The SONOACE R7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.

Device Description

The SONOACE R7 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color Doppler imaging, Power Doppler imaging, PW/CW Spectral Doppler mode, Harmonic imaging, 3D imaging mode or as a combination of these modes. The SONOACE R7 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The SONOACE R7 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

AI/ML Overview

The provided text is a 510(k) Summary for the SAMSUNG MEDISON CO., LTD. SONOACE R7 Diagnostic Ultrasound System and its various transducers. This type of document is a premarket notification to the FDA, demonstrating substantial equivalence to a legally marketed predicate device. It does not contain information about a study that proves the device meets specific acceptance criteria in the way a clinical trial would for an AI/CADe device.

Instead, the document focuses on demonstrating that the SONOACE R7 (and its transducers) has technological characteristics and intended uses substantially equivalent to previously cleared predicate devices (K102065, SONOACE R7 Diagnostic Ultrasound System; K093714, SONOACE X8 Diagnostic Ultrasound System; and K103722 for specific transducers).

Therefore, I cannot populate the table or answer most of the questions as they pertain to a clinical study demonstrating performance against acceptance criteria for a new clinical indication or an AI/CADe device. The regulatory pathway for this device is based on substantial equivalence, not on proving specific diagnostic performance metrics through clinical trials.

Here's what can be extracted based on the provided text, and where information is not available:

1. Table of acceptance criteria and the reported device performance

This information is not available in the provided document. The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing or reporting specific performance metrics against pre-defined acceptance criteria for diagnostic accuracy, sensitivity, specificity, etc. for a new clinical claim. The "acceptance criteria" here implicitly refer to meeting safety and performance standards equivalent to the 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)

This information is not available. The submission is a 510(k) for an ultrasound system, not a study reporting diagnostic performance metrics. It does not mention any "test set" in the context of diagnostic accuracy evaluation.

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 available. There is no mention of a test set with ground truth established by experts.

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

This information is not available. There is no mention of an adjudication method for a test set.

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

This information is not available. The device described is a diagnostic ultrasound system (hardware and associated software for image acquisition and display), not an AI/CADe (Computer-Aided Diagnosis/Detection) device that would involve AI assistance for human readers or require MRMC studies in this context.

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

This information is not available. This is not an AI/CADe device, and therefore "standalone" algorithm performance is not applicable in this context. The device is a tool used by a human operator for diagnostic imaging.

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

This information is not available. No diagnostic performance study using a ground truth is described.

8. The sample size for the training set

This information is not available. There is no mention of a "training set" as this is not an AI/CADe device.

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

This information is not available. There is no mention of a "training set" or its ground truth establishment.

Summary

{0}------------------------------------------------

Special 510(k)

OCT 1 2 2011

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR. Part 807, Subpart E. Section 807.92.

1. Submitter's Information: 21 CFR 807,92(a)(1)

SAMSUNG MEDISON CO., LTD. 1003, Daechi-dong, Gangnam-gu, Seoul 135-280, Korea

Contact Person:

Kyeong-Mi, Park Regulatory Affairs Manager

Telephone:	82.2.2194.1381
Facsimile:	82.2.556.9209

Data Prepared: July 11, 2011

2. Name of the device:

Common/Usual Name: Diagnostic Ultrasound System and Accessories Proprietary Name: SONOACE R7 Diagnostic Ultrasound System Classification Names: FR Number Product Code Ultrasonic Pulsed Doppler Imaging System 892.1550 IYN Ultrasound Pulsed Echo Imaging System 892.1560 IYO Diagnostic Ultrasound Transducer 892.1570 ITX

3. Identification of the predicate or legally marketed device:

K 102065, SONOACE R7 Diagnostic Ultrasound System K093714, SONOACE X8 Diagnostic Ultrasound System

{1}------------------------------------------------

4. Device Description:

The SONOACE R7 has been designed to meet the following product safety standards:

UL 60601-1, Safety requirements for Medical Equipment
CSA C22.2 No. 601.1, Safety requirements for Medical Equipment
IEC60601-2-37, Diagnostic Ultrasound Safety Standards
EN/IEC60601-1, Safety requirements for Medical Equipment
EN/IEC60601-1-2, EMC requirements for Medical Equipment
NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
IEC 61157, Declaration of the acoustic output
ISO10993-1, Biocompatibility

5. Intended Uses:

The SONOACE R7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.

6. Technological Characteristics:

The SONOACE R7 is substantially equivalent to the SONOACE R7 Diagnostic Ultrasound System, cleared via K102065, and the SONOACE X8 Diagnostic Ultrasound System, cleared via K093714. All systems transmit ultrasonic energy into patients, then perform post processing of received choes to generate on-screen display of anatomic structures and fluid flow within the body. All system allow for specialized measurements of structures and flow, and calculations.

END of 510(K) Summary

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Image /page/2/Picture/1 description: The image shows a logo with a circular border containing text, surrounding a stylized bird-like symbol. The text within the circular border appears to be in all caps, but is difficult to read due to the image quality. The bird-like symbol is composed of three curved lines, resembling the silhouette of a bird in flight.

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

Samsung Medison Co., Lid. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LL.C. 1394 25th Street NW BUFFALO MN 55313

OCT 1 2 2011

Re: K112646

Trade/Device Name: SONOACE R7 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: TYN, IYO, and ITX Dated: September 9, 2011 Received: September 12, 2011

Dear Mr. Job:

We have reviewed vour 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 SONOACE R7 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

( C2-5	FILD2 Cﻤﺎ ﻳﻮﻧﻴﻮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ	-4-9/10ET
10EL, 4-1ﺗﺘﻠ	P2-4AH	1-ND-/
-013114-11------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	3DC2-6	S - .ેતા
ን - አ------------	3D4-8ET	3104-0HS
2/50EPt-1 -i	( ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------l---------

{3}------------------------------------------------

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 vour 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 (QS) 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/ReportalProblem/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 Jay Vaishnav at (301) 796-9580.

Sincerely Yours.

Michael O'Hearn for

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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SECTION 1.3 INDICATIONS FOR USE

510(k) Number (if known): _Kl12646

Device Name: SONOACE R7 Diagnostic Ultrasound System

Indications for Use:

The SONOACE R7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound innaging and fluid analysis of the human body.

The clinical applications include: Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial). Cardiac Pediacric, Peripheral vessel.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

(Division Sign-Off)

Division of Radiological Devic Office of In Vitro Diagnostic Device Evaluation

510K K112646

Indications for Use

{5}------------------------------------------------

510(k) No.:

Device Name: SONOACE R7 Diagnostic Ultrasound System

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

Climical Application			Mode of Operation ( *includes simultancous B-mode)
General	Specific	ి.	M	PWD	CIVD	Color	Combined *	Other
(Track I only)	(Tracks 1 & III)					Doppler*	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	រ្យ	P	>		P	Note I	Notes 2, 7, 8
	Abdominal	い	P	p	l>	p	Note I	Notes 2, 4, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
ಳOther	Pediatric	। >	P	P		ြာ	Note I	Note 2. 5. 6. 7. 8. 9
	Small Organ (See Note 5)	P	1 >	>		{}	Note 1	Note 2, 5, 6, 7, 9
	Neonatal Cephalic	א	71	7		ਮ	Note	Notes 2. 8
	Adult Cephalic	P	P	י	P	ן י	Note I	Note 4, 7
	Trans-rectal	p	ប្រ	11		יי	Note l	Note 2. S
	Trans-vaginal	p	ﻟﺴﺎ	( )		P	Note 1	Note 2. 8
	Trans-urethral
	Trans-esoph. (non-Cardiae)
	Musculo-skel. (Convent.)	יי	್ಕೆ )	( )		P	Note I	Note 2, 5, 6, 7, 9
	Musculo-skel. (Supertic.)	P	ని	ું »		p	Note I	Note 2. 5. 6. 7. 9
	Intra-luminal
	Other (spec.)
	Cardiac Adult	P	ប្រ	్రా	ర్	P	Note I	Note 4, 7
Cardiac	Cardiae Pediatric	】	្រ	12	్రా	P	Note I	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	ប្រ	్‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌	ీ		P	Note I	Note 2, 5. 6, 7, 9
Vessel	Other (spec.)

N= new indication: P= previously cleared by FDA K102065; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: BIM, B/PWD, B/Color Doppler/PWD, B/Power Doppler/PWD, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Devic

510K K112646

{6}------------------------------------------------

510(k) No.:

Device Name: C2-8 for use with SONOACE R7

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track 1 only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal ( See Note 3 )	P	P	P		P	Note 1	Notes 2, 7, 8
	Abdominal	P	P	P		P	Note 1	Notes 2, 7, 8
	Intra-operative ( See Note 6 )
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 2, 7, 8
	Small Organ ( See Note 5 )
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)

PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K102065; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: BAM, B/PWD, B/Color Dopplex, B/Color Dopplex/PWD, B/Power Dopplex/PWD, (8/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsv

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, serotum and penis in adult, pediatrie and neonatal patients

5104

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 3: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)

Division Sign-Off

Division of Radiological Devices Office of In Vitro Diagnos aluation and Safety

{7}------------------------------------------------

510(k) No .:

Device Name: ER4-9/10ED for use with SONOACE R7

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

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Notes 2, 8
	Trans-vaginal	P	P	P		P	Note 1	Notes 2, 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminat
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously eleared by FDA K102065; E= added under Appendix E

.510K

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M. B/PWD, B/Color Dopplex, B/Color Dopple:/PWD, B/Power Dopplex/PWD, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertifity monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

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

{8}------------------------------------------------

Special 510ck)

DIACNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: EV4-9/10ED for use with SONOACE R7 Intended Use: Diagnostic ultrasound imaging or thuid flow analysis of the human body as follows:

	Mode of Operation (*includes simultaneous B-mode)Clinical Application
General	Specific	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
(Track I only)	(Tracks 1 & 111)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note I	Notes 2, 8
	Trans-vaginal	P	P	P		P	Note I	Notes 2, 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Supertic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K102065; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/L/WD, B/Color Doppler, B/Calor Dapplex/PWD, B/Power Dopplex/Color Dopplex/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, seroum and penis in adult, pediatic and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7; Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OLVD) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

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

510K K112646

{9}------------------------------------------------

510(k) No.:

Device Name: L3-S for use with SONOACE R7 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Musculo-skel. (Superfic.)	P	P	P		P	Note !	Note 2, 5, 6, 7, 9
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note I	Note 2, 5, 6, 7, 9
	Other (spec.)

N= new indication; P= previously cleared by FDA KH02065; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: BAM, B/PWD, B/Color Dopplex/B/Color Dopplex/PWD, B/Power Dopplex/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, serotum and penis in adult, pediativ and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 3: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

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

Indications for Use

510K K112646

{10}------------------------------------------------

510(k) No .:

Device Name: L5-12/50EP for use with SONOACE R7

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

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & II)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Other (spec.)

N= new indication; P= previously cleared by FDA K102065; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/Color Dopplex/PWD, B/Power Dopplex/PWD, B/Color Dopplex/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neconatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9. Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 301.109)

Avinash Patel
(Division Sign-Off)

Division of Radiological Det Office of In Vitro Diagno and Safety

Indications for Use

510K K1126416

{11}------------------------------------------------

510(k) No.:

Device Name: HL.5-12ED for use with SONOACE R7 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks 1 & III)	B	M	PWD	CWD	ColorDoppler*	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note I	Note 2, 5, 6, 7, 9
	Small Organ (See Note 3)	P	P	P		P	Note I	Note 2, 5, 6, 7, 9
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note I	Note 2, 5, 6, 7, 9
	Musculo-skel. (Superfic.)	P	P	P		P	Note I	Note 2, 5, 6, 7, 9
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note I	Note 2, 5, 6, 7, 9
	Other (spec.)

N= new indication: P= previously cleared by FDA K102065; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/Color Doppler/PWD, B/Power Dopplex/PWD, B/Color Dopplex/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

· Note 4: Color M-mode

Note 5: For example: thyroid, breast, scrown and penis in adult, pediatio and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Hannonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)

Richard D. Tilman

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

510K K1126416

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

510(k) No .:

Device Name: P2-4AH for use with SONOACE R7

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal	P	P	P	P	P	Note I	Note 4, 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	Note I	Note 4, 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Supertic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult	P	P	P	P	P	Note I	Note 4, 7
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note I	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K102065; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/N, B/PWD, B/Color Doppler. B/Color Dopplex/PWD, B/Power Dopplex/PWD, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsv

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, serotum and penis in adult, pediatic and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 3: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Radiolonical Devices Office of In Vitro Diacnostic D Evaluation and Safety

Indications for Use .

510H

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

510(k) No .: Device Name: 3DC2-6 for use with SONOACE R7 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & II)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	P	P	P		P	Note 1	Note 2, 7, 8
	Abdominal	P	P	P		P	Note 1	Note 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Note 2, 7, 3
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Supertic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K102065; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/Color Dopplex, B/Color Dopplex/PWD, B/Power Dopplex/PWD, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, serotum and penis in adult, pediatic and neonatal patients

SIOK

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 3: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801,109)

Alisa Roth

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

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

510(k) No.: Device Name: 3D4-8ET for use with SONOACE R7

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	P	P	P		P	Note I	Note 2, 7, 8
	Abdominal	P	P	P		P	Note I	Note 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note I	Note 2, 7, 8
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication: ?= previously cleared by FDA K102065; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note I : B/M, B/PWD, B/Color Doppler/PWD, B/Power Dopplex/PWD, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes intertility monitoring of follicle development

Note 4: Color M-mode

Note >: For example: thyroid, breast, scrown and penis in adult, pediatic and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D minging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

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

Indications for Use .

510K K112646

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

510(k) No :

Device Name: C2-5 for use with SONOACE R7

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & II!)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal ( See Note 3 )	N	N	N	N	N	Note 1	Notes 2, 7, 8
	Abdominal	N	N	N	N	N	Note 1	Notes 2, 7, 8
	Intra-operative ( See Note 6 )
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	N	N	N	N	N	Note 1	Notes 2, 7, 8
	Small Organ ( See Note 5 )
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac	Cardiac Adult
		Cardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: BiM. B/PWD, B/Color Doppler, B/Color Dopplex/PWD, B/Power Dopplex/PWD, B/Color Dopplex/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, scrown and penis in adult, pediatric and neonatal patients

510K

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription Use (Per 21 CFR 801.109)

Mark D. Ott

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

Indications for Use

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

510(k) No .:

Device Name: C4-9/10ED for use with SONOACE R7

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

Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal (See Note 3)	P	P	P		P	Note I	Notes 2, 8
	Abdominal	P	P	P		P	Note I	Notes 2, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	Note I	Notes 2, S
	Small Organ (See Note 3)	P	P	P		P	Note I	Notes 2. S
	Neonatal Cephalic	P	P	P		P	Note I	Notes 2. 3
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note I	Notes 2, 8
	Other (spec.)

N= new indication: P= previously cleared by FDA K093714: E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD. B/Color Dopplex, B/Color Dopplex/PWD, B/Power Dopplex/PWD, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, serotum and penis in adult, pediarie and neonatal patients

510K

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Hannonic Imaging (THI)

Note 8. 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Preseription Use (Per 21 CFR 801 109)

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

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

510(k) No.:

Device Name: LN5-12 for use with SONOACE R7

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track 1 only)	Specific(Tracks 1 & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 2,5,6
	Small Organ (See Note 5)	P	P	P		P	Note 1	Notes 2.5.6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Notes 2,5,6
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Notes 2.5.6
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1	Notes 5,6
	Other (spec.)

N= new indication; P= previously cleared by FDA K103722; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/Color Dopplex PWD, B/Power DapplexPWD, BrColor DopplexColor M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertifity monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, serotum and penis in adult, pediativ and neveaux patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note S: JD imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription Use (Per 21 CFR 801.109)

Michael D. O'Brien
(Division Sign-Off)

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

510K K112646

Section 1.3, page 14

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

510(k) No.: Device Name: P3-7AC for use with SONOACE R7 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks 1 & III)	B	M	PWD	CWD	ColorDoppler *	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 5)
	Abdominal	P	P	P	P	P	Note I	Note 4, 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	Note I	Note 4, 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Supertic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult	P	P	P	P	P	Note I	Note 4, 7
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note I	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K093714; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/Color Dopplex, B/Color Dapplex/PWD, B/Power Doppler/PWD, B/Color Doppler/Color M

Note 2: Includes innaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, serotum and penis in adult, pediatie and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonie Imaging (THI)

Note $. 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

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

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

510(k) No .:

Device Name: 3D4-9ES for use with SONOACE R7

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks 1 & III)	B	M	PWD	CWD	Color Doppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Note 2, 7, 3
	Trans-vaginal	P	P	P		P	Note 1	Note 2, 7, 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication: P= previously cleared by FDA K093714; E= added under Appendix E

510K

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/Color Doppler/PWD, B/Power Dopplex/PWD, B/Color Dopplex/Color M

Note 2; Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, serotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (TI-II)

Note 8- 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OFVD)
Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

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

Indications for Use

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.