smart-sync

Primary DI
04260675390028
Brand
smart-sync
Company
northh medical GmbH
Model
P01-SB-01-03
Catalog number
P01-SB-01
Device description
smart-sync is an MRI-compatible Doppler ultrasound system that determines the cardiac cycle of patients and synchronizes it with the MRI imaging. smart-sync can be used for the synchronization of the heartbeat both for fetuses and adults.The heartbeat of the patient is detected by positioning an ultrasound sensor above the patient’s heart. The ultrasound sensor is fixated with a flexible belt. The reflection of Doppler ultrasound signals is analyzed, and a trigger signal is derived for every heartbeat. smart-sync sends the Doppler ultrasound signal and the trigger signal (synchronization signal) to the MRI scanner utilizing a wireless connection.
Published
2024-06-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212271000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212271000smart-syncNorthh Medical GmbH2022-02-04LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260675390028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260675390028042606753900284260675390028

GMDN Terms#

Term, Definition table
TermDefinition
MRI system synchronizerA physiological monitoring unit used as a component of a diagnostic magnetic resonance imaging (MRI) system, that produces a signal which enables image formation or data collection to be synchronized with a specific measurable physiological parameter, e.g., the beginning of a patient's respiratory or cardiac cycle. It is primarily used for the purpose of artifact reduction or enhancement of signal-to-noise ratios in various real-time or dynamic MRI applications. It is sometimes referred to as a gated imaging accessory or trigger.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+494023969451support@northh.de

Regulatory Flags#

DUNS number
314359601
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260675390042smart-syncP01-SB-01 (LOT: 6)P01-SB-012026-04-14
04260675390035smart-syncP01-SB-01 (LOT: 5)P01-SB-012025-07-29
04260675390011smart-syncP01-SB-01-02P01-SB-012022-02-24

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