It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analyzing data recorded in the compatible formats from dedicated ambulatory ECG devices such as Holter, event recorder, Mobile Cardiac Telemetry or other similar devices when tof the rhythm is necessary. The product can be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAI can be integrated into medical devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.

DeepRhythmAI is not for use in life-supporting or sustaining systems or ECG Alarm devices. Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms and other diagnostic information.

Device Description

The DeepRhythmAl is a cloud-based software for automated analysis of ECG data. It uses a scalable Application Programming Interface (API) to enable easy integration with other medical products. The main component of DeepRhythmAl is an automated proprietary deep-learning algorithm, which measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review.

DeepRhythmAl can be integrated into medical devices. The product supports downloading and analyzing data recorded in the compatible formats from dedicated ambulatory ECG devices such as Holter, event recorder, Mobile Cardiac Telemetry or other similar devices when the assessment of the rhythm is necessary. DeepRhythmAI can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAl doesn't have a User Interface therefore it should be integrated with the external visualization software used by the ECG technicians for the ECG visualization and analysis reporting.

It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result. .

DeepRhythmAI algorithm detects cardiac beats/arrythmias and intervals including:

. QRS
Heart rate determination
RR Interval measurements
Non-paced arrhythmias
Non-paced ventricular arrhythmia calls
Ventricular ectopic beats
Supraventricular ectopic beats

DeepRhythmAl returns the interpretation result to be reviewed by a qualified healthcare professional. DeepRhythmAl when integrated with the other computer-based ECG systems, creates a semi-autonomous system for analysis of ECG recordings. All algorithm annotations must be analyzed and confirmed by a qualified healthcare professional. The subject device can only be integrated with the display product used by the monitoring center that allows for verification of the algorithm output, its correction and confirmation.

DeepRhythmAl is not for use in life-supporting or sustaining systems or ECG Alarm devices. Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms and other diagnostic information.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the DeepRhythmAI device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance for specific metrics (e.g., sensitivity, specificity for arrhythmia detection) as one might find in a detailed clinical performance study report. Instead, it states that the device was subjected to performance testing according to recognized consensus standards.

Acceptance Criteria (Implicit from Standards and General Statements):

Performance Aspect	Standard / Requirement	Acceptance Indication
Arrhythmia detection and classification	ANSI/AAMI/IEC 60601-2-47:2012/(R)2016	Device meets intended use; substantially equivalent to predicates.
Software development and validation	ANSI/AAMI/IEC 62304 & FDA "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" (January, 2002)	Confirmed through performance testing.
Electrical safety and EMC (implied)	ANSI/AAMI/IEC 60601-2-47:2012/(R)2016	Implied by adherence to standard.
Functional performance	Test results confirm DeepRhythmAI meets its intended use.	Device performs as intended for cardiac arrhythmia assessment.

Reported Device Performance:

The document states that "All necessary testing was conducted on the DeepRhythmAl to support a determination of substantial equivalence to the predicate and reference devices. Test results confirm that DeepRhythmAl meets its intended use." However, specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, positive predictive value, negative predictive value for different arrhythmias) are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It only mentions that performance testing was conducted according to specific standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth for any test set.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed or any effect size of human readers improving with AI vs. without AI assistance. The device is explicitly stated to not be for standalone diagnosis and requires review by a qualified healthcare professional.

6. Standalone (Algorithm Only) Performance Study

The document states: "All algorithm annotations must be analyzed and confirmed by a qualified healthcare professional." and "Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only..." These statements strongly suggest that the device is not intended or validated for standalone performance. Its integration with human review is a fundamental aspect of its intended use.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data, etc.) for its performance testing. Given its function, it is highly probable that expert-annotated ECG data would be used, but this is not confirmed in the provided text.

8. Sample Size for the Training Set

The document does not provide details on the sample size used for the training set for the DeepRhythmAI's deep-learning algorithm.

9. How the Ground Truth for the Training Set Was Established

The document does not provide details on how the ground truth for the training set was established.

Summary

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July 27, 2022

Medicalgorithmics S.A. % Agnieszka Romowicz Operations & Product Compliance Director Medicalgorithmics US Holding Corporation 2711 Centerville Road, Suite 400 Wilmington, DE 19808

Re: K210822

Trade/Device Name: DeepRhythmAI Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, DPS Dated: June 24, 2022 Received: June 27, 2022

Dear Agnieszka Romowicz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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542 of the Act); 21 CFR 1000-1050.

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210822

Device Name DeepRhythmAI

Indications for Use (Describe)

DeepRhythmAI is a cloud-based software for the assessment of cardiac arrhythmias using two lead ECG data in adult patients.

Type of Use (Select one or both, as applicable)
✓ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

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June 24, 2022

510(k) Summary

2022-06-24

l. Submitter's name and address:

Medicalgorithmics S.A. Aleje Jerozolimskie 81, 02-001 Warsaw, Poland

Contact Person: Agnieszka Romowicz Phone: (+48) 733 888 448 Email: a.romowicz@medicalgorithmics.com

Date Prepared:

ll. Device

Trade name:	DeepRhythmAl
Common name:	ECG Analysis System
Classification name:	Programmable Diagnostic ComputerElectrocardiograph
Regulation number:	870.1425870.2340
Regulatory Class:	Class II
Classification Product code:	DQK, DPS

lll. Substantial Equivalence

The selected predicate and reference devices are:

1. RhythmAnalytics, K182344 (Predicate Device),
1. Zio AT ECG Monitoring System, K181502 (Reference Device).

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Device description IV.

It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result. .

DeepRhythmAI algorithm detects cardiac beats/arrythmias and intervals including:

. QRS
Heart rate determination
RR Interval measurements
Non-paced arrhythmias
Non-paced ventricular arrhythmia calls
Ventricular ectopic beats
Supraventricular ectopic beats

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Indications for use V.

DeepRhythmAl is a cloud-based software for the assessment of cardiac arrhythmias using two lead ECG data in adult patients.

The product can be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAl can be integrated into medical devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.

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Image /page/6/Picture/0 description: The image is a logo for Medical Algorithms. The logo has the word "MEDICAL" in gray and the word "ALGORITHMS" in red. Below the words is the phrase "INNOVATIVE SOLUTIONS IN MEDICINE" in gray.

Comparison to predicate device VI.

The following tables provide a comparison of the detection features and device comparison of DeepRhythmAI and the predicate devices.

Detection Features comparison:

Device functionality	DeepRhythmAl	RhythmAnalytics	Zio AT ECGMonitoring System
QRS detection	YES	YES	No information
Heart rate determination fornon-paced adult	YES	YES	YES
R-R interval detection	YES	YES	No information
Non-paced arrhythmiasinterpretation	YES	YES	YES
Non-paced ventriculararrhythmias calls	YES	YES	YES
Atrial fibrillation detection	YES	No information	YES
Cardiac beats detection(Ventricular ectopic beats,Supraventricular ectopicbeats)	YES	YES(Ventricular ectopicbeats)	YES
Patient populations	Adult	Min 18 years old	Min 18 years old

Device comparison:

Devicefunctionality	Subject device	Predicate device	Reference device
	DeepRhythmAl	RhythmAnalytics	Zio AT ECG MonitoringSystem
Manufacturer	Medicalgorithmics S.A.	Biofourmis SingaporePte. Ltd.	iRhythm Technologies, Inc.
510(k) Number	K210822	K182344	K181502
Classification	Class II	Class II	Class II
RegulationNumber(s)	21 CFR §870.142521 CFR §870.2340	21 CFR §870.142521 CFR §870.2340	21 CFR §870.142521 CFR §870.280021 CFR §870.292021 CFR §870.1025
Devicefunctionality	Subject device	Predicate device	Reference device
	DeepRhythmAl	RhythmAnalytics	Zio AT ECG MonitoringSystem
Classificationname	ProgrammableDiagnostic Computer,Electrocardiograph	ProgrammableDiagnostic Computer,Electrocardiograph	ProgrammableDiagnostic Computer;
			Medical Magnetic TapeRecorder;
			Telephoneelectrocardiographtransmitter and receiver;
			Arrhythmia detector andalarm
Product Code	DQK, DPS	DQK, DPS	DQK, DSH, DXH, DSI
Indications forUse	DeepRhythmAl is acloud-based software forthe assessment ofcardiac arrhythmiasusing two lead ECG datain adult patients.It is intended for use bya healthcare solutionintegrator to build web,mobile or another typesof applications to letqualified healthcareprofessionals review andconfirm the analyticresult. The productsupports downloadingand analyzing datarecorded in thecompatible formats fromdedicated ambulatoryECG devices such asHolter, event recorder,Mobile CardiacTelemetry or othersimilar devices when theassessment of therhythm is necessary.The product can beelectronically interfacedand perform analysiswith data transferredfrom other computer-based ECG systems,such as an ECGmanagement system.DeepRhythmAl can beintegrated into medical	RhythmAnalytics is asoftware application forthe assessment ofcardiac arrhythmiasusing single-lead ECGdata in subjects over 18years of age. It isintended for use by ahealthcare solutionintegrator to build web ormobile applications to letqualified healthcareprofessionals review andconfirm the analyticresult. The productsupports downloadingand analyzing datarecorded in compatibleformats from any FDAcleared device used forthe arrhythmiadiagnostics such asHolter, event recorder,or other similar deviceswhen assessment of therhythm is necessary.RhythmAnalytics canalso be electronicallyinterfaced, and performanalysis with datatransferred from othercomputer based ECGsystems, such as anECG managementsystem.RhythmAnalyticsprovides ECG signal	The device is intendedto capture, analyze andreport symptomatic andasymptomatic cardiacevents and continuouselectrocardiograminformation for long-termmonitoring. Whilecontinuously recordingpatient ECG, bothpatient triggered andautomatically-detectedarrhythmia events aretransmitted to amonitoring center forreporting. After wear, afinal report is generatedbased on the beat-to-beat information fromthe entire ECGrecording. It is indicatedfor use on patients 18years or older who maybe asymptomatic or whomay suffer from transientsymptoms such aspalpitations, shortness ofbreath, dizziness, light-headedness, pre-syncope, syncope,fatigue, or anxiety andpatients who areasymptomatic. Thereports are provided forreview by the intendeduser to render adiagnosis based on
Devicefunctionality	Subject device	Predicate device	Reference device
	DeepRhythmAl	RhythmAnalytics	Zio AT ECG MonitoringSystem
	devices. In this case, themedical devicemanufacturer will identifythe indication for usedepending on theapplication of theirdevice.DeepRhythmAl is not foruse in life-supporting orsustaining systems orECG Alarm devices.Interpretation results arenot intended to be thesole means of diagnosis.It is offered to physiciansand clinicians on anadvisory basis only inconjunction with thephysician's knowledge ofECG patterns, patientbackground, clinicalhistory, symptoms andother diagnosticinformation.	processing and analysis,QRS and VentricularEctopic Beat detection,QRS feature extraction,interval measurement,heart rate measurement,and rhythm analysis.RhythmAnalytics is notfor use in life supportingor sustaining systems orECG monitor and Alarmdevices. The productcan be integrated intomedical devices. In thiscase, the medical devicemanufacturer will identifythe indication for usedepending on theapplication of theirdevice. RhythmAnalyticsinterpretation results arenot intended to be thesole means of diagnosis.Itis offered to physiciansand clinicians on anadvisory basis only inconjunction with thephysician's knowledge ofECG patterns, patientbackground, clinicalhistory, symptoms, andother diagnosticinformation.	clinical judgment andexperience. It is notintended for use oncritical care patients.
Level of Concern	Moderate	Major	No information
Components	Software only:1) A web API2) An automatedproprietary algorithm.	Software only:1) A web API2) An automatedproprietary algorithm.	1) Zio AT PatchRecorder Device2) Zio AT WirelessGateway Device withBluetooth and CellularTechnology3) ZEUS System foranalysis and reporting.
Interface	Web applicationprogramming interface(API)	Web applicationprogramming interface(API)	PC / Server Mix toClinician & PatientWebsites
Part responsiblefor ECG signalanalysis	The automatedproprietary deep-learning algorithm, which	The automatedproprietary algorithm,i.e., cardiacbeats/arrhythmias	The ZEUS System(component of the ZioAT ECG MonitoringSystem)
Devicefunctionality	Subject device	Predicate device	Reference device
	DeepRhythmAl	RhythmAnalytics	Zio AT ECG MonitoringSystem
ECG data to providequalified healthcareprofessional withsupportive informationfor review.	detection whichmeasures and analyzesECG data to providequalified healthcareprofessional supportiveinformation for review.	electrocardiogram(ECG) analysis andreporting software,designed to processcontinuously recordedsingle-lead ECG data.The ZEUS Softwaredownloads, stores,analyzes and sorts theECG data to allowiRhythm's CertifiedCardiographicTechnicians (CCTs) togenerate and distribute areport of the findingscontained within thedata, thereby enablingthe provision of acomplete ECGprocessing and analysisservice. The ZEUSSoftware contains arhythm classificationalgorithm utilizing deep-learning technology.
Number of leadsfor a receivedECG signal	two lead ECG data	single-lead ECG data	single-lead ECG data
Display orGraphical UserInterface (GUI)	No primary display orGUI	No primary display, ithas a GUI	Has display and GUI

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Device comparison summary:

Similarities: -
- 1. The subject device, predicate and reference devices have the same fundamental scientific technology and intended use.
- 1. The subject device, predicate and reference devices analyze ECG signals, detect and classify arrhythmias for compatible formats from FDA -cleared devices.
- 1. The subject device and predicate device are software only with callable Application Programming Interface (API) used for interaction with clients.
- 1. The subject device and the predicate device are not for use in patients requiring life-supporting or life-sustaining systems or ECG Alarm devices.
- 1. The subject device and the predicate device provide arrhythmia analysis that are not intended to be the sole means of diagnosis. In both devices, the ECG analytics results are returned to be reviewed and interpreted by a physician or other qualified healthcare professional to make a diagnosis.
- 1. The subject device, predicate and reference devices have the same patient population.
Differences: -
- 1. The predicate and reference devices have Graphical User Interface (GUI), while DeepRhythmAl doesn't have GUI. This is minor difference, and it does not impact either safety or effectiveness of the product. Analysis results are made available for the user through GUI of the third-party software integrated with DeepRhythmAl, but it does not cause neither safety nor effectiveness impact. GUI just makes it easier for users.
- 1. The predicate device and reference device have different Levels of Concern . The Level of Concern of the subject device has been determined according to the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medica Devices, May 11, 2005

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Summary of performance data VII.

The DeepRhythmAl software for arrhythmia detection and automated analysis of ECG data has been subjected to performance testing according to the recognized consensus standards, ANSI/AAMI/IEC 60601-2-47:2012/(R)2016 and AAMI/ANSI/EC57:2012.

Medicalgorithmics followed ANSI/AAMI/IEC 62304 and the FDA Guidance Document, "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" (January, 2002) with respect to software development and validation.

All necessary testing was conducted on the DeepRhythmAl to support a determination of substantial equivalence to the predicate and reference devices. Test results confirm that DeepRhythmAl meets its intended use.

VIII. Conclusion

The Medicalgorithmics' DeepRhythmAl is substantially equivalent to the predicate and reference devices as supported by the descriptive information and the performance testing. The subject device complies with all applicable FDA requirements, recognized standards and guidance documents. Any differences consensus in technological characteristics have been analyzed and addressed through performance testing that demonstrated that the DeepRhythmAl meets its intended use and that any differences between the subject device and the predicate and reference devices do not raise any new issues of safety or effectiveness.

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).