Cardiovascular · 510(k) · 2024
Impala
AliveCor, Inc.. Cleared by FDA on 7 June 2024 under submission K232035, product code DPS (electrocardiograph). What FDA's record says, in FDA's words.
Device record · K232035
- Device. ImpalaDEVICE
- Company. AliveCor, Inc.COMPANY
- Decision. 7 June 2024, 510(k), substantially equivalent (traditional review); received 7 July 2023DECISION
- Panel. CardiovascularPANEL
- Product code. DPS, ElectrocardiographCODE
- Regulation. 21 CFR 870.2340, Class IIREG
- Source. FDA database entry · decision document (8 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.
Impala is intended to record, store, and transfer a 12-lead resting electrocardiogram (ECG). Impala acquires four standard diagnostic-bandwidth leads (Leads I, II, V2, V4, or Leads I, II, V1, V4). The device derives four standard diagnostic- bandwidth, Lead-III and unipolar limb leads aVR, aVF and aVL. The device also synthesizes Leads V1 or V2, V3, V5, V6, which are similar to but not identical to the same leads of a standard diagnostic 12-lead. The 4 synthesized chest leads are not intended for diagnostic use and may fail to show important findings limited to those leads. This device is not a substitute for a diagnostic 12-lead ECG and is contraindicated for use in ruling out any condition (including but not limited to certain ischemia/infarcts, Brugada syndrome) for which the diagnosis may be solely dependent on the synthesized leads. The device also provides ECG measurements and ECG analysis (rhythm and morphological interpretation) using the acquired leads. The automated ECG analysis results are provisional and should not be used for clinical action if it has not been reviewed by a qualified physician capable of independently interpreting the ECG signal in the context of the patient's condition. The automated analysis may then be confirmed, edited, or deleted by a qualified physician. ECG analysis should be used only as an adjunct to clinical history, symptoms, and the results of other non-invasive and/or invasive tests. Impala is intended for use with patients aged 18 […]
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.
- Modalities namedECG
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 898 reports filed against devices carrying product code DPS. 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. The latest reports, in the reporter’s words:
25 September 2026 · Malfunction · DECGPageWriter TC S · Philips Medizin Systeme Böblingen GmbH · report 9610816-2026-102027
25 September 2026 · Malfunction · PageWriter · Philips Medical Systems · report 1218950-2026-100667
18 September 2026 · Malfunction · Q-Stress · BAXTER HEALTHCARE CORPORATION · report 3006087789-2026-00025
Baxter received a report stating that an exam was done earlier under the wrong patient information. This occurred after patient use. There was no patient injury or death reported with this event.
16 September 2026 · Malfunction · Midmark Digital ECG Plug-In Software Version 10.2.2 · Midmark Corporation · report 1523530-2026-00012
It was reported by 15 customers that they were getting a high heart rate on the ECG. The ECG did not calculate the heart rate correctly due to multiple instances of the ECG Plug-in being opened concurrently. The doctor reviewed the results and no medication was given or harm occurred. The customers were sent the firmware update as they were on the old firmware Plug-in version.
16 September 2026 · Malfunction · Cardiac Workstation · Philips Medizin Systeme Böblingen GmbH · report 9610816-2026-101917
It was reported that the heart rate reading is inaccurate. It is unknown if the device was in use on a patient. There was no report of patient or user harm.
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 DPS, in Cardiovascular, from AliveCor, Inc., or cleared in 2024. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.