Cardiovascular · 510(k) · 2023
SignalHF (IM008)
Implicity Inc.. Cleared by FDA on 25 October 2023 under submission K230842, product code QNL (medium-term adjunctive predictive cardiovascular indicator). What FDA's record says, in FDA's words.
Device record · K230842
- Device. SignalHF (IM008)DEVICE
- Company. Implicity Inc.COMPANY
- Decision. 25 October 2023, 510(k), substantially equivalent (traditional review); received 28 March 2023DECISION
- Panel. CardiovascularPANEL
- Product code. QNL, Medium-Term Adjunctive Predictive Cardiovascular IndicatorCODE
- Regulation. 21 CFR 870.2210, Class IIREG
- Source. FDA database entry · decision document (15 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The SignalHF System is intended for use by qualified healthcare professionals (HCP) managing patients over 18 years old who are receiving physiological monitoring for Heart Failure surveillance and implanted with a compatible Cardiac Implantable Electronic Devices (CIED) (i.e., compatible pacemakers, ICDs, and CRTs). The SignalHF System provides additive information to use in conjunction with standard clinical evaluation. The SignalHF HF Score is intended to calculate the risk of HF for a patient in the next 30 days. This System is intended for adjunctive use with other physiological vital signs and patient symptoms and information and is not intended to independently direct therapy.
The product code's definition, from FDA's classification record. The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events within a defined medium-term period. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QNL. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QNL, in Cardiovascular, from Implicity Inc., or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
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