar imaging system, crystal(s), a collimator and a set of photomultiplier tubes or photo diodes. Gamma rays pass through holes in the collimator causing light flashes within the crystal corresponding to the sites of origin in the body and the amplitude of the flash is calculated by a computer to create images.

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
04260484140074MiE - Gamma Camera SystemsPICOLA-SCINTRON2022-11-29
04260484140067ANCORISANCORIS2021-06-11
04260484140029ECAT Scintron PETECAT Scintron PET2018-07-25
04260484140050SCINTRONSCINTRON2018-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859873006219Hermia OLINDAHermes Medical Solutions ABIYX2026-03-10
00810149098215R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-12-15
00810149098116R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-10-15
B843UNISYN7510UniSynConvergent Imaging Solutions IncorporatedIYX2025-08-20
00810149098000R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-07-14
00810149097966R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-05-22
00810149097928R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-03-04
00810149097799R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-02-13
00810149097836R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-02-13
00810149097843R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-02-13
00810149097737R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-01-29
00810149097713R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-01-14
00810149097706R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-01-07
00810149097683R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-12-13
00810149097690R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-12-13
00810149097638R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-11-05
00810149097621R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-11-04
00810149097607R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-10-22
00810149097584R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-10-17
00810149097546R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-09-12
00810149097522R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-09-06
00810149097409R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-08-09
00810149097287R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-06-18
00810149097270R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-04-15
00810149097263R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-03-05
00810149090073R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-01-01
00810149090141R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-01-01
00810149090158R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-01-01
00810149090196R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-01-01
00810149090202R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-01-01