FDA.reportPublic FDA data

SignalHF

Primary DI
03770025266015
Brand
SignalHF
Company
Implicity Inc.
Model
V1.0.2
Published
2024-04-16
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
QNLMedium-Term Adjunctive Predictive Cardiovascular Indicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QNLMedium-Term Adjunctive Predictive Cardiovascular IndicatorCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230842000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230842000SignalHF (IM008)Implicity, Inc.2023-10-25QNL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03770025266015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770025266015037700252660153770025266015

GMDN Terms#

Term, Definition table
TermDefinition
Cardiology information system application softwareAn application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of cardiology services and facilities. It is typically supplied for installation into a dedicated information system for cardiology or existing mainframe or decentralized computers/networks.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118346169
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770025266008ILR ECG AnalyzerV1.1.4IM0072024-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00690103219616ForeSight IQEdwards Lifesciences LLCQNL2025-07-11
00690103217711Acumen AFM™ cable - HemoSphere Alta™ monitorEdwards Lifesciences LLCQNL2025-07-11
00690103217728HemoSphereEdwards Lifesciences LLCQNL2025-07-11
00690103217957HemoSphere AltaEdwards Lifesciences LLCQNL2025-03-13
00690103217964HemoSphere AltaEdwards Lifesciences LLCQNL2025-03-13
00690103217971HemoSphere AltaEdwards Lifesciences LLCQNL2025-03-13
07290018852002CLEWICUCLEW MEDICAL LTDQNL2024-12-09
B823AHIV200AHI SystemFifth Eye, Inc.QNL2022-02-12