K Number

Device Name

HERA I10 Diagnostic Ultrasound System

Manufacturer

Samsung Medison Co., Ltd.

Date Cleared

2019-05-22

(86 days)

Product Code

IYN ITX IYO

Regulation Number

892.1550

Intended Use

The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

Device Description

The HERA 110 is 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, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler. Pulse Inversion Harmonic Imaging (S-Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes. The HERA I10 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 HERA I10 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K182595

Reference Devices

K173513

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ultrasound imaging modes and analysis packages, not AI/ML-driven features.

Therapeutic

No.
The device's intended use is to "obtain ultrasound images and analyze body fluids" and to provide "information that is used to make a diagnosis." It is described as a "diagnostic ultrasound system," with no mention of therapeutic capabilities.

Diagnostic

Yes
The "Intended Use/Indications for Use" section explicitly states that the device is an "ultrasound diagnostic system," and the "Device Description" section further specifies it as a "diagnostic ultrasound system" that provides information used "to make a diagnosis."

SaMD (Software as a Medical Device)

The device description explicitly states it is a "diagnostic ultrasound system" and describes its function as acquiring ultrasound data and displaying it in various modes. This indicates the device includes hardware components (probes, system for data acquisition) in addition to software control.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis.
This device is an ultrasound system. Ultrasound is an in vivo (within the body) imaging modality that uses sound waves to create images of internal structures.
The intended use and device description clearly state that it obtains ultrasound images and analyzes body fluids through imaging. While it mentions analyzing body fluids, this is done through the visualization and measurement of these fluids within the body using ultrasound, not by testing samples outside the body.

Therefore, the HERA I10 is a diagnostic imaging device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The HERA I10 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

B-mode, M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler. Pulse Inversion Harmonic Imaging (S-Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes.

Anatomical Site

Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

Indicated Patient Age Range

Adult, Pediatric, Neonatal (for specific applications like small organ, neonatal cephalic). Specific probes also mention adult, pediatric, and neonatal patients for certain applications.

Intended User / Care Setting

Competent health care professionals.
Prescription Use (Part 21 CFR 801 Subpart D)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The subject of this premarket submission, HERA I10, did not require clinical studies to support substantial equivalence.

Non-Clinical Tests:
Acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety.
All migrated software functionality was evaluated using the same test criteria as the predicate for all applicable imaging modes to ensure that migration into a new system design did not compromise image quality with respect to the intended use of each feature.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K182595

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K173513

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol is a stylized depiction of a human figure. To the right of the symbol is a blue square containing the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

Samsung Medison Co., Ltd. % Ji Yea Lee Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA

May 22, 2019

Re: K190444

Trade/Device Name: HERA I10 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: February 21, 2018 Received: February 25, 2019

Dear Ji Yea Lee:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known)

K190444

Device Name HERA 110 Diagnostic Ultrasound System

Indications for Use (Describe)

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

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510(k) No.:

Device Name: HERA 110 Diagnostic Ultrasound System 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	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	N	N	N		N	Note 1	Notes 2, 3, 4, 7, 8, 9, 11, 14
	Abdominal (See Note 10)	N	N	N	N	N	Note 1	Notes 2, 4, 5, 6, 7, 8, 9, 11, 12, 14
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	N	N	N	N	N	Note 1	Notes 2, 7, 8, 9, 11
	Small Organ (See Note 5)	N	N	N	N	N	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 12, 14
	Neonatal Cephalic	N	N	N	N	N	Note 1	Notes 8, 9, 11
	Adult Cephalic	N	N	N	N	N	Note 1	Notes 7
	Trans-rectal	N	N	N		N	Note 1	Notes 2, 7, 8, 9, 11, 12
	Trans-vaginal	N	N	N		N	Note 1	Notes 2, 7, 8, 9, 11, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	N	N	N		N	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 12, 14
	Musculo-skel. (Superfic.)	N	N	N		N	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 12, 14
	Intra-luminal
	Other (See Note 13)	N	N	N		N	Note 1	Notes 2, 7, 8, 9, 12
	Cardiac Adult	N	N	N	N	N	Note 1	Notes 4, 7
Cardiac	Cardiac Pediatric	N	N	N	N	N	Note 1	Notes 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	N	N	N	N	N	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 14
	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: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C

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, 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: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

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510(k) No.:

Device Name: L3-12A for use with HERA I10

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	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 14
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	N	N	N		N	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 12, 14
	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, 8, 9, 11, 12, 14
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 12, 14
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 14
	Other (spec.)

N= new indication; P= previously cleared by FDA K182595; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+CW, B+CW, B+C+PW, B+PD+PW, B+PPH+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C

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: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 2: Includes imaging for guidance of biopsy

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510(k) No.:

Device Name: LA2-9A for use with HERA I10

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	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	N	N	N		N	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11,12
	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, 8, 9, 11,12
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11,12
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Other (spec.)

N= new indication: P= previously cleared by FDA K182595; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CW, B+C+PW, B+PD+PW, B+PPI+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C

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, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 9: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

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510(k) No.:

Device Name: LA4-18B for use with HERA I10

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	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
&
Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 12, 14
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P	P	P	Note 1	Note 2,5,6,7,8,9,11,12,14
	Musculo-skel. (Superfic.)	P	P	P	P	P	Note 1	Note 2,5,6,7,8,9,11,12,14
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 14
	Other (spec.)

N= new indication; P= previously cleared by FDA K182595; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+TD, B+C+PW, B+C+PW, B+DPD+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C

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, 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: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate Note 14: S-Fusion

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510(k) No.:

Device Name: CA1-7A for use with HERA I10

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	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Notes 2,4,7,8,9,11,14
	Abdominal (See Note 10)	P	P	P		P	Note 1	Notes 2,6,7,8,9,11,14
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 2,6,7,8,9,11,14
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Notes 2,6,7,8,9,11,14
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	P	P	P		P	Note 1	Notes 2,6,7,8,9,11,14
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note 1	Notes 2,6,7,8,9,11,14
	Other (spec.)

N= new indication; P= previously cleared by FDA K182595; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+TD, B+C+PW, B+C+PW, B+DPD+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C

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, 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: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate Note 14: S-Fusion
- Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

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510(k) No.:

Device Name: CA2-9A for use with HERA I10

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	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Notes 2,4,7,8,9,11,14
	Abdominal (See Note 10)	P	P	P		P	Note 1	Notes 2,6,7,8,9,11,14
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	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 (See Note 13)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K182595; E= added under Appendix E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+TD, B+C+PW, B+C+PW, B+DPD+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C

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, 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: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion

Image /page/9/Picture/0 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The font is sans-serif and appears to be bolded.

510(k) No.:

Device Name: CA3-10A for use with HERA I10

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	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P	P	P	Note 1	Notes 2, 3, 7, 8, 9, 11,14
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 11, 14
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 11, 14
	Small Organ (See Note 5)
	Neonatal Cephalic	N	N	N	N	N	Note 1	Notes 2, 7, 8, 9, 11, 14
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 11, 14
	Musculo-skel. (Superfic.)	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 11, 14
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 11, 14
	Other (spec.)

N= new indication; P= previously cleared by FDA K182595; E= added under Appendix E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+TD, B+CW, B+C+PW, B+C+PW, B+PD+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C

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, 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: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion

Image /page/10/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The oval is tilted slightly, giving the logo a dynamic appearance.

510(k) No.:

Device Name: CF4-9 for use with HERA I10

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	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Notes 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Notes 7, 8, 9, 11
	Small Organ (See Note 5)
	Neonatal Cephalic	P	P	P	P	P	Note 1	Notes 7, 8, 9, 11
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	Note 1	Notes 8, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K182595; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C

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, 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: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Image /page/11/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold, sans-serif font, set against a blue oval background. The oval is tilted slightly, giving the logo a dynamic appearance.

510(k) No.:

Device Name: E3-12A for use with HERA I10

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	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 12
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
&
Other	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 12, 14
	Trans-vaginal	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 12, 14
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K182595; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPL, B+CW, B+CW, B+C+PW, B+PD+PW, B+PPH+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C

Note 3: Includes infertility 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: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 2: Includes imaging for guidance of biopsy

Image /page/12/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue, oval-shaped background. The font is sans-serif and bold, and the logo is clean and modern.

510(k) No.:

Device Name: EA2-11B for use with HERA I10

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	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)		P	P	P	P	P	Note 1	Notes 2, 7, 8, 9
	Abdominal (See Note 10)		P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 12
	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	P	Note 1	Notes 2, 7, 8, 9, 12, 14
	Trans-vaginal		P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)		P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 12, 14
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K182595; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPL, B+CW, B+CW, B+C+PW, B+PD+PW, B+PPH+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C

Note 3: Includes infertility 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: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 2: Includes imaging for guidance of biopsy

Image /page/13/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The oval is tilted slightly, giving the logo a dynamic appearance.

510(k) No.:

Device Name: VR5-9 for use with HERA I10

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	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 12
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
&
Other	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 12
	Trans-vaginal	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 12,
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K173513; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPL, B+CW, B+CW, B+C+PW, B+PD+PW, B+PPH+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C

Note 3: Includes infertility 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: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 2: Includes imaging for guidance of biopsy

Image /page/14/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue, oval-shaped background. The font is sans-serif and bold, and the logo is clean and modern.

510(k) No.:

Device Name: PA4-12B for use with HERA I10

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	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Note 7
	Small Organ (See Note 5)
	Neonatal Cephalic	P	P	P	P	P	Note 1	Note 7
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult	P	P	P	P	P	Note 1	Note 4, 7
	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K182595; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C

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, 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: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Image /page/15/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue, oval-shaped background. The font is sans-serif and bold, and the logo is clean and modern.

510(k) No.:

Device Name: PA3-8B for use with HERA I10

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	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Note 7
	Small Organ (See Note 5)
	Neonatal Cephalic	P	P	P	P	P	Note 1	Note 7
	Adult Cephalic	P	P	P	P	P	Note 1	Note 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult	P	P	P	P	P	Note 1	Note 4, 7
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K182595; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C

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, 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: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Image /page/16/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The oval is tilted slightly, giving the logo a dynamic appearance.

510(k) No.:

Device Name: PM1-6A for use with HERA I10

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	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
&
Other	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	Note 1	Note 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult	P	P	P	P	P	Note 1	Note 4, 7
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K182595; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C

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, 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: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Image /page/17/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The oval is tilted slightly, giving the logo a dynamic appearance.

510(k) No.:

Device Name: CV1-8A for use with HERA I10

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	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Note 2, 4, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P		P	Note 1	Note 2, 4, 7, 8, 9
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	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 (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)

Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K182595; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C

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, 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: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Image /page/18/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The oval is tilted slightly, giving the logo a dynamic appearance.

510(k) No.:

Device Name: EV3-10B for use with HERA I10

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	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 11, 12
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 11, 12
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
&
Other	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 11, 12
	Trans-vaginal	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 11, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 11, 12
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K182595; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C

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, 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: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

6. 510(K) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date Prepared February 21, 2019 1.
1. Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, REPUBLIC OF KOREA
1. Primary Contact Person Ji Yea Lee Regulatory Affairs Specialist Phone: +82.2.2194.1594 Fax: +82. 31.8017.9573 Email: jiyea722.lee@samsungmedison.com Contact Person Scully Kim Regulatory Affairs Specialist Phone: +82.2.2194.1312 Fax: +82. 31.8017.9573 Email: scully.kim@samsungmedison.com
1. Proposed Device (K190444)
- Common/Usual Name: Diagnostic Ultrasound System and Accessories
- Proprietary Name: HERA 110 Diagnostic Ultrasound System
- Common Name: Diagnostic Ultrasound System
- Classification Names: system, imaging, pulsed doppler, ultrasonic -
- Product Code: IYN, IYO, ITX ı
- Regulation: 892.1550, 892.1560, 892.1570 ၊
ડ. Predicate Device
HERA W10 Diagnostic Ultrasound System (K182595) ।
1. Device Description

1. Intended Uses
  The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional,

K190444

Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

1. Technology The HERA I10 employs the same fundamental scientific technology as its predicate device.

Determination of Substantial Equivalence 9.

The proposed HERA I10 is substantially equivalent to the predicate devices with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness.

| Feature | HERA I10
(Under Review) | HERA W10
(K182595) |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Samsung Medison, Co.,LTD | Samsung Medison, Co.,LTD |
| Intended Use | The HERA I10 Diagnostic Ultrasound
System and transducers are intended
for diagnostic ultrasound imaging and
fluid analysis of the human body. | The HERA W10 Diagnostic
Ultrasound System and transducers are
intended for diagnostic ultrasound
imaging and fluid analysis of the
human body. |
| Clinical
Application | - Fetal/Obstetrics

Abdominal
Gynecology
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Muscular-Skeletal (Conventional,
Superficial)
Urology
Cardiac Adult
Cardiac Pediatric
Peripheral vessel | - Fetal/Obstetrics
Abdominal
Gynecology
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Muscular-Skeletal (Conventional,
Superficial)
Urology
Cardiac Adult
Cardiac Pediatric
Peripheral vessel |
| Scanhead Types | - Linear Array
Curved Linear Array
Endocavity
Phased Array | - Linear Array
Curved Linear Array
Endocavity
Phased Array |
| Scanhead
Frequency | 1.0 ~ 20.0 MHz | 1.0 ~ 20.0 MHz |
| Acoustic Output
Display & FDA
Limits | - Display Feature for Higher Output—
Track3
MI Output Display
TI Output Display | - Display Feature for Higher Output—
Track3
MI Output Display
TI Output Display |
| Modes of
Operation | - B-mode
M-mode
Pulsed wave (PW) Doppler
Continuous wave (CW) Doppler
Color Doppler
Tissue Doppler Imaging (TDI) | - B-mode
M-mode
Pulsed wave (PW) Doppler
Continuous wave (CW) Doppler
Color Doppler
Tissue Doppler Imaging (TDI) |
| Feature | HERA I10
(Under Review) | HERA W10
(K182595) |
| | - Tissue Doppler Wave (TDW) | - Tissue Doppler Wave (TDW) |
| | - Power Amplitude Doppler | - Power Amplitude Doppler |
| | - Pulse Inversion Harmonic Imaging
(S-Harmonic) | - Pulse Inversion Harmonic Imaging
(S-Harmonic) |
| | - Directional Power Doppler (S-Flow) | - Directional Power Doppler (S-Flow) |
| | - Color M-Mode | - Color M-Mode |
| | - 3D Imaging Mode | - 3D Imaging Mode |
| | - 4D Imaging Mode | - 4D Imaging Mode |
| | - Elastoscan+TM Mode | - Elastoscan+TM Mode |
| | - MV-Flow Mode | - MV-Flow Mode |
| | - Tissue Harmonic Imaging | - Tissue Harmonic Imaging |
| | - Combination Modes | - Combination Modes |
| #Transmit
Channels | 192 | 192 |
| #Receive
Channels | 192 | 192 |
| System
Characteristics: | - Beamformer 192
Mobile cart
LCD Monitor (LED Backlight unit)
256 gray shades on monitor
100-240VAC, 1100VA, 50/60Hz | - Beamformer 192
Mobile cart
LCD Monitor (LED Backlight unit)
256 gray shades on monitor
100-240VAC, 1100VA, 50/60Hz |
| Product Safety
Certification | - IEC 60601-1
IEC 60601-1-2-37
CSA C22.2 No.601.1 | - IEC 60601-1
IEC 60601-1-2-37
CSA C22.2 No.601.1 |
| EMC Compliance | IEC 60601-1-2 | IEC 60601-1-2 |
| Acoustic Output
Display Standard | Track 3 | Track 3 |
| Biocompatibility
Compliance | ISO10993-1 | ISO10993-1 |
| Functionality | - Q Scan
ClearVision
MultiVision
Panoramic
Needle Mate
Auto IMT+
Strain+
Elastoscan
E-Thyroid
E-Breast
E-Strain
S-Detect for Breast
S-Detect for Thyroid
ADVR
3D Imaging
(Volume Data Acquisition) | - Q Scan
ClearVision
MultiVision
Panoramic
Needle Mate
Auto IMT+
Strain+
Elastoscan
E-Thyroid
E-Breast
E-Strain
S-Detect for Breast
S-Detect for Thyroid
ADVR
3D Imaging
(Volume Data Acquisition) |
| Feature | HERA I10
(Under Review) | HERA W10
(K182595) |
| | - 3D Imaging presentation | - 3D Imaging presentation |
| | - 3D Cine/4D Cine | - 3D Cine/4D Cine |
| | - 3D Rendering MPR | - 3D Rendering MPR |
| | - 3D XI MSV/Oblique View | - 3D XI MSV/Oblique View |
| | - Volume CT | - Volume CT |
| | - 3D MagiCut | - 3D MagiCut |
| | - Volume Calculation | - Volume Calculation |
| | - (VOCAL, XI VOCAL) | - (VOCAL, XI VOCAL) |
| | - XI STIC | - XI STIC |
| | - HDVI | - HDVI |
| | - Realistic Vue | - Realistic Vue |
| | - CEUS+ | - CEUS+ |
| | - HQ Vision | - HQ Vision |
| | - MV-Flow | - MV-Flow |
| | - Crystal Vue | - Crystal Vue |
| | - CrystalVue Flow | - CrystalVue Flow |
| | - 5D CNS+ | - 5D CNS+ |
| | - 5D Follicle | - 5D Follicle |
| Transducers | - 5D Heart Color | - 5D Heart Color |
| | - 5D Limb Vol | - 5D Limb Vol |
| | - 5D LB | - 5D LB |
| | - 5D NT | - 5D NT |
| | - 2D NT | - 2D NT |
| | - IOTA-ADNEX | - IOTA-ADNEX |
| | - Biometry Assit | - Biometry Assit |
| | - E-Cervix | - E-Cervix |
| | - Lumi-Flow | - Lumi-Flow |
| | - ShadowHDR | - ShadowHDR |
| | - MPI+ | - MPI+ |
| | - L3-12A | - L3-12A |
| | - LA2-9A | - LA2-9A |
| | - LA4-18B | - LA4-18B |
| | - CA1-7A | - CA1-7A |
| | - CA2-9A | - CA2-9A |
| | - CA3-10A | - CA3-10A |
| | - CF4-9 | - CF4-9 |
| | - E3-12A | - E3-12A |
| | - EA2-11B | - EA2-11B |
| | - VR5-9 | - VR5-9 |
| | - PA4-12B | - PA4-12B |
| | - PA3-8B | - PA3-8B |
| | - PM1-6A | - PM1-6A |
| | - CV1-8A | - CV1-8A |
| | - EV3-10B | - EV3-10B |
| Biopsy Guides | - BP-KIT-029 | - BP-KIT-029 |
| | - BP-KIT-041 | - BP-KIT-041 |
| | - BP-KIT-043 | - BP-KIT-043 |
| Feature | HERA I10
(Under Review) | HERA W10
(K182595) |
| | - BP-KIT-054 | - BP-KIT-054 |
| | - BP-KIT-057 | - BP-KIT-057 |
| | - BP-KIT-058 | - BP-KIT-058 |
| | - BP-KIT-059 | - BP-KIT-059 |
| | - BP-KIT-060 | - BP-KIT-060 |
| | - BP-KIT-065 | - BP-KIT-065 |
| | - BP-KIT-066 | - BP-KIT-066 |
| | - BP-KIT-067 | - BP-KIT-067 |
| | - BP-KIT-069 | - BP-KIT-069 |
| | - BP-KIT-071 | - BP-KIT-071 |
| | - BP-KIT-076 | - BP-KIT-076 |
| | - BP-KIT-077 | - BP-KIT-077 |
| | - BP-KIT-078 | - BP-KIT-078 |
| Digital
Storage/Transfer
Station | - Digital Storage/Transfer Station
Foot Switch
ECG
Gel Warmer
WLAN Adapter | - Digital Storage/Transfer Station
Foot Switch
ECG
Gel Warmer
WLAN Adapter |

10. Summary of Non-Clinical Test

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The HERA 110 and its applications comply with voluntary standards.

Test	Standards and FDA Guidance
Risk Management	ISO 14971 Second edition 2007 Medical devices - Application of risk
management to medical devices
Electrical Safety	The HERA I10 Ultrasound System with defibrillation-proof ECG
electrode was evaluated per the following standards.
IEC 60601-1:2005+AMD1:2012
Medical Electrical Equipment - Part 1: General Requirements for basic
safety and essential performance.
Electromagnetic Compatibility	IEC60601-1-2: 2014(4th Edition) Medical Electrical Equipment -- Part 1-
2: General Requirements For Basic Safety And Essential Performance --
Collateral Standard: Electromagnetic Disturbances -- Requirements And
Tests
Biocompatibility	ISO 10993-1 Fourth edition 2009-10-15 Biological evaluation of medical
devices - Part 1: Evaluation and testing within a risk management process.
Reprocessing Medical Devices	FDA Guidance: Reprocessing Medical Devices in Health Care Settings:
Validation Methods and Labeling issued on March 17, 2015, revised June
9, 2017.
Software/Firmware-driven
Functionality	All migrated software functionality was evaluated using the same test
criteria as the predicate for all applicable imaging modes to ensure that
migration into a new system design did not compromise image quality
with respect to the intended use of each feature.

| | Guidance for the Content of Premarket Submissions for Software
Contained in Medical Devices issued on May 11, 2005 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Information for Manufacturers Seeking Marketing Clearance of
Diagnostic Ultrasound Systems and Transducers issued September 9, 2008 |
| Ultrasound Safety | IEC60601-2-37:2007 + A1:2015, Particular requirements for the safety of
ultrasonic medical diagnostic and monitoring equipment |
| | NEMA UD 2-2004 (R2009)
Acoustic Output Measurement Standard for Diagnostic Ultrasound
Equipment Revision 3 |
| | NEMA UD 3-2004 (R2009)
Standard for Real-Time Display of Thermal and Mechanical Acoustic
Output Indices on Diagnostic Ultrasound Equipment, Revision 2 |

11. Summary of Clinical Tests

The subject of this premarket submission, HERA I10, did not require clinical studies to support substantial equivalence.

12. Conclusion

SAMSUNG MEDISON CO., LTD. considers the HERA I10 to be as safe, as effective, and performance is substantially equivalent to the predicate device.

END of 510(K) Summary