FDA.reportPublic FDA data

MAMMI

Primary DI
08437018413034
Brand
MAMMI
Company
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
Model
MAMMI SR
Catalog number
FP-0202
Device description
MAMMI is a Positron Emission Tomography (PET) system for medical imaging applications and for measuring the distribution of positron-emitting radiodrugs administered to patients to detect breast cancer. The system MAMMI presents two modalities:- Breast PET Mammography System with a single ring (SR) detector and a prone examination bed (this record).- Breast PET Mammography System with a double ring (DR) detector and a prone examination bed.
Published
2022-01-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K161631000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161631000MAMMIGeneral Equipment For Medical Imaging2016-07-28KPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08437018413034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437018413034084370184130348437018413034

GMDN Terms#

Term, Definition table
TermDefinition
PET systemAn assembly of devices comprising a diagnostic, positron emission tomography (PET) imaging system used to detect, record, quantify and analyse 511 kilo-electronvolt (keV) photon emission patterns resulting from annihilation reactions produced during the decay of positron emitting radiopharmaceuticals. It produces three-dimensional (3-D) tomographic digital cross-sectional physiological images representing distribution patterns of positron emitting radiopharmaceuticals ingested by, or injected into the patient. It typically uses lead collimators and specialized software for image reconstruction allowing mapping of metabolic patterns and rates associated with targeted physiological processes.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height1480Millimeter
Length1430Millimeter
Weight154Kilogram
Width661Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature-15 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
463337670
Device count
1
DM exempt
true
Combination product
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08437018413188CAREMIBRAINFP-0600FP-06002024-05-28
08437018413294GAMMAPROANGLEDIC-11802023-01-18
08437018413072WPROBESTDIC-11502021-12-01
08437018413089WPROBELAPIC-11702021-12-01
08437018413096WPROBEHI-SIC-11602021-12-01
08437018413010SENTINELLASENTINELLA 102FP-00402022-01-14
08437018413027SENTINELLASENTINELLA 102 HORUSFP-00552022-01-14
08437018413041MAMMIMAMMI DRFP-02032022-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00198953061329NMCT 860G E MEDICAL SYSTEMS ISRAEL LTD.KPS2025-09-09
00198953061336NMCT 850G E MEDICAL SYSTEMS ISRAEL LTD.KPS2025-09-09
04068151048063Biograph Trinion.X EP9 CT128SIEMENS MEDICAL SOLUTIONS USA, INC.KPS2025-08-28
B133NEUROQ412507140NeuroQSYNTERMED INCORPORATEDKPS2025-08-06
06971576832033uMIShanghai United Imaging Healthcare Co., Ltd.KPS2025-08-03
06971576832163uMIShanghai United Imaging Healthcare Co., Ltd.KPS2025-08-03
06971576832231uMIShanghai United Imaging Healthcare Co., Ltd.KPS2025-08-03
06971576832255uMIShanghai United Imaging Healthcare Co., Ltd.KPS2025-08-03
B133ECTB4225063000Emory Cardiac ToolboxSYNTERMED INCORPORATEDKPS2025-08-01