The LogicScan 64 / LogicScan 128 systems and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The applications are: cardiac (adult), fetal, abdominal, pediatric, small organ, transrectal, neonatal cephalic, peripheral vessel and musculo-skeletal (conventional and superficial). It is possible to provide diagnostic information outside of an imaging lab, including at the bedside systems, for navigated medical application, in operating rooms/critical care units.

Device Description

LogicScan 128 / LogicScan 64 color diagnostic systems are intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning. LogicScan 128 / LogicScan 64 is a combination of proprietary hardware and software that has been designed for real-time imaging and is intended to be a basic diagnostic tool. The system is based on a modular and flexible architecture allowing for both mobile and stationary (installed) configurations. The system is designed for imaging with transducer ranges of 2 to 12 MHz. The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. USB 2.0 connection between the beamformer and PC is a novel feature for ultrasound systems. The LogicScan 128 / LogicScan 64 only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the LogicScan 128 / LogicScan 64 via USB 2.0. Minimum requirements are given for the PC. The probes are connected to the LogicScan 128 / LogicScan 64. All sonograms are saved on the PC and can there be evaluated, printed and archived. The Echo Wave II software was especially designed for the LogicScan 128 / LogicScan 64. Software able to reside in a Windows-based PC. The LogicScan 128 / LogicScan 64 can be used together with the appropriate probes for the entire ultrasound diagnostic (2MHz to 12MHz probes). Two probes can work simultaneously for LogicScan 128 2Z modifications.

AI/ML Overview

This 510(k) submission for the TELEMED LogicScan 64/LogicScan 128 ultrasound systems is a predicate device comparison and does not describe an AI/ML device or present specific acceptance criteria and a study to prove performance metrics in the typical sense of AI/ML device evaluations.

Instead, the submission focuses on demonstrating substantial equivalence to already legally marketed predicate devices by showing compliance with established safety and performance standards for diagnostic ultrasound equipment. The "acceptance criteria" here are the regulatory and safety standards, and the "study" is the design and testing for compliance with these standards.

Therefore, the requested information elements related to AI/ML performance, ground truth, sample sizes for AI training/testing, expert adjudication, or MRMC studies are not applicable to this document.

Here's a breakdown of the relevant information provided in the document:

1. A table of (not applicable to AI/ML performance, but regulatory compliance):

Acceptance Criteria (Regulatory & Safety Standards)	Reported Device Performance
IEC 60601-1: 2000 (General requirements for safety)	Designed to meet these standards.
IEC 60601-1-2: 2001 (Electromagnetic compatibility)	Designed to meet these standards.
IEC 60601-1-4: 1996 (Programmable Electrical Medical Systems)	Designed to meet these standards.
IEC 60601-2-37: 2007-08 (Basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment)	Designed to meet these standards.
NEMA UD 2-2004 (Acoustic Output Measurement Standard)	Designed to meet these standards. System's acoustic output is in accordance with ALARA principle.
NEMA UD 3-2004 (Real Time Display of Thermal and Mechanical Acoustic Output Indices)	Designed to meet these standards. Has real time acoustic output display with mechanical and thermal indices.
AIUM MUS: 2002 (Medical Ultrasound Safety)	Designed to meet these standards.
ISO-10993-1, -5, -10, -11 (Biological Evaluation of Medical Devices for patient contact materials)	Patient contact materials (Silicone Rubber, ABS, PPSU) are standardized for biological evaluation.
IEC 62304: 2006 (Medical device software -- Software life cycle processes)	Designed to meet these standards; describes software architecture (hardware/firmware collecting rough data, PC running Echo Wave II software for processing).
ISO 14971:2007 (Application of risk management to medical devices)	Designed to meet these standards.
Essential Requirements of Council directive 93/42/EEC (Medical Device Directive)	Designed to meet these standards.
Substantial Equivalence to Predicate Devices (K100186, K112646)	Concluded to be safe and effective and substantially equivalent to predicate devices. No technological characteristics, features, or indications for use are novel compared to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission is based on engineering design, compliance with international standards, and comparison to predicate devices, not on a clinical performance study with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set with ground truth established by experts is described for performance evaluation in this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this submission are the established regulatory and safety standards for ultrasound devices, against which the device's design and physical properties were evaluated for compliance.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device requiring a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" to prove the device meets acceptance criteria, in this context, is the demonstration of compliance with a comprehensive set of international and national safety and performance standards for medical devices, particularly diagnostic ultrasound equipment. This includes:

Design and Engineering Compliance: The LogicScan family was designed to meet standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37, NEMA UD 2, NEMA UD 3, AIUM MUS, ISO 10993 series (for biocompatibility), IEC 62304 (for software), and ISO 14971 (for risk management).
Verification and Testing: The document states that "Prior release for manufacturing, all such devices, so designed, are tested and determined to be in full compliance with acoustic output, biocompatibility, cleaning and disinfection effectiveness." This indicates internal verification and validation testing against the specified standards.
Predicate Device Comparison: The core of a 510(k) submission for this type of device is the argument of "substantial equivalence" to legally marketed predicate devices (SAMSUNG MEDISON CO., LTD MySono U5 Diagnostic Ultrasound System K100186 and SonoAce R7 Diagnostic Ultrasound System K112646). The applicant asserts that there are "no technological characteristics or features or indications for use in this Submission that are not previously evaluated and approved in the predicate devices, nor are there such technologies, features and indications for use not commonly used in the practice of diagnostic ultrasound." This comparison serves as the primary "proof" for market clearance, rather than a novel clinical effectiveness study for a new technology.
No Additional Clinical Testing Required: The submission explicitly states, "No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices."

In conclusion, the TELEMED LogicScan 64/LogicScan 128's acceptance criteria are regulatory and safety standards, and the proof of meeting these criteria is via design for compliance, internal validation testing, and demonstration of substantial equivalence to existing, legally marketed ultrasound devices.

Summary

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Pg. 1.2-3

510(k) Summary of Safety and Effectiveness

ldentifying information 1.

JAN 2 6 2012

Manufacturer	TELEMED
Address	Dariaus ir Gireno str. 42 Vilnius LT-02189 Lithuania
Telephone	+370-5 2106272 +370-5 2106273
Fax	+370-5 2306733
E-mail	info@telemed.lt yury@telemed.lt
Contact	Yury Sokolov / Engineering Manager
Name of Device	LogicScan 64 / LogicScan 128

2. Class and Predicate Information

Classification Name	FR Number	Product Cod
Ultrasonic Pulsed Doppler Imaging System	892.1550	PIN
Ultrasonic Pulsed Echo Imaging System	892.1560	IYO
Diagnostic Ultrasonic Transducer	892.1570	ITX
Common Name	Ultrasound imaging system
Propietary Name	LogicScan
Class	Regulatory Class II
Predicate Device	SAMSUNG MEDISON CO., LTD
	MySono U5 Diagnostic Ultrasound System	K100186
	SonoAce R7 Diagnostic Ultrasound System	K112646

3. Performance Standards

The LogicScan family has been designed to meet the following:

Safety and EMC Requirements for Medical Equipment:

IEC 60601-1: 2000, Part 1: General requirements for safety.

IEC 60601-1-2: 2001, Part 1: General requirements for basic safety and essential performance, 2. Collateral standard: Electromagnetic compatibility - Requirements and tests

IEC 60601-1-2: 2001, Part 1: General requirements for basic safety and essential performance, 2.Collateral standard: Electromagnetic compatibility - Requirements and tests

IEC 60601-1-2: 2001, Part 1: General requirements for basic safety and essential performance, 2. Collateral standard: Electromagnetic compatibility - Requirements and tests

IEC 60601-1-2: 2001, Part 1: General requirements for basic safety and essential performance, 2.Collateral standard: Electromagnetic compatibility - Requirements and tests

IEC 60601-1-4: 1996, Part 1: General Requirements for Safety, 4.Collateral Standard: Programmable Electrical Medical Systems

IEC 60601-2-37: 2007-08 Particular requirements for the basic safety and essential

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performance of ultrasonic medical diagnostic and monitoring equipment

NEMA UD 2-2004: 2003. Acoustic Output Measurement Standard for Diagnostic Ultrasound Fauipment

NEMA UD 3-2004: 2004, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment

AIUM MUS: 2002, Medical Ultrasound Safety

ISO-10993-1. Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, 2003

ISO-10993-5. Biological Evaluation of Medical Devices Part 5: Tests for in vitro cytotoxicity , 1999

ISO-10993-10, Biological Evaluation of Medical Devices Part 10: Tests for irritation and delayed-type hypersensitivity, 2002

ISO-10993-11, Biological Evaluation of Medical Devices Part 11: Tests for systemic toxicity, 2006

IEC 62304: 2006 Medical device software -- Software life cycle processes

ISO 14971:2007 Medical devices -- Application of risk management to medical devices

Essential Requirements of Council directive 93/42/EEC (Medical Device Directive)

The system's acoustic output is in accordance with ALARA principle (as low as reasonably achievable)

4. Indication for Use

LogicScan 128 / LogicScan 64 ultrasound imaging systems are intended to be used for applications in cardiac (adult), fetal, abdominal, pediatric, small organ, transrectal, neonatal cephalic, peripheral vessel and musculo-skeletal (conventional and superficial). It is possible to provide diagnostic information outside of an imaging lab, including at the bedside systems, for navigated medical application, in operating rooms/critical care units.

5. Device Description

LogicScan 128 / LogicScan 64 color diagnostic systems are intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning.

LogicScan 128 / LogicScan 64 is a combination of proprietary hardware and software that has been designed for real-time imaging and is intended to be a basic diagnostic tool. The system is based on a modular and flexible architecture allowing for both mobile and stationary (installed) configurations. The system is designed for imaging with transducer ranges of 2 to 12 MHz.

The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories.

USB 2.0 connection between the beamformer and PC is a novel feature for ultrasound systems.

The LogicScan 128 / LogicScan 64 only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the LogicScan 128 / LogicScan 64 via USB 2.0. Minimum requirements are given for the PC. The probes are connected to the LogicScan 128 / LogicScan 64. All sonograms are saved on the PC and can there be evaluated, printed and archived. The Echo Wave II software was especially designed for the LogicScan 128 / LogicScan 64. Software able to reside in a Windows-based PC. The LogicScan 128 / LogicScan 64 can be used together with the appropriate probes for the entire

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ultrasound diagnostic (2MHz to 12MHz probes). Two probes can work simultaneously for LogicScan 128 2Z modifications.

Imaging Modes

B
B+B
4B
B+M
M
B+CFM/PDI/DPD1+PWD (Triplex) . HPRF(LogicScan 128)

B+PWD (Duplex)

Pulse Wave Doppler (PWD)

Directional Power Doppler (DPDI)

Color Doppler (CFM)
Power Doppler (PDI)
.
Tissue Harmonic Imaging (THI) (LogicScan 128) .
The devices included in this submission are as follows:

LogicScan 128 EXT-1Z / EXT-2Z ultrasound system utilizing as hardware and firmware an ultrasound engine contained in a small stand alone enclosure for connection to a host PC via a USB port with internal power supply:

LogicScan 128 CEXT-1Z is a compact version of LogicScan 128 EXT-1Z with internal medical grade power supply;

LogicScan 128 INT-1Z / INT-2Z ultrasound systems utilizing as hardware and firmware an ultrasound engine contained in a small enclosure for insertion to a host PC (to a drive bays);

A probe. 128 element convex array, at a central ultrasonic frequency of approximately 3.5MHz, model C3.5/60/128Z.

A probe, 128 element linear array at a central ultrasonic frequency of approximately 9 MHz, model HL9.0/40/128Z.

A probe, 128 element convex array at a central ultrasonic frequency of approximately 6.5 MHz, model PV6.5/10/128Z.

A biplane probe BiopSee, combination of:

128 element convex array at a central ultrasonic frequency of approximately . 6.5 MHz, model BIPC6.5/10/128Z
. 128 element linear array at a central ultrasonic frequency of approximately 7.5 MHz, model BIPL7.5/70/128Z

LogicScan 64 FLT-1T ultrasound system utilizing as hardware and firmware an ultrasound engine contained in a small stand alone enclosure for connection to a host PC via a USB port;

A probe, 64 element convex array, at a central ultrasonic frequency of approximately 3.5 MHz, model C3.5/60/64.

A probe, 64 element linear array at a central ultrasonic frequency of approximately 8.0 MHz, model HL9.0/40/64.

A probe, 64 element convex array at a central ultrasonic frequency of approximately 6.5 MHz, model PV6.5/10/64.

General Safety and Effectiveness 6.

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The LogicScan 128 / LogicScan 64 Ultrasound Systems are similar to currently distributed ultrasonic pulsed echo imaging systems.

There are no technological characteristics or features or indications for use in this Submission that are not previously evaluated and approved in the predicate devices, nor are there such technologies, features and indications for use not commonly used in the practice of diagnostic ultrasound.

The LogicScan Ultrasound Systems and its accessories are designed for compliance to all applicable medical devices safety standards, as referenced in DECLARATION OF CONFORMITY (Appendix 05). Prior release for manufacturing, all such devices, so designed, are tested and determined to be in full compliance with acoustic output, biocompatibility, cleaning and disinfection effectiveness. No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices in Section 1.5 Predicate Device Comparison. The LogicScan has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

7. Patient Contact Materials

The materials of probes, coming in contact with patient are:

Silicone Rubber .
Acrylonitrile Butadien Styrene (ABS)
Polyphenylsulfone (PPSU)

Standard for the biological evaluation:

ISO-10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, 2003 ISO-10993-5, Biological Evaluation of Medical Devices Part 5: Tests for in vitro cytotoxicity , 1999 ISO-10993-10, Biological Evaluation of Medical Devices Part 10: Tests for irritation and delayed-type hypersensitivity, 2002

ISO-10993-11, Biological Evaluation of Medical Devices Part 11: Tests for systemic toxicity, 2006

8. Software

The LogicScan 128 / LogicScan 64 systems contain the hardware and software which collect and pro-processes 'rough' data and send it via USB 2.0 connection to a Windows® based PC. The main application software is Echo Wave II software running on the PC, it is receiving data, processing and showing image/data on the screen. The main user interface shows an ultrasound image, controls and drop-out menus. The ultrasound images and calculated/measured data can be stored in memory.

9. Conclusion

In accordance with the FDA and based on the information provided in this Premarket notification, TELEMED concludes that the LogicScan 128 / LogicScan 64 are safe and effective and substantially equivalent to predicate devices described herein.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be an abstract caduceus or a symbol representing health and human services.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

JAN 2 6 2012

Mr. Yury Sokolov Engineering Manager TELEMED Dariaus ir Gireno str. 42 LT-02189 VILNIUS LITHUANIA

Re: K113184

Trade/Device Name: LogicScan 64/LogiScan 128 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYO, IYN, and ITX Dated: October 28, 2011 Received: October 28, 2011

Dear Mr. Sokolov:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

This determination of substantial equivalence applies to the following transducers intended for use with the DUS 6000 Digital Ultrasonic Imaging System, as described in your premarket notification:

Transducer Model Number

Probes for LogicScan 64 Convex array C3.5/60/64 Linear array HL9.0/40/64 Convex array PV6.5/10/64

Probes for LogicScan 128 Convex array C3.5/60/128Z Linear array HL9.0/40/128Z Convex array PV6.5/10/128Z BiopSee BIPC6.5/10/128 BIPL7.5/70/128

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895. 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 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): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Lauren Hefner, Ph.D. at (301) 796-6881.

Sincerely Yours.

Mary Sbotif

Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K113184

Device Name: LogicScan 64 / LogicScan 128

Indications For Use:

The LogicScan 64 / LogicScan 128 systems and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The applications are:

cardiac (adult), fetal, abdominal, pediatric, small organ, transrectal, neonatal cephalic, peripheral vessel and musculo-skeletal (conventional and superficial).

It is possible to provide diagnostic information outside of an imaging lab, including at the bedside systems, for navigated medical application, in operating rooms/critical care units.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S Pastel
(Division Sign-Off)

Office of In Vitro Diagnostic Device

Page 1 of

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1.3 Indications for Use

All indications for use of subject devices and probes are identified in the table forms:

SystemLogicScan 64		Fetal, Abdominal, Pediatric, Small Organ(Breast, Thyroid, Testicles), Neonatal Cephalic,Musculo-skeletal (Conventional), Musculo-skeletal* (Superficial), Cardiac Adult, Peripheralvessel	Table 1.3-1
	C3.5/60/64	Fetal, Abdominal, Cardiac Adult*	Table 1.3-2
Transducers	HL9.0/40/64	Pediatric,Musculo-skeletal (Conventional),Musculo-skeletal* (Superficial), Peripheral vesselSmall Organ (Breast, Thyroid, Testicles)*	Table 1.3-3
	PV6.5/10/64	Pediatric , Neonatal Cephalic, Peripheral vessel*	Table 1.3-4

SystemLogicScan 128		Fetal, Abdominal, Pediatric, Small Organ(Breast, Thyroid, Testicles), Neonatal Cephalic,Musculo-skeletal (Conventional), Musculo-skeletal* (Superficial), Cardiac Adult, Peripheralvessel	Table 1.3-5
	C3.5/60/128Z	Fetal, Abdominal, Cardiac Adult*	Table 1.3-6
Transducers	HL9.0/40/128Z	Pediatric,Musculo-skeletal (Conventional),Musculo-skeletal* (Superficial), Peripheralvessel, Small Organ (Breast, Thyroid, Testicles)	Table 1.3-7
	PV6.5/10/128Z	Pediatric , Neonatal Cephalic, Peripheral vessel*	Table 1.3-8
	BIPC6.5/10/128ZBIPL7.5/70/128Z	Transrectal, Intraoperative (include NeedleGuidance)	Table 1.3-9

*Including Imaging for needle guidance

Mary Pastel

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K113/84

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Diagnostic Ultrasound Indications for Use Form

LogicScan 64 System:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Table 1.3-1 ·

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(specify)	Other(specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	Note 1	Note 2,3
	Abdominal	N	N	N	N	N	Note 1	Note 2,3
	Intraoperative (specify)
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	Note 1	Note 2,3
	Small Organ (specify)	N	N	N	N	N	Note 1	Note 2,3
	Neonatal Cephalic	N	N	N	N	N	Note 1	Note 2,3
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (Non-Card)
	Musculo-skeletal(Conventional)	N	N	N	N	N	Note 1	Note 2,3
	Musculo-skeletal(Superficial)	N	N	N	N	N	Note 1	Note 2,3
	Intravascular
	Other (specify)
	Cardiac Adult	N	N	N	N	N	Note 1	Note 2,3
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel	N	N	N	N	N	Note 1	Note 2,3
	Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Note 1 - Combined Modes: Color+B, Power+B,

Note 2 - Includes Imaging for Needle Guidance

Note 3 - Small Organs (specifically Breast, Thyroid, Testicles)

Note 4 - Tissue harmonic Imaging (THI)

Note 5 - Intraoperative applications: Include Needle Guidance

Mary Spostel

(Division Sign-Off Division of Radiological Devic Office of In Vitro Evaluation and Safety

510K. K113.184

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Diagnostic Ultrasound Indications for Use Form

LogicScan 64 System:

Convex array C3.5/60/64

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Transducer:

Table 1.3-6
Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(specify)	Other(specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	Note 1	Note 2,3
	Abdominal	N	N	N		N	Note 1	Note 2,3
	Intraoperative (specify)
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (Non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal.(Superficial)
	Intravascular
	Other (specify)
	Cardiac Adult	N	N	N		N	Note 1	Note 2,3
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Note 1 - Combined Modes: Color+B, Power+B,

Note 2 - Includes Imaging for Needle Guidance

Note 3 - Small Organs (specifically Breast, Thyroid, Testicles)

Note 4 - Tissue harmonic Imaging (THI)

Note 5 - Intraoperative applications: Include Needle Guidance

Mary S Patil
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K.

Table 1.3-2

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Diagnostic Ultrasound Indications for Use Form

LogicScan 64 System:

Linear array HL9.0/40/64 Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Table 1.3-3

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(specify)	Other(specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intraoperative (specify)
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	Note 1	Note 2,3
	Small Organ (specify)	N	N	N		N	Note 1	Note 2,3
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (Non-Card)
	Musculo-skeletal(Conventional)	N	N	N		N	Note 1	Note 2,3
	Musculo-skeletal(Superficial)	N	N	N		N	Note 1	Note 2,3
	Intravascular
	Other (specify)
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel	N	N	N		N	Note 1	Note 2,3
	Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Note 1 - Combined Modes: Color+B, Power+B,

Note 2 - Includes Imaging for Needle Guidance

Note 3 - Small Organs (specifically Breast, Thyroid, Testicles)

Note 4 - Tissue harmonic Imaging (THI)

Note 5 - Intraoperative applications: Include Needle Guidance

Mary S Patel
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evanuance and Satery

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Diagnostic Ultrasound Indications for Use Form

LogicScan 64 System:

Convex array PV6.5/10/64 Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Table 1.3-4
Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(specify)	Other(specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intraoperative (specify)
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	Note 1	Note 2,3
	Small Organ (specify)
Fetal Imaging& Other	Neonatal Cephalic	N	N	N		N	Note 1	Note 2,3
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (Non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (specify)
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel	N	N	N		N	Note 1	Note 2,3
	Other (specify)

. N= new indication; P= previously cleared by FDA; E= added under Appendix E

Note 1 Combined Modes: Color+B, Power+B,
Note 2 Includes Imaging for Needle Guidance
Note 3 Small Organs (specifically Breast, Thyroid, Testicles)

Note 4 - Tissue harmonic Imaging (THI)

Note 5 Intraoperative applications: Include Needle Guidance
Mary S/astel
(Division Sign-Off)

510

Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation anc Sarety

{12}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

Table 1.3-5

System: LogicScan 128

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(specify)	Other(specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	Note 1	Note 2,3,4
	Abdominal	N	N	N		N	Note 1	Note 2,3,4
	Intraoperative (specify)	N				N	Note 1	Note 2,5
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	Note 1	Note 2,3,4
	Small Organ (specify)	N	N	N		N	Note 1	Note 2,3,4
	Neonatal Cephalic	N	N	N		N	Note 1	Note 2,3,4
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal	N				N	Note 1	Note 2,5
	Trans-vaginal
	Trans-urethrai
	Trans-esoph. (Non-Card)
	Musculo-skeletal(Conventional)	N	N	N		N	Note 1	Note 2,3,4
	Musculo-skeletal(Superficial)	N	N	N		N	Note 1	Note 2,3,4
	Intravascular
	Other (specify)
	Cardiac Adult	N	N	N		N	Note 1	Note 2,3,4
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral .Vessel	Peripheral vessel	N	N	N		N	Note 1	Note 2,3,4
	Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Note 1 - Combined Modes: Color+B, Power+B,

Note 2 - Includes Imaging for Needle Guidance

Note 3 - Small Organs (specifically Breast, Thyroid, Testicles)

Note 4 - Tissue harmonic Imaging (THI)

Note 5 - Intraoperative applications: Include Needle Guidance

Mary S. Patel
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K113184

{13}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

System: LogicScan 128 Transducer:

Convex array C3.5/60/128Z

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Table 1.3-6
Clinical Application						Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(specify)	Other(specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	Note 1	Note 2,3,4
	Abdominal	N	N	N		N	Note 1	Note 2,3,4
	Intraoperative (specify)
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (specify)№
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (Non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (specify)
Cardiac	Cardiac Adult	N	N	N		N	Note 1	Note 2,3,4
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Note 1 - Combined Modes: Color+B, Power+B,

Note 2 - Includes Imaging for Needle Guidance

Note 3 - Small Organs (specifically Breast, Thyroid, Testicles)

Note 4 - Tissue harmonic Imaging (THI)

Note 5 - Intraoperative applications: Include Needle Guidance

Man S Patel
(Division Sign-Off)

DIVISION
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K: K113184

{14}------------------------------------------------

510(k) Premarket Submission

Pg. 1.3-8

Diagnostic Ultrasound Indications for Use Form

LogicScan 128 System:

Transducer: Linear array HL9.0/40/128Z

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Tahlo

ויטיו ביתריו במוספוClinical Application		Mode of Operation
General	Specific					Color	Combined	Other
(Track 1 Only)	(Track 1 & 3)	B	M	PWD	CWD	Doppler	(specify)	(specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intraoperative (specify)
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N.	Note 1	Note 2,3,4
	Small Organ (specify)	N	N	N		N	Note 1	Note 2,3,4
	Neonatal Cephalic
Fetal Imaging	Adult Cephalic
& Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (Non-Card)
	Musculo-skeletal(Conventional)	N	N	N		N	Note 1	Note 2,3,4
	Musculo-skeletai(Superficial)	N	N	N		N	Note 1	Note 2,3,4
	Intravascular
	Other (specify)
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel	N	N	N		N	Note 1	Note 2,3,4
Vessel	Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Note 1 - Combined Modes: Color+B, Power+B,

Note 2 - Includes Imaging for Needle Guidance

Note 3 - Small Organs (specifically Breast, Thyroid, Testicles)

Note 4 - Tissue harmonic Imaging (THI)

Note 5 - Intraoperative applications: Include Needle Guidance

Mary S Patil
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

૧૮૮૮૪

{15}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

System: LogicScan 128 Transducer:

Convex array PV6.5/10/128Z

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Table 1.3-8

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(specify)	Other(specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intraoperative (specify)
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	Note 1	Note 2,3,4
	Small Organ (specify)
	Neonatal Cephalic	N	N	N		N	Note 1	Note 2,3,4
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (Non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (specify)
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
	PeripheralVessel	Peripheral vessel	N	N	N		N	Note 1
Other (specify)

· N= new indication; P= previously cleared by FDA; E= added under Appendix E

Note 1 - Combined Modes: Color+B, Power+B,

Note 2 - Includes Imaging for Needle Guidance

Note 3 - Small Organs (specifically Breast, Thyroid, Testicles)

Note 4 - Tissue harmonic Imaging (THI)

Note 5 - Intraoperative applications: Include Needle Guidance

Mary S. Patel
Division Sign-Off)

Division of Radiological Devices vice Evaluation and Safety Office of In Vitro Diagn

Office of In Vitro Diagnostic Device Evaluation and Se
810K. K113184

{16}------------------------------------------------

510(k) Premarket Submission

LogicScan Diagnostic Ultrasound System

Pg. 1.3-10

Diagnostic Ultrasound Indications for Use Form

System:

Logic Scan 128

Transducer:

BiopSee BIPC6.5/10/128 BIPL7.5/70/128

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Table 1.3-9 ·

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(specify)	Other(specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal
	Intraoperative (specify)	N				N	Note 1	Note 2,5
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N				N	Note 1	Note 2,5
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (Non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Note 1 Combined Modes: Color+B, Power+B,
Note 2 Includes Imaging for Needle Guidance
Note 3 Small Organs (specifically Breast, Thyroid, Testicles)

Note 4 - Tissue harmonic Imaging (THI)

Note 5 - Intraoperative applications: Include Needle Guidance

Mary S. Pastel

Division valuation and Safety Office of In Vitro Diagnostic Device

SIOK

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.