S8 DIAGNOSTIC ULTRASOUND SYSTEM

• K Number: K112451
• Device Name: S8 DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer: SONOSCAPE COMPANY LIMITED
• Date Cleared: 2011-09-16 ( 22 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Special
• Panel: Radiology
• Age Range: All
• Reference & Predicate Devices: K092922
• Predicate For: N/A

Intended Use

The SonoScape S8 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, OB/Gyn and Urology. This is the same intended use as previously cleared for the SonoScape S8 Diagnostic Ultrasound System, K092922.

Device Description

The SonoScape S8 Ultrasound System, previously cleared under K092922, is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The only modifications that were made are: The original S8 Diagnostic Ultrasound System, was previously cleared in K092922 dated March 12, 2009, uses an internal SMPS as its power supply system. And the proposed device was redesigned, changing from AC to battery power, i.e. the internal Li-ion Battery Pack (with an external AC adapter). Such a change is accompanied by labeling changes, but not including new indication for use.

AI/ML Overview

The SonoScape S8 Diagnostic Ultrasound System (K112451) is a re-submission of a previously cleared device (K092922) with modifications. The primary modification is the change in the power supply system from an internal SMPS to an internal Li-ion Battery Pack with an external AC adapter. This submission does not introduce new indications for use.

Based on the provided information, the acceptance criteria and study details are primarily focused on safety and substantial equivalence to the predicate device, rather than a clinical performance study with specific diagnostic accuracy metrics.

Here's an analysis of the provided document points:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) for a given clinical task. Instead, it relies on demonstrating substantial equivalence to a predicate device and adherence to recognized safety and performance standards.

The "reported device performance" referenced here relates to its conformity with safety standards and its functionality as a diagnostic ultrasound system, rather than clinical efficacy metrics.

Acceptance Criteria Category	Specific Standard/Requirement	Reported Device Performance
Safety	- IEC 60601-1: Medical Electrical Equipment - General Requirements for Safety (1988; Amdt 1, 1991-11; Amdt 2, 1995)	Device found to conform to applicable medical device safety standards in regards to thermal, mechanical, and electrical safety.
	- IEC 60601-1-2: Electromagnetic Compatibility - Requirements and Tests (2001)	Device found to conform to applicable medical device safety standards.
	- IEC 60601-2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (2004, Amdt 2, 2005)	Device found to conform to applicable medical device safety standards.
Acoustic Output	- NEMA UD 2: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (2004)	Acoustic output measured and calculated according to NEMA UD 2: 2004 and NEMA UD3: 2004 (for real-time display of thermal and mechanical acoustic output indices). The device was tested as a Track 3 Device per FDA Guidance.
Biocompatibility	- ISO 10993-5: Biological evaluation of medical devices - Tests for In Vitro cytotoxicity (1999)	Device found to conform to applicable medical device safety standards, including biocompatibility.
	- ISO 10993-10: Biological evaluation of medical devices - Tests for irritation and delayed-type hypersensitivity (2002)	Device found to conform to applicable medical device safety standards, including biocompatibility.
Functional Equivalence	Functionality of the power supply system (comparison to predicate device's SMPS)	The redesigned power supply system (Li-ion Battery Pack and AC Adapter) performs the same function of converting mains voltage/charging battery and supplying required DC voltages to the system's electronic parts. It also controls LED indicators. (This demonstrates functional equivalence in power delivery).
Intended Use	Same as predicate device (K092922)	The intended use for evaluating Abdomen, Cardiac, Small Organ, Peripheral Vascular, Musculo-skeletal, Pediatric, Fetal, Cephalic, OB/Gyn and Urology is the same as the previously cleared S8 Diagnostic Ultrasound System, K092922.

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

The submission describes "Laboratory testing was conducted to verify that the S8 Diagnostic Ultrasound System met all design specification and was substantially equivalent to the currently marketed Predicate Device." This implies engineering and performance verification testing against technical specifications and safety standards, rather than a clinical study with a "test set" of patient data.

• Sample Size for Test Set: Not applicable in the context of clinical data for diagnostic performance. The "test set" here refers to the device and its components undergoing engineering and safety tests.
• Data Provenance: The testing was laboratory-based. No patient or clinical data provenance is mentioned as this is not a clinical performance study. The manufacturer is SonoScape Company Limited, located in Shenzhen, P.R. China.

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)

This information is not applicable. The submission is for a modified diagnostic ultrasound system, with the focus on safety and functional equivalence to a predicate device, rather than a new AI/CAD device requiring expert-established ground truth for a clinical test set.

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

This information is not applicable. There is no clinical test set requiring adjudication in this submission.

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

No MRMC study was done. This device is a diagnostic ultrasound system itself, not an AI/CAD system assisting human readers.

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

This is not applicable as the device is a diagnostic ultrasound system and not an AI algorithm.

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

This is not applicable in the context of clinical ground truth. For the engineering and safety testing, the "ground truth" would be the specified parameters and limits in the referenced standards (e.g., maximum acoustic output levels, electrical safety thresholds, biocompatibility criteria).

8. The sample size for the training set

This is not applicable. The device is a hardware ultrasound system, not an AI algorithm that requires a training set of data.

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

This is not applicable, as there is no training set for an AI algorithm.

Summary

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K112451

S8 Diagnostic Ultrasound System

Tab 19 PREMARKET NOTIFICATION 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:

Manufacturer:

SonoScape Company Limited

Address: 4/F., Yizhe Building, Yuquan Road,Nanshan, Shenzhen 518051,

P.R.China

Tel: [phone]

Fax: [phone]

Contact Person: Chen Zhiqiang

Date Prepared: July 12, 2011

Name of the device:

• • Trade/Proprietary Name:
• S8 Diagnostic Ultrasound System
• • Common Name: Diagnostic Ultrasound System and Transducers
• • Classification:

Regulatory Class: II

Review Category: Tier II

• 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-IYN)
• 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO)
• 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

Legally Marketed Predicate Device:

K092922, SonoScape S8 Diagnostic Ultrasound System

Premarket Notification 510(k) Summary

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Device Description:

The SonoScape S8 Ultrasound System, previously cleared under K092922, is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

The only modifications that were made are:

The original S8 Diagnostic Ultrasound System, was previously cleared in K092922 dated March 12, 2009, uses an internal SMPS as its power supply system. And the proposed device was redesigned, changing from AC to battery power, i.e. the internal Li-ion Battery Pack (with an external AC adapter). Such a change is accompanied by labeling changes, but not including new indication for use (See Tab 3).

Table 21.1 lists the differences between the two power supply systems.

ModelItem	S8K092922(with SMPS)	S8TBD(with Battery Pack and AC Adapter)
Powersupply	No battery pack is provided;The SMPS forms the powersupply system.	An internal battery pack is provided;The power supply system consists ofthe AC adapter and DC converterand a Li-ion Battery Pack.
WorkingPrinciple ofthe PowerSupply	The SMPS converts the 220Vor 110V mains voltage to theDC voltages (+12V, -12V, +5V,+3.3V, +5VSB) required by allthe electronic parts in the S8Series System.	The AC adapter converts the mainsvoltage (100-240V AC) to a DCvoltage of approximately +17.5V.Supplied with this DC voltage, theDC converter charges the batteryand also converts the DC voltage tothe lower voltages (+12V, -12V, +5V,+3.3V, +5VSB) required by all theelectronic parts in the S8 system,and at the same time controls theLED indicators on the controlpanel/keyboard.

Table 21.1 Comparison of the Switching Mode Power Supply (SMPS) System and the Battery Pack Power Supply System

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SonoScape Company LTD	S8 Diagnostic Ultrasound System
ModelItem	S8K092922(with SMPS)	S8TBD(with Battery Pack and AC Adapter)
ControlPanel/Keyboard	/	Compared to control panel of theoriginal certified product, three LEDshave been added at the bottom rightcorner of the control panel.
Remarks	1)Since the original S8 System does not have internal battery, itrequires the mains supply to operate. When no mains supply isprovided, the system can not be turned on.2)With the Li-ion Battery Pack, the S8 System can operate evenwhen no mains supply is available.

Intended Use:

The SonoScape S8 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, OB/Gyn and Urology. This is the same intended use as previously cleared for the SonoScape S8 Diagnostic Ultrasound System, K092922.

Probe Information:

No.	Probe	Type	Frequency Range	Intended Use
1	2P1	Phased Array	2.0-4.0 MHz	AbdominalNeonatal CephalicAdult CephalicCardiac AdultCardiac Pediatric
2	5P1	Phased Array	3.0-7.0 MHz	PediatricNeonatal CephalicCardiac Pediatric
3	6V1	Micro-curvedArray	4.0-8.0 MHz	Trans-rectalTrans-vaginal
4	6V3	Micro-curvedArray	5.0-9.0 MHz	Trans-rectalTrans-vaginal
5	EC9-5	Micro-curvedArray	5.0-9.0 MHz	Trans-rectalTrans-vaginal
6	C611	Micro-curvedArray	4.0-8.0 MHz	AbdominalPediatricNeonatal CephalicCardiac Pediatric

Tab 21.2 Probe information

Premarket Notification 510(k) Summary

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SonoScape Company LTD

S8 Diagnostic Ultrasound System

No.	Probe	Type	Frequency Range	Intended Use
7	C344	Curved Array	2.0-5.0 MHz	Fetal / Abdominal/ Ob/GYN
8	C362	Curved Array	2.0-6.0 MHz	Fetal / Abdominal/ Ob/GYN
9	VC6-2	Curved Array	2.0-6.0 MHz	Fetal / Abdominal/ Ob/GYN
10	L741	Linear Array	5.0-10.0 MHz	Small Organ (breast, thyroid, testes)Musculo-skeletal (Conventional)Peripheral vessel
11	L742	Linear Array	5.0-12.0 MHz	Small Organ (breast, thyroid, testes)Musculo-skeletal (Conventional)Musculo-skeletal (Superficial)Peripheral vessel
12	L743	Linear Array	5.0-10.0 MHz	Small Organ (breast, thyroid, testes)Musculo-skeletal (Conventional)Musculo-skeletal (Superficial)Peripheral vessel

Safety Considerations:

The S8 Diagnostic Ultrasound System incorporates the same fundamental technology as the predicate device. The device has been tested as Track 3 Device per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued September 9, 2008. The acoustic output is measured and calculated per NEMA UD 2: 2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment and NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5 and ISO 10993-10.

Testing:

Laboratory testing was conducted to verify that the S8 Diagnostic Ultrasound System met all design specification and was substantially equivalent to the currently marketed Predicate Device as above. The device has been found to

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SonoScape Company LTD

conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility. Acoustic output is measured and calculated according to "Acoustic Output Measuring Standard for Diagnostic Ultrasound Equipment".

Standards No.	Standards Title	Version	Date
IEC 60601-1	IEC 60601-1, Medical Electrical Equipment - Part 1:General Requirements for Safety, 1988;Amendment 1, 1991-11, Amendment 2, 1995.	1988	10/31/2005
IEC 60601-1-2	IEC 60601-1-2, (Second Edition, 2001), MedicalElectrical Equipment - Part 1-2: GeneralRequirements for Safety - Collateral Standard:Electromagnetic Compatibility - Requirements andTests.	2007	07/31/2008
IEC60601-2-37	IEC 60601-2-37 (2004) (2005) Amendment 2,Medical electrical equipment - Part 2-37: Particularrequirements for the basic safety and essentialperformance of ultrasonic medical diagnostic andmonitoring equipment.	2007	09/08/2009
NEMA UD 2	NEMA UD 2-2004, Acoustic Output MeasurementStandard for Diagnostic Ultrasound EquipmentVersion 3.	2004	09/08/2009
ISO 10993-5	ISO 10993-5:1999, Biological evaluation of medicaldevices -- Part 5: Tests for In Vitro cytotoxicity.	2009	09/12/2007
10993-10	ISO 10993-10:2002, Biological evaluation ofmedical devices - Part 10: Tests for irritation anddelayed-type hypersensitivity.	2002	09/12/2007

Tab 21.3 Applicable Safety Standards

Conclusion:

The conclusions drawn from testing of the S8 Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices.

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Image /page/5/Picture/1 description: The image shows a logo with a stylized bird-like symbol on the right and a circular arrangement of text on the left. The text appears to be "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES". The bird-like symbol is composed of curved lines, giving it a sense of motion or flight.

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

SonoScape Company Limited % Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 237-023 Shanghai, 200237 CHINA

SEP 16 2011

Re: K112451

Trade/Device Name: S8 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: 1YN, 1YO, and ITX Dated: August 24. 2011 Received: August 25. 2011

Dear Ms. Hong:

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 S8 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

2P1 Phase Arrav 5P1 Phase Array 6V ! Micro-curved Array 6V3 Micro-curved Array EC9-5 Micro-curved Arrav C611 Micro-curved Array C362 Curved Array C344 Curved Array

VC6-2 Curved Array L743 Linear Array L741 Linear Array L742 Linear Array

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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 vour 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/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 Shahram Vaezy, Ph.D. at [phone].

Sincerely Yours.

Mary S Postiff

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

Enclosure(s)

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Tab 3 Indications For Use

510(k) Number: Device Name: S8 Diagnostic Ultrasound System

• Indications for Use: The SonoScape S8 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, OB/Gyn and Urology.
  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)

May S. Patel

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K112451

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System: Sonoscape S8 Diagnostic Ultrasound Pulsed Echo System Diagnostic Ultrasound Pulsed Doppler Imaging System

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

Clinical Application		Mode of Operation
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal	P	P	P		P	P	Note 1	Notes 2,4,5
	Abdominal	P	P	P		P	P	Note 1	Notes 2,4,5
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	Notes 2,4
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2,4,6
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 24
	Adult Cephalic	P	P	P	P	P	P	Note 1	Notes 2, 4
	Trans-rectal	P	P	P		P	P	Note 1	Notes 2
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)	P	P	P		P	P	Note 1	Notes 2,4
	Musculo-skeletal(Superficial)	P	P	P		P	P	Note 1	Notes 2,4
	Intravascular
	Other (Ob/GYN)	P	P	P		P	P	Note 1	Notes 2,4,5
Cardiac	Cardiac Adult	P	P	P	P	P	P	Note 1	Notes 2,3
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2
	Other (specify)

N = new indication;

Prescription Use

P = previously cleared by FDA;

E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging.

(Part 21 CFR 801 Subpart D)

Note 5: 4D

Note 3: TDI Note 6: Small Organ: breast, thyroid, testes

X

Note 4: 3D

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)

510

Mary S. Patel

---

(Division Sign Off)

Indications For Use

Division Sign Division of Pradiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

K112451

3-2

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Transducer: 2P1 Phase Array

Diagnostic Ultrasound Transducer

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

Clinical Application			Mode of Operation
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&	Fetal
Other	Abdominal	P	P	P		P	P	Note 1	Notes 2
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2
	Adult Cephalic	P	P	P	P	P	P	Note 1	Notes 2
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult	P	P	P	P	P	P	Note 1	Notes 2,3
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel
Vessel	Other (specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M: B/PWD: B/THI; M/Color M : B/Color Doppler; B/Color Doppler;PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging.

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Note 5: 4D

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)

Man S. Patel

sion Sio Division of Radiological D Office of In

610K K112451

3-3

Indications For Use

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Transducer: 5P1 Phase Array Diagnostic Ultrasound Transducer

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

Clinical Application		Mode of Operation
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	Notes 2
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Other (specify)

P = previously cleared by E

appendix

Note 1: Other Combined includes: B/M; B/PWD; B/TH; M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging.

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

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

Note 5: 4D

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)

Indications For Use

Mary S. Patel
3-4

Division of Radiological Di Office of In Vitro Diagnostic De

510K

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Transducer: 6V1 Micro-curved Array Diagnostic Ultrasound Transducer

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

Clinical Application			Mode of Operation
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
Fetal	Fetal
Imaging&Other	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	Note 1	Notes 2
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Other (specify)
N = new indication;	Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/PowerDoppler/PWD			P = previously cleared by FDA;				E = added under this appendix
	Note 2: Tissue Harmonic Imaging.
Note 3: TDI	Note 4: 3D			Note 5: 4D
	Note 6: Small Organ: breast, thyroid, testes
Prescription Use	X			AND/OR				Over The Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Indications For Use

Maus. Potel 3-5
(Division Sign-Off)

Division of Radiologica Office of In and Sefety

510K K1124/S1

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Transducer: 6V3 Micro-curved Array Diagnostic Ultrasound Transducer

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

Clinical Application			Mode of Operation					Other*
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined	Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	Note 1	Notes 2
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)
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 this appendix

P = previously cleared by FDA;

E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging.

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Note 5: 4D

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)

Indications For Use

Mays Patel
(Division Sign-Off)

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

510K K12451

3-6

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

Transducer: EC9-5 Micro-curved Array Diagnostic Ultrasound Transducer

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

Clinical Application			Mode of Operation					Other*
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	Note 1	Notes 2
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Other (specify)
P = previously cleared by FDA;E = added under this appendixN = new indication;

P = previously cleared by FDA;

E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/TH; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 5: 4D

Note 2: Tissue Harmonic Imaging.

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

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)

・

Indications For Use

Mary S Patel 3-7
(Division Sign-Off)

Office of In and Safety

510K

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

Transducer: C611 Micro-curved Array Diagnostic Ultrasound Transducer

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

Clinical Application			Mode of Operation						Other*
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined	Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal
	Abdominal	P	P	P		P	P	Note 1	Notes 2
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	Notes 2
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Other (specify)

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler; WD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging.

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

Note 5: 4D

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)

Masa S. Patil 3-8
(Division Sign Off)

Division of Office of In and Safety

$$K_{112/1} \leq 1$$

510k

Indications For Use

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

Transducer: C362 Curved Array Diagnostic Ultrasound Transducer

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

Clinical Application			Mode of Operation					Other*
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined	Specify
Ophthalmic	Ophthalmic
FetalImaging &Other	Fetal	P	P	P		P	P	Note 1	Notes 2,4
	Abdominal	P	P	P		P	P	Note1	Notes 2,4
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)	P	P	P		P	P	Note 1	Notes 2,4
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 this annendix

Note 1: Other Combined includes: B/M; B/PWD; B/TH): M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging.

Note 4: 3D Note 3: TDI

Note 6: Small Organ: breast, thyroid, testes

Note 5: 4D

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. Patel
(Division Sign-Off)

Indications For Use

3-9 Division of Radiological De Office of In Vitro Diagnostic Device Evaluation and Safety

510K K1124S1

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

Transducer: C344 Curved Array Diagnostic Ultrasound Transducer

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

Clinical Application			Mode of Operation
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal	P	P	P		P	P	Note 1	Notes 2, 4
	Abdominal	P	P	P		P	P	Note 1	Notes 2, 4
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)	P	P	P		P	P	Note 1	Notes 2, 4
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 this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging.

Note 3: TDI Note 4: 3D

(Part 21 CFR 801 Subpart D)

Note 6: Small Organ: breast, thyroid, testes

X

AND/OR

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

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

Note 5: 4D

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

Indications For Use

Prescription Use

Mury Statt 3-10
(Division Sign-Off)

itro Diagnostic Device valuation and Safety

510F

{17}------------------------------------------------

Transducer: VC6-2 Curved Array

Diagnostic Ultrasound Transducer

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

Clinical Application		Mode of Operation
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic					P
FetalImaging &Other	Fetal	P	P	P		P	P	Note 1	Notes 2,4,5
	Abdominal	P	P	P		P	P	Note 1	Notes 2,4,5
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)	P	P	P		P	P	Note 1	Notes 2,4,5
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 this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging.

Note 3: TDI Note 4: 3D

(Part 21 CFR 801 Subpart D)

Note 6: Small Organ: breast, thyroid, testes

X

1

AND/OR

Note 5: 4D

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)

Indications For Use

Prescription Use

Marr S. Rotel 3-11
(Division Sign-Off)

and Safety

510k

{18}------------------------------------------------

Transducer: L743 Linear Array Diagnostic Ultrasound Transducer

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

Clinical Application			Mode of Operation
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
Fetal	Fetal
Imaging&
Other	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2, 4
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)	P	P	P		P	P	Note 1	Notes 2, 4
	Musculo-skeletal(Superficial)	P	P	P		P	P	Note 1	Notes 2, 4
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2, 4
Vessel	Other (specify)
P = previously cleared by FDA:E = added under this appendixN = new indication:

Note 1: Other Combined includes: BM; B/PWD; B/THI; M/Color Doppler; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging.

Note 4: 3D Note 3: TDI

Note 6: Small Organ: breast, thyroid, testes

Note 5: 4D

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 (OIVI)

es (OIVD)

(Division Sign Off)

Division of Badin Office of It

510K K11245-1

Indications For Use

{19}------------------------------------------------

Transducer: L741 Linear Array Diagnostic Ultrasound Transducer

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

Clinical Application			Mode of Operation
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2, 4
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)	P	P	P		P	P	Note 1	Notes 2, 4
	Musculo-skeletal(Superficial)	P	P	P		P	P	Note 1	Notes 2, 4
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2, 4
	Other (specify)
N = new indication;	P = previously cleared by FDA;							E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/TH); M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging.

Note 3: TDI Note 4: 3D

(Part 21 CFR 801 Subpart D)

Note 6: Small Organ: breast, thyroid, testes

X

AND/OR

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

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

Note 5: 4D

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

Indications For Use

Prescription Use

Macy S. Patel
(Division Sign-Off)

Office of aluation and Safety

510K KiizusT

3-13

{20}------------------------------------------------

Transducer: L742 Linear Array Diagnostic Ultrasound Transducer

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

Clinical Application	Mode of Operation
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2, 4
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)	P	P	P		P	P	Note 1	Notes 2, 4
	Musculo-skeletal(Superficial)	P	P	P		P	P	Note 1	Notes 2, 4
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2, 4
	Other (specify)

Note 1: Other Combined includes: BM; B/PW/J; M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging.

Note 3: TDI Note 4: 3D

(Part 21 CFR 801 Subpart D)

Note 6: Small Organ: breast, thyroid, testes

X

AND/OR

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

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

Note 5: 4D

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

Indications For Use

Prescription Use

Mary S. Pfohl
(Division Sign-Off)

Division of Radiological Devices Office of In valuation and Safety

510K KUZUSI

3-14

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.