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K Number
K103152
Device Name
6250 ULTRASOUND SYTEMS
Manufacturer
ESAOTE, S.P.A.
Date Cleared
2011-01-07

(73 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Esaote's Model 6250 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac. Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic. Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6250 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasound session. The second modality provides additional security in assessing the morphology of the ultrasound image. Virtual Navigator can be used in the following application: Abdominal, Musculo-skeletal, Urologic, and Vascular. The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information. The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.
Device Description
The 6150 is a mainframe ultrasound system, used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The system is equipped with a LCD Color Display, a control panel and is capable of operating Linear, Convex, and Phased array probes. The modified 6150, with respect to the cleared version 6150 via K051308, K052805, K060827, K081386 and K091009, is due to the improvements of the system. These modifications, that do not affect the intended use or alter the fundamental scientific technology of the device, are the following: - a. New keyboard (control panel), where some control keys (knobs and keys) have been replaced by a touch screen. - b. New plastic housing of the system both to include the touch screen and to give a new style - c. New keyboard group PCBs lay out to interface the touch screen and to match the new organization of the panel keys. - Software/Firmware modification to translate the touch screen information for the d. software: main software characteristics and performances have not been changed. The 6250 is the model name of the modified 6150. The set of probes of the 6150 is exactly the same. The 6250 system is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.
More Information

K051308, K052805, K060827, K081386, K091009

K051308, K052805, K060827, K081386, K091009

No
The document describes a standard ultrasound system with a feature for image fusion from other modalities (CT/MR). There is no mention of AI or ML in the device description, intended use, or any performance study summaries. The modifications described are related to hardware (keyboard, housing) and software to support the new hardware, not advanced image analysis or processing using AI/ML.

No.
The device is described as a "diagnostic general ultrasound system" used to "perform diagnostic general ultrasound studies." Its intended uses, such as guiding biopsies and needle placement, are for diagnostic or procedural guidance rather than direct therapy.

Yes
The "Intended Use / Indications for Use" section explicitly states that the system is used to "perform diagnostic general ultrasound studies".

No

The device is described as a "mainframe ultrasound system" with physical components like a control panel, LCD display, and probes, indicating it is a hardware device with integrated software, not a software-only device.

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

Here's why:

  • IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device function: The description clearly states that the Esaote Model 6250 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
  • Virtual Navigator: While the Virtual Navigator uses images from other modalities (CT or MR), it is used during a clinical ultrasound session and the second modality image is explicitly stated as not intended to be used as a standalone diagnostic image. This further reinforces that the primary diagnostic function is based on the ultrasound imaging, not on in vitro testing.

The device is a medical imaging system used for in vivo diagnosis, not in vitro diagnosis.

N/A

Intended Use / Indications for Use

Esaote's Model 6250 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac. Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic. Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6250 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasound session. The second modality provides additional security in assessing the morphology of the ultrasound image.

Virtual Navigator can be used in the following application: Abdominal, Musculo-skeletal, Urologic, and Vascular.

The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an an additional source of information.

The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

Product codes

90IYN, 90IYO, 90ITX

Device Description

The 6150 is a mainframe ultrasound system, used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The system is equipped with a LCD Color Display, a control panel and is capable of operating Linear, Convex, and Phased array probes.

The 6150 system has been cleared by FDA via K051308, K052805, K060827, K081386 and K091009.

The modified 6150, with respect to the cleared version 6150 via K051308, K052805, K060827, K081386 and K091009, is due to the improvements of the system. These modifications, that do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

  • a. New keyboard (control panel), where some control keys (knobs and keys) have been replaced by a touch screen.
  • b. New plastic housing of the system both to include the touch screen and to give a new style
  • c. New keyboard group PCBs lay out to interface the touch screen and to match the new organization of the panel keys.
  • Software/Firmware modification to translate the touch screen information for the d. software: main software characteristics and performances have not been changed.

The 6250 is the model name of the modified 6150. The set of probes of the 6150 is exactly the same.

The 6250 system is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound, CT, MR

Anatomical Site

Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic, Urologic, Ophthalmic, Intraoperative Neurological, Breast, Thyroid, Testicles

Indicated Patient Age Range

Neonatal, Pediatric, Adult

Intended User / Care Setting

Not Found

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)

Not Found

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

Not Found

Predicate Device(s)

K051308, K052805, K060827, K081386, K091009

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

Esaote, S.p.A.

JAN - 7 2011

K103152 Special 510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 1807.92(a).

807.92(a)(1)

Submitter Information

Esaote S.p.A. Via Siffredi 58 Genoa, Italy 16153

Contact Person:

Allison Scott 317.569.9500 x106 ascott@ansongroup.com

Date:

October 22, 2010

807.92(a)(2)

Trade Name: 6250 System

Common Name: Ultrasound Imaging System

Classification Name(s):

Classification Number: 90IYN; 90IYO; 90ITX

807.92(a)(3)

Predicate Device(s)

Ultrasonic pulse Doppler imaging system 892.1550 Ultrasonic pulsed echo imaging system 892.1560

K051308, K052805, K060827, K081386 and K091009

6150

Esaote, S.p.A.

1

Esaote, S.p.A.

807.92 (a)(4)

Device Description

The 6150 is a mainframe ultrasound system, used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The system is equipped with a LCD Color Display, a control panel and is capable of operating Linear, Convex, and Phased array probes.

The 6150 system has been cleared by FDA via K051308, K052805, K060827, K081386 and K091009.

The modified 6150, with respect to the cleared version 6150 via K051308, K052805, K060827, K081386 and K091009, is due to the improvements of the system. These modifications, that do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

  • a. New keyboard (control panel), where some control keys (knobs and keys) have been replaced by a touch screen.
  • b. New plastic housing of the system both to include the touch screen and to give a new style
  • c. New keyboard group PCBs lay out to interface the touch screen and to match the new organization of the panel keys.
  • Software/Firmware modification to translate the touch screen information for the d. software: main software characteristics and performances have not been changed.

The 6250 is the model name of the modified 6150. The set of probes of the 6150 is exactly the same.

The 6250 system is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

807.92(a)(5) :

, -

Intended Use(s)

Esaote's Model 6250 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac. Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic. Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6250 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

2

Special 510(k) Summary 6250 System Esaote, S.p.A.

The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasound session. The second modality provides additional security in assessing the morphology of the ultrasound image.

Virtual Navigator can be used in the following application: Abdominal, Musculo-skeletal, Urologic, and Vascular.

The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information.

The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

807.92(a)(6)

Technological Characteristics

The modifications reflected in this Special 510(k) for the 6250 are intended to improve the system's performance. The modifications have not altered the fundamental scientific technology or the intended use of the unmodified version of the 6150 cleared via K051308, K052805, K060827, K081386 and K091009.

3

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.

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

Esaote S.p.A. % Ms. Allison Scott, RAC Regulatory Associate Anson Group 11460 N. Meridian Street, Suite 150 CARMEL IN 46032

JAN - 7 2011

Re: K103152 Trade/Device Name: 6250 Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: October 22, 2010 Received: October 26, 2010

Dear Ms. Scott:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the 6250 Ultrasound Systems, as described in your premarket notification:

Transducer Model Number
PA230LA532CA631TEE022
PA122LA9322CWTEE022
PA023C5-2R135CWIOE323
PA240CA123HF CWLP323
LA332CA421EC123BC431
LA435CA621EC1123.BL433
LA522CA430EC1123
LA523CA431BE1123

4

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

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

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

Sincerely yours

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

5

Model 6250

JAN - 7 2011

Indications for Use

510(k) Number (if known):

Device Name:

6250 Ultrasound Systems

Esaote's Model 6250 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6250 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasound session. The second modality provides additional security in assessing the morphology of the ultrasound image.

Virtual Navigator can be used in the following application: Abdominal, Musculo-skeletal, Urologic, and Vascular.

The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information.

The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

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

Over-The-Counter Use (21 CFR 807 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

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K103152

6

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (PD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
OphthalmicPPPPPPPPP5,6,7,8, 12, 13
FetalPPPPPPPPP5, 6, 7, 8, 12, 13
AbdominalPPPPPPPPP5, 6, 8, 12, 13
Intraoperative (Abdominal)PPPPPPPPP5, 6, 7, 8, 12, 13
Intraoperative NeurologicalPPPPPPPPP5, 6, 7, 8, 12, 13, 14
PediatricPPPPPPPPP5, 6, 8, 12
Small Organ [1]PPPPPPPPP5, 6, 7, 8, 12
Neonatal CephalicPPPPPPPPP(15)5,6,7,8, 10, 11, 12
Adult CephalicPPPPPPPPP5, 6, 8, 10, 11, 12
Cardiac [2]PPPPPPPPP5, 6, 7, 8, 12, 13, 14
Transesophageal (Cardiac)PPPPPPPPP5, 6, 7, 8, 12, 13
Transesophageal (Non Cardiac)PPPPPPPPP5, 6, 7, 8, 12, 13
TransrectalPPPPPPPPP5,6,7, 8, 12, 13, 14
TransvaginalPPPPPPPPP5, 6, 7, 8, 12, 13, 14
TransurethralPPPPPPPPP5.6, 7, 8, 12, 13
IntravascularPPPPPPPPP5.6, 7, 8, 12, 13
Peripheral VascularPPPPPPPPP5.6, 7, 8, 12, 13
LaparoscopicPPPPPPPPP5.6, 7, 8, 12, 13
Musculo-skeletal ConventionalPPPPPPPPP5.6, 7, 8, 12, 13
Musculo-skeletal Superficial [3]PPPPPPPPP5.6, 7, 8, 12, 13
Other (Urological)PPPPPPPPP5.6, 7, 8, 12, 13
: New indication; P: Previously cleared by FDA: E:Added under Appendix E

ાં મુખ્યત્વે મકામ ગ od imaging or 6250 (Modified 6150)
Intended use: Discostic ultrass

1.) Small Organs includes:

|1] Small Organs includes
Breast, Thyroid and Testicles

|2| Cardiac is Adult and Pediatric

|4| Combined modes are:
B+M+PW+CW+CPM+PD
|5| Compass M-Mode (CMM) |2| Cardiac is Adult and
Pediatric
|3| Musculo Skeletal - Nerve
Block

613D
14D

1714D
[18] Уран

|8| Урап
|9| Xview

[9] Xview:
[10] Stress

[0] Matrix
[10] Stress
[11] XStrain

[10] Stress
[11] Xstrain
[12] Compound Imaging

|13| Trapezoidal View (TP-View)
|14| Elastography

ा से ही स्थान

Previously cleared via K051308,
K052805, K060827, K081386
and K091009

Prescription Use Only Per 21 CFR 801 Part D Concurrence

(Division Sign-Off)
Division of Radiological Devices

YH35152
510K

7

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Mode of Operations
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (PD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
OphthalmicPPPPPPPPP5, 6, 9
FetalPPPPPPPPP5, 6, 9
AbdominalPPPPPPPPP5, 6, 9
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPPP5, 6, 9
Small Organ [1]
Neonatal Cephalic
Adult CephalicPPPPPPPPP5, 6, 9
Cardiac [2]PPPPPPPPP(16)5, 6, 9, 10, 11
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPPP5, 6, 9
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)

New indication; P: Previously cleared by FDA; E:Added under Appendix N

[1] Small Organs includes
Breast, Thyroid and Testicles

|2] Cardiac is Adult and Pediatri

|3) Musculo Skeletal • Nerv
Block

(Division of Faction Sign-Off)

K103152

510K-

(4| Combined modes are:
B+M+PW+CW+CW+CFM+PD
[5] Compass M-Mode (CMM)

Total XView
Total Stress

110| stress
111| X strain

(6) 3D
(9) XV (vew
(1) V Strees
(1) ) Harburg sontrast (GaTI) in Adult Cardiac for left ventricle opacification of
visualization of the left ventricular endocardial bord

Previously cleared via k10093

PA230

Intended use: Dia

8

Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (PD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
Ophthalmic
Fetal
AbdominalPPPPPPPP5,6,9
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP5,6,9
Small Organ [1]
Neonatal CephalicPPPPPPPP5,6,9
Adult Cephalic
Cardiac [2]PPPPPPP5, 6, 9, 10, 11
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP5,6,9
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)

PA122
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

New indication; P. Previously cleared by FDA: E:Added under Appen N:

100

[1] Small Organs includes
Breast, Thyroid and Testicles

[2] Cardiar is Adult and
Pediatric
[3] Musculo Skeletal - Nerve
Block

|4| Combined modes are:
|5| Combined M-Mode |CMM)
|5| Comment M-Mode |CMM |
|6| STD
|0| XViews
|11| XViews
|111| Xartrain

[5] Compress M-Mode | Color
(6) 3D

[9] XView
[110] Stress

$\sigma*{11}$ stress
$\epsilon*{11}$ Xstrain

Previously cleared via k10043

Prescription Use Only Per 21 CFR 801 Part D
concurrence of CDRH, Office of In Vitro Diagnostic

K16352
10K

Sign-Off Radiological Devices

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

510K
K103153

9

PA023

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

Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (PD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPP5, 6, 9
Small Organ [1]
Neonatal CephalicPPPPPPP5, 6, 9
Adult Cephalic
Cardiac [2]PPPPPPP5, 6, 9, 10, 11
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPP5, 6, 9
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes
Breast, Thyroid and Testicles

i ediatrit
|3| Musculo Skeletal - Nerve
Block |2| Cardiac is Adult and
Pediatric

|3| Module Block
|4| Combined modes are:

B+M+PW+CW+CFM+PD

151 Compass M-Mode ICM

lal Combined model are:
JSI Gembers M-Mode (CMM)
JST Gembers M-Mode (CMM)

Previously cleared via K100931

(Division Sign-Off)
Division of Radiological Device

510K
Y163152

Prescription Use Only Per 21 CFFR 801 Part D
Concurrence of CDRH, Office of In Vitro

10

PA 240
Intended use: Diagnostic ultrasound imaging or fluíd flow analysis of human body as follows of Ollows

| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler
(PD) | Combined
[4] | Color Velocity
Mapping (TVM) | Harmonic
Imaging (TEI) | Other
(specify) |
|-----------------------------------|---|---|-----|-----|------------------|------------------------------|-----------------|---------------------------------|---------------------------|--------------------|
| Ophthalmic | P | P | P | P | P | P | P | | P | 5, 6, 9 |
| Fetal | P | P | P | P | P | P | P | | P | 5, 6, 9 |
| Abdominal | P | P | P | P | P | P | P | | P | 5, 6, 9 |
| Intraoperative (Abdominal) | P | P | P | P | P | P | P | | P | 5, 6, 9 |
| Intraoperative Neurological | P | P | P | P | P | P | P | | P | 5, 6, 9 |
| Pediatric | P | P | P | P | P | P | P | | P | 5, 6, 9 |
| Small Organ [1] | P | P | P | P | P | P | P | | P | 5, 6, 9 |
| Neonatal Cephalic | P | P | P | P | P | P | P | | P | 5, 6, 9 |
| Adult Cephalic | P | P | P | P | P | P | P | | P | 5, 6, 9 |
| Cardiac [2] | P | P | P | P | P | P | P | | P (16) | 5, 6, 9, 10, 11 |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | 5, 6, 9 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |

patient

[1] Small Organs includes
Breast, Thyroid and Testicles

$
\frac{1}{2}$

(2) Cardiac is Adult and
Pediatsic

realinks
|3| Musculo Skeletal - Nerve
Block

|4] Combined modes are:
B+M+PW+CW+CFM+PD
|5] Compass M-Mode (CMM)

B+M+PW+CW+CFM+
[5] Compass M-Model
[6] 3D
[a] Yirivu

רו אינט אינטייליג וואס שיינוש שניי
1972 - 1972 - 1972 - 1972 - 1972 - 1972 - 1972 - 1972 - 1972 - 1972 - 1972 - 1972 - 1972 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1972

[16] Includes contrast (CuTI) in Adult Cardiac for left ventricle opacification and
visualization of the lett ventricular endocardial border

Previously cleared via K100931

(Division Sign-Off)

(Division Sign-Off)

510K
K163132

Prescription Use Only Per 21 CFFR 801 Part D
Concurrence of CDRH, Office of In Vitro

11

Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (PD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
OphthalmicPPPPPPP
FetalPPPPPPP
AbdominalPPPPPPPP6, 8, 9, 12, 13
Intraoperative (Abdominal)PPPPPPPP6, 8, 9, 12, 13
Intraoperative Neurological
PediatricPPPPPPPP6, 8, 9, 12, 13
Small Organ [1]PPPPPPPP6, 8, 9, 12, 13, 14
Neonatal CephalicPPPPPPPP6, 8, 9, 12, 13
Adult Cephalic
Cardiac [2]PPPPPPPP6,8, 9, 10, 12, 12, 13
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP6, 8, 9, 12, 13
Laparoscopic
Musculo-skeletal Conventional [3]PPPPPPPP6, 8, 9, 12, 13, 14
Musculo-skeletal Superficial [3]PPPPPPPP6, 8, 9, 12, 13, 14
Other (Urological)PPPPPPPP6, 8, 9, 12, 13

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

|1| Small Organs includes
Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

(12) Compound Imaging (Mview)
(13) Trapezoidal View (TP-View )
(14) Elastography [3] Musculo Skeletal - Nerve [4] Combined modes are:
B+M+PW+CFM+PD | 1 | Strain |10] Stress |8] Vpan
|9| XView |6] 3D Block

Sign-Off Rediclosion Sign-Off
Division of Rediclorical Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

ਨਾਲ ਡਾ 22 2

510K-

Previously cleared via K100931

LA332

12

Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (PD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
OphthalmicP
FetalPPPPPP6, 8, 9, 12, 13
AbdominalPPPPPPP6, 8, 9, 12, 13
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPP6, 8, 9, 12, 13
Small Organ [1]PPPPPPP6, 8, 9, 12, 13, 14
Neonatal CephalicPPPPPPP6, 8, 9, 12, 13
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPP6, 8, 9, 12, 13
Laparoscopic
Musculo-skeletal ConventionalPPPPPPP6, 8, 9, 12, 13, 14
Musculo-skeletal Superficial [3]PPPPPPP6, 8, 9, 12, 13, 14
Other (Urological)PPPPPPP6, 8, 9, 12, 13

L.A.435
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

New indication; P: Previously cleared by FDA; E:Added under Append :

| I ] Small Organs includes
Breast, Thyroid and Testicles

(6) Vpan
(8) Vpan
(9) X Componind Imaging (Mview)
(13) Trapezoidal View (TP-View (TP-View )
(14) Elrastography |3] Musculo Skeletal - Nerve
Block |4] Combined modes are:
B+M+PW+CFM+PJ) |2] Cardiac is Adult and
Pediatric

Previously cleared via k10093

(Division Sign-Off)

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

510K
H163152

escription Use Only Per 21 CFFR 801 Part D
Concurrence of CDRH, Office of In Vitro

13

| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler
(PD) | Combined
[4] | Color Velocity
Mapping (TVM) | Harmonic
Imaging (TEI) | Other (specify) |
|----------------------------------|---|---|-----|-----|------------------|------------------------------|-----------------|---------------------------------|---------------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Abdominal | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Small Organ [1] | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13, 14 |
| Neonatal Cephalic | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Adult Cephalic [2] | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13, 14 |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |
| Other (Urological) | P | P | P | | P | P | P | | P | 6, 8, 9, 12, 13 |

i ટ ultr nostic LA522
Intended use: Diag New indication; P; Previously cleared by FDA; E:Added under Append 2

|l | Small Organs includes
Breast, Thyroid and Testicles

|2] Cardiac is Adult and Pediati

|3) Musculo Skeletal - Nerv
Block [4] Combined modes are
[3+M+PW+CFM+]*D

|6) Vipan
|8| Vipan
|9| Viewspound Imaging |Mriew
|13| Timpeoind View [TP-View
|14| Trapeosidal View [TP-View
|14| Elastography

Previously cleared via k10093

ర പ്രശ്ചാട 510K-

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

14

Extended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:Mode of Operations
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other (specify)
OphthalmicPPPPPP
RetalPPPPPPP6, 8, 9, 12, 13
AbdominalPPPPPPP6, 8, 9, 12, 13
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP6, 8, 9, 12, 13
Small Organ [1]PPPPPPPP6, 8, 9, 12, 13, 14
Neonatal CephalicPPPPPPP6, 8, 9, 12, 13
Adult Cephalic
Cardiac [2]PPPPPPP6, 8, 9, 10, 12, 12, 13
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP6, 8, 9, 12, 13, 14
Laparoscopic
Musculo-skeletal ConventionalPPPPPPPP6, 8, 9, 12, 13, 14
Musculo-skeletal Superficial [3]PPPPPPPP6, 8, 9, 12, 13, 14
Other (Urological)PPPPPPP6, 8, 9, 12, 13

or flu ostic ultrasound imaging oo: Dia LA523

New indication; P: Previously cleared by FDA; E:Added under Append

[1] Small Organs includes
Breast, Thyroid and Trsticle

[2] Cardiac is Adult and
Pediatric
[3] Musculo Skeletal - Nerve
Block

[3] Brachial Plexus Nerve
Block
[4] Combined modes are:
P+M+PW/"C"+M+PD

[10] Stress
[11] Strain
[12] Compound Imaging (Mview)
[13] Trapezoidal View (TP-View)
|14| Elastography

Previously cleared via k10093

(Division Sign-Off)

(Division Sign-Off)

510K
7163153

Prescription Use Only Per 21 CFR 801 Parl D
oncurrence of CDRH, Office of In Vitro Diagnost

15

| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler
(PD) | Combined
[4] | Color Velocity
Mapping (TVM) | Harmonic
Imaging (TEI) | Other (specify) |
|----------------------------------|---|---|-----|-----|------------------|------------------------------|-----------------|---------------------------------|---------------------------|-----------------|
| Ophthalmic | P | P | P | P | P | P | P | P | P | 6, 8, 9, 12, 13 |
| Abdominal | P | P | P | P | P | P | P | P | P | 6, 8, 9, 12, 13 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | 6, 8, 9, 12, 13 |
| Small Organ [1] | P | P | P | P | P | P | P | P | P | 6, 8, 9, 12, 13 |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | 6, 8, 9, 12, 13 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | 6, 8, 9, 12, 13 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | 6, 8, 9, 12, 13 |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P | P | 6, 8, 9, 12, 13 |
| Other (Urological) | P | P | P | P | P | P | P | P | P | 6, 8, 9, 12, 13 |

LA532
Intended use: Diagnostic ultrasound imaging of fluid flow analysis of human body as follow

New indication; P: Previously cleared by FDA; E:Added under Appendix

[1] Small Organs includes
Breast, Thyroid and Testicles

|3] Musculo Skeleta! - Nerve (4) Combined modes arc:
B+M+PW+CFM+PD [2] Cardiac is Adult and
Pediatric (6) 3D Block

[8] Vpan
[9] XView
[12] Compound Imaging (Mview)
[13] Trapezoidal View (TP-View J

Previously cleared via K091009

(Division Sign-Off)

(Division of Fadiological Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices Eveluation and Safety

510K-
K103153

16

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Mode of Operations
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other (specify)
OphthalmicPPPPPP
FetalPPPPPPP6, 8, 9, 12, 13
AbdominalPPPPPPP6, 8, 9, 12, 13
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPP6, 8, 9, 12, 13
Small Organ [1]PPPPPPP6, 8, 9, 12, 13
Neonatal CephalicPPPPPPP6, 8, 9, 12, 13
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPP6, 8, 9, 12, 13
Laparoscopic
Musculo-skeletal ConventionalPPPPPPP6, 8, 9, 12, 13
Musculo-skeletal Superficial [3]PPPPPPP6, 8, 9, 12, 13
Other (Urological)PPPPPPP6, 8, 9, 12, 13
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

ni LA923
Intended i

[1] Small Organs includes
Breast, Thyroid and Testicles

[2] Cardiae is Adult and
Pediatric

[3] Musculo Skeletal - Nen
Block [4] Combined modes are:
B+M+PW+CFM+PD

5] 3D
8] Vpan
1] XYView

[6] Vpan
[8] Vpan
[9] XView
[12] Clompound Imaging (Mview [

reviously cleared via k10093

1

Sign-Off (Division Sign-Off)

R1035153
510K

scription Use Only Per 21 CFR 801 Part
Concurrence of CDRH, Office of In Vitro

17

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical ApplicationMode of OperationsColor Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other (specify)
BMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]
OphthalmicPPPPPP
FetalPPPPPPP5, 6, 8, 9, 12
AbdominalPPPPPPP5, 6, 8, 9, 12
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPP5, 6, 8, 9, 12
Small Organ [1]PPPPPPP5, 6, 8, 9, 12
Neonatal Cephalic
Adult Cephalic
Cardiac [2]PPPPPPP5, 6, 8, 9, 10, 11, 12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPP5, 6, 8, 9, 12
Laparoscopic
Musculo-skeletal ConventionalPPPPPPP5, 6, 8, 9, 12
Musculo-skeletal Superficial [3]PPPPPPP5, 6, 8, 9, 12
Other (Urological)PPPPPPP5, 6, 8, 9, 12

n hortv as foll C5-2R13
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of hu

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

|1] Small Organs includes
Breast, Thyroid and Testicles

|2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[5] Compass M-Mode (CMM) (4) Combined modes are:
B+M+PW+CFM+PD (6) 3D

[8] Vpan

[1] Xstrain [10] Stress |9] XView

[12] Compound Imaging (Mview)

Previously cleared via K100931

(Division Sign-Off)
Division of Radiological Devices

Sign of the Off (Division Sign-Off)

510K
7163152

18

tended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical ApplicationMode of OperationsOther (specify)
RMPWDCWDColor DopplerAmplitude Doppler (PD)Combined [4]Color Velocity Mapping (TVM)
OphthalmicPPPPPPPP5, 6, 8, 9, 12
FetalPPPPPPPP5, 6, 8, 9, 12
AbdominalPPPPPPPP5, 6, 8, 9, 12
Intraoperative (Abdominal)
Intraoperative NeurologicalPPPPPPPP5, 6, 8, 9, 12
Pediatric
Small Organ [1]PPPPPPPP5, 6, 8, 9, 12
Neonatal CephalicPPPPPPPP5, 6, 8, 9, 12
Adult Cephalic
Cardiac [2]PPPPPPPP5, 6, 8, 9, 10, 11, 12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP5, 6, 8, 9, 12
Laparoscopic
Musculo-skeletal ConventionalPPPPPPPP5, 6, 8, 9, 12
Musculo-skeletal Superficial [3]PPPPPPPP5, 6, 8, 9, 12
Other (Urological)

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes
Breast, Thyroid and Testicles

[2] Cardiar is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

|5| Compass M-Mode (CMM) |4] Combined modes are:
|3+M+PW+CFM+PD ાદી રહ્યા

RIPSES

210K-

|8] Vpan
[9] XView
[10] Stress

(11) Xstrain
[11] Xstrain
[12] Compound Imaging (Mview)
[12] Compound Imaging (Mview)

Previously cleared via K100931

n: CA123

19

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (PD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
OphthalmicPPP
FetalPPPPPPPP5, 6, 8, 9, 12
AbdominalPPPPPPPP5, 6, 8, 9, 12
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP5, 6, 8, 9, 12
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP5, 6, 8, 9, 12
Laparoscopic
Musculo-skeletal ConventionalPPPPPPP5, 6, 8, 9, 12
Musculo-skeletal Superficial [3]PPPPPP5, 6, 8, 9, 12
Other (Urological)PPPPPPP5, 6, 8, 9, 12
: New indication; P: Previously cleared by FIDA; E:Added under Appendix E

ise: Dia CA421
Intended u

[1] Small Organs includes
Breast, Thyroid and Testicles

[2] Cardiat is Adult and Pediatric

[3] Musculo Skeletal - Nerve
Block

[4] Combined modes are:
[3] ComVotGJ M-Mode (CMM)
[6] Storitioners M-Mode (CMM)
[6] Stillings M-Modelne (Mview)

[12] Compound Imaging (Micr

Previously cleared via K091009

(Division Sign-Off)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Devices

510K
K103152

Prescription Use Only Per 21 CFR 801 Part D
Concurrence of CDRH, Office of In Vitro Diagnostics

20

ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:Mode of Operations
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
(specify)
OphthalmicPPPPPPPPP5, 6, 8, 9, 12
RectalPPPPPPPPP5, 6, 8, 9, 12
AbdominalPPPPPPPPP5, 6, 8, 9, 12
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP5, 6, 8, 9, 12
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPPP5, 6, 8, 9, 12
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]

5, 6, 8, 9, 12

Other (Urological)
N: New indication; P: Previously cleared by FDA; E:Added under Append

[1] Small Organs includes
Breast, Thyroid and Testicles

|2) 2011
|6| 3 | Vpan
|8| X View
|12| Compound Imaging (Mview |4] Combined modes are:
B+M+PW+CFM+PD
|5J Compass M-Mode (CMM) [2] Cardiae is Adult and
Pediatric
[3] Museulo Skeletal - Nerve
Hock

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

్ర

राष्ट्रगत

510K-

Previously cleared via k09100

scription Use Only Per 21 CFFR 801 Part
Concurrence of CDRH, Office of In Vitro

6 CA621 andad i

21

| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler
(PD) | Combined
[4] | Color Velocity
Mapping (TVM) | Harmonic
Imaging (TEI) | Other (specify) |
|----------------------------------|---|---|-----|-----|------------------|------------------------------|-----------------|---------------------------------|---------------------------|------------------------|
| Ophthalmic | P | P | P | P | P | P | P | P | P | 5, 6, 8, 9, 12 |
| Fetal | P | P | P | P | P | P | P | P | P | 5, 6, 8, 9, 12 |
| Abdominal | P | P | P | P | P | P | P | P | P | 5, 6, 8, 9, 12 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | 5, 6, 8, 9, 12 |
| Small Organ [1] | P | P | P | P | P | P | P | P | P | 5, 6, 8, 9, 12 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | P | P | P | P | P | P | P | P | P(16) | 5, 6, 8, 9, 10, 11, 12 |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | 5, 6, 8, 9, 12 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | 5, 6, 8, 9, 12 |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P | P | 5, 6, 8, 9, 12 |
| Other (Urological) | P | P | P | P | P | P | P | P | P | 5, 6, 8, 9, 12 |

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: CA430

N: New indication; P: Previously cleared by FDA; E:Added under Appendix

[I] Small Organs includes
Breast, Thyroid and Testicles

[2] Cardia: is Adult and Pediatric

=

=

=

|3| Musculo Skeletal - Nerve
Block

|8] Vpan
|9] XView
|10] Stress
|11] Xstrain
|12] Compound Imaging (Mview) [5] Compass M-Mode (CMM) (4) Combined modes are:
B+M+PW+CFM+PD (6) 3D

  1. Compound Imaging (Myview)

[16] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and
visualization of the left ventricular endocardial border

Previously cleared via K100931

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

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

S10K
7103152

22

Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (PD)Combined {4}Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
OphthalmicPPPPPPPPP
FetalPPPPPPPPP5, 6, 8, 9, 12
AbdominalPPPPPPPPP5, 6, 8, 9, 12
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPPP5, 6, 8, 9, 12
Small Organ [1]PPPPPPPPP5, 6, 8, 9, 12
Neonatal Cephalic
Adult Cephalic
Cardiac [2]PPPPPPPPP(16)5, 6, 8, 9, 10, 11, 12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPPP5, 6, 8, 9, 12
Laparoscopic
Musculo-skeletal Conventional [3]PPPPPPPPP5, 6, 8, 9, 12
Musculo-skeletal Superficial [3]PPPPPPPPP5, 6, 8, 9, 12
Other (Urological)PPPPPPPPP5, 6, 8, 9, 12

[1] Small Organs includes
Breast, Thyroid and Testicles

Breast, Thyroid and Testicles

[2] Cardiac is Adult and
Prdiatric

[3] Musculo Skeletal - Nerve
Block

Block

[4] Combined modes are:
B+M+PW+CFM+PD

B+M+PW+CF+M+PU
[5] Compass M-Mode

|5) Compass M-Mode (CMM)

[S] Compass M-M K13D

៤] នរា

|cr|
|8|
Vpan

la Maria Malaysia
May 2018 kishi
May 2018 kishi
Maydoni (18) Maydoni (18)

plXview

plaxis
soiltest

| 12| Compound Imaging (Mview)

[16] Includes contrast (CnTI) in Adult Cardine for left ventricle opacification and

Previously cleared via K100931

(Division Sign-Off)
Division of Radiological Devices

Division Sign-Of Radiological Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices Evaluation and Safety

K10353
510K

23

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Mode of Operations
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (PD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
OphthalmicPPPPPPP
FetalPPPPPPPP5, 6, 8, 9, 12
AbdominalPPPPPPPP5, 6, 8, 9, 12
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP5, 6, 8, 9, 12
Small Organ [1]PPPPPPPP5, 6, 8, 9, 12
Neonatal Cephalic
Adult Cephalic
Cardiac [2]PPPPPPPP5, 6, 8, 9, 10, 11, 12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP5, 6, 8, 9, 12
Laparoscopic
Musculo-skeletal Conventional [3]PPPPPPPP5, 6, 8, 9, 12
Musculo-skeletal Superficial [3]PPPPPPPP5, 6, 8, 9, 12
Other (Urological)PPPPPPPP5, 6, 8, 9, 12

nia oded use: CA631 C under Apper E:Added by FDA; cleared sly indication; P: Previou 2

[1] Small Organs includes
Breast, Thyroid and Testicles

[2] Cardiar is Adult and Pediatr

|6| 3D
|6| Vipm
|0| Sitevess
|11| Xastrain
|11| Xastrain
|12| Compound Imaging (Mview [4] Combined modes are:
B+M+PW+CFM+PD
[5] Compass M-Mode [CMM] (3) Musculo Skeletal - Nervi
Block

Previously cleared via k10093

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

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

510K
7103153

24

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows
Mode of Operations
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (PD)Combined (4)Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)P
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
IntravascularP
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes
Breast, Thyroid and Testicles

[2] Cardiac is Adult and
Pediatric

[3] Musculo Skeletal - Nerve
Block

[4] Combined modes are:

Previously cleared via K100931

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K: K103152
Prescription Use Only Per 21 CFR 801 Part D
Concurrence of CDRH, Office of In Vitro Diagnosticsended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:

2CW

25

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Mode of Operations
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (PD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
[1] Small Organs includes
Breast, Thyroid and Testicles
[2] Cardiac is Adult and
Pediatric
[3] Musculo Skeletal - Nerve
Block
[4] Combined modes arc:510K.K103152

Previously cleared via K100931

5CW

26

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler (PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularP
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (PD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
Ophthalmic
TotalPPPPPPPP5, 6, 8, 9, 12
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
TransrectalPPPPPPPP5, 6, 8, 9, 12
TransvaginalPPPPPPPP5, 6, 8, 9, 12
TransurethralP
Intravascular-
Peripheral VascularPPPPPP5, 6, 8, 9, 12
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)PPPP5, 6, 8, 9, 12

N: New indication; P: Previously cleared by FDA; E:Added under Appendix Other (Urological)

[1] Small Organs includes
Breast, Thyroid and Testicles

[3] Musculo Skeletal - Nerve [4] Combined modes arc: [2] Cardiac is Adult and
Pediatric Block

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

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

510K
AI03153

Previously cleared via K100931

HF CW

27

body as of hu analvsis or fluid flow 1 altr Diaanostic EC123
Intended use:

er (Orological)
New indication; P: Previously cleared by FDA; E:Added under Appendix 1

(1) Small Organs includes
Breast, Thyroid and Testicles

(6) 3D
[8] Vpan
[9] XView
[12] XView
[12] Compound Imaging (Mview) [2] Cardiac is Adult and
Pediatric
[3] Musculo Skeletal - Nerve
Block [4] Combined modes are:
B+M+PW+CFM+PD
[5] Compass M-Mode (CMM)

reviously cleared via k10093

(Division Sign-Off)
Division of Radiological Devices

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

510K
763156

28

tended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:Mode of Operations
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other (specify)
OphthalmicPPP
FetalPPP5, 6, 8, 9, 12
AbdominalPPPPP
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
TransrectalPPPPPPPP5, 6, 8, 9, 12, 14
TransvaginalPPPPPPPP5, 6, 8, 9, 12
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)PPPPPPPP5, 6, 8, 9, 12

body as foll analysis of hu ar fluid flow EC1123
Intended use: Diagnostic

New indication; P: Previously cleared by FDA; E:Added under Appendix N:

|1] Small Organs includes
Breast, Thyroid and Testicles

|6] 3D
|6] Vpan
|0] XView
|12| XView
|12| Compound Imaging (Mview)
|14| Elastography [5] Compass M-Mode (CMM) [3] Musculo Skeletal - Nerve [4] Combined modes are:
B+M+PW+CFM+PD |2] Cardiac is Adult and Pediatric Block

[14] Elastography

Previously cleared via K100931

(Division Sign-Off)
Division of Radiological Devices

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

510K
K103153

29

tended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Mode of Operations
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Harmonic
Imaging (TEI)Harmonic
Imaging (TEI)Other (specify)
Ophthalmic
etal
bdominal
ntraoperative (Abdominal)
ntraoperative Neurological
ediatric
mall Organ [1]
eonatal Cephalic
dult Cephalic
Cardiac [2]
ansesophageal (Cardia
ransesophageal (Non Cardia
ransrectalPPPPPPPP5, 6, 8, 9, 12, 13, 14
ransvaginalPPPPPPPP5, 6, 8, 9, 12, 13, 14
ransurethra,
ntravascular
eriphera! Vascular
aparoscopi
fusculo-skeletal Conventiona
(દ
Ausculo-skeletal Superficia
Other (UrologicalPPPPPPPP5, 6, 8, 9, 12, 13

of human or fluid flow analysis ાતા તાલુકામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપા nostic ultrasor EC1123
Intended use: Diag

New indication; P: Previously cleared by FDA; E:Added under Apper

|1] Small Organs includes
Breast, Thyroid and Testicles

(6) 3D
(8) Vipan
(9) X View
(9) X Viewpound Imaging (Mriew)
(113) Transessional view (TPView)
(114) Elastography |2] Cardiac is Adult and
Pediatric
[3] Musculo Skeletal - Nerve
Block (4) Combined modes are:
B+M+PW+CFM+FD
(5) Compass M-Mode (CMM)

Previously cleared via k10093

(Division Sign-Off)
Division of Radiological Devices

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

( 10355 510K-

scription Use Only Per 21 CFFR 801 Park
Concurrence of CDRH, Office of In Vitro

30

| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler
(PD) | Combined
[4] | Color Velocity
Mapping (TVM) | Harmonic
Imaging (TEI) | Other (specify) |
|----------------------------------|---|---|-----|-----|------------------|------------------------------|-----------------|---------------------------------|---------------------------|-------------------|
| Ophthalmic | | | | | | | | | | |
| Vasal | P | P | P | | P | P | P | P | P | 5, 6, 7, 8, 9, 12 |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | P | P | P | | P | P | P | P | P | 5, 6, 7, 8, 9, 12 |
| Transvaginal | P | P | P | | P | P | P | P | P | 5, 6, 7, 8, 9, 12 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | |
| Other (Urological) | P | | | | P | | | | | 5, 6, 7, 8, 9, 12 |

ntended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo BE1123

New indication; P: Previously cleared by FDA; E:Added under Appene

|1| Small Organs includes
Breast, Thyroid and Testicles

GJ Combined modes are:
[5] Compane M-Rode (CMM)
[6] Stompace M-Rode (CMM)
[6] Stompace M-Rede (CMM)
[6] Virginal Uninging (Mview |2] Cardiac is Adult and
Pediatric
|3] Musculo Skeletal - Nerve
Block

Previously cleared via k10093

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

S10K
K1C3153

Prescription Use Only Per 21 CFR 801 Part D
oncurrence of CDRH, Office of In Vitro Diagnosti

31

ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Mode of Operations
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (PD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]PPPPPPPP5, 6, 9, 10, 11
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)

TEE022

New indication; P: Previously cleared by FDA; E:Added under Append

[1] Small Organs includes
Breast, Thyroid and Testicles

[2] Cardiac is Adult and
Pediatric
[3] Musculo Skeletal - Nerve
Block [4] Combined modes are:
B+M+]'W+CFM+PD
[5] Compass M-Mode (CMM)

B+M+W+CFM+PD
[E] Gen. Med.

Sign-Off)

ర్య

KI0315

510K-

[5] Compass M-Mode
[6] 3D

11 Max 18 Maria
1847 Maria 1972 Mari 1972 Mari 1972 Mari 1972 Mari 1972 Mari 1972 Mari 1972 Mari 1972 Mari 1972 Mari 1972 Mari 1972 Mari 1972 Mari 1972 Mari 19

[I]xstream

Previously cleared via k10093

escription Use Only Per 21 CFR 801 Part
Concurrence of CDRH, Office of In Vitro

32

TEE022
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical ApplicationMode of OperationsOther (specify)
BMPWDCWDColor DopplerAmplitude Doppler (PD)Combined [4]Color Velocity Mapping (TVM)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]PPPPPPP5, 6, 9, 10, 11
Transesophageal (Cardiac)P
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)

N: New indication; P: Previously cleared by FDA; E:Added under Appendix

[1] Small Organs includes
Breast, Thyroid and Testicles

[2] Cardiac is Adult and

|3] Musculo Skeletal - Nervr |2] Cardiac is Adult and
Pediatric

Block

|4] Combined modes are:
B+M+I'W+CFM+FD

|5] Compass M-Mode (CMM)

(Division of Radiological Devices

103152

-(

510K-

g|3D
ouri

|6] XV
|9] XView
|10] Stress
|11| Kstrain

Prescription Use Only Per 21 CFFR 801 Part D
Concurrence of CDRH, Office of In Vitro

escription Use Only Per 21 CFR 801 Par
Concurrence of CDRH, Office of In Vitro

Previously cleared via K100931

33

Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (PD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
OphthalmicPPPPPPPPP6, 8, 9, 12, 13
FetalPPPPPPPPP6, 8, 9, 12, 13
AbdominalPPPPPPPPP6, 8, 9, 12, 13
Intraoperative (Abdominal)PPPPPPPPP6, 8, 9, 12, 13
Intraoperative Neurological
PediatricPPPPPPPPP6, 8, 9, 12, 13
Small Organ [1]PPPPPPPPP6, 8, 9, 12, 13, 14
Neonatal CephalicPPPPPPPPP6, 8, 9, 12, 13
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPPP6, 8, 9, 12, 13
Laparoscopic
Musculo-skeletal ConventionalPPPPPPPPP6, 8, 9, 12, 13
Musculo-skeletal Superficial [3]PPPPPPPPP6, 8, 9, 12, 13
Other (Urological)PPPPPPPPP6, 8, 9, 12, 13

ાં IOE323

New indication; P: Previously cleared by FDA; E:Added under Appendix 00

[1] Small Organs includes
Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve
Block [4] Combined modes are:
B+M+PW+CFM+PD

(6) 3D
(6) Vpan
(9) (1) (Cirmound (maging (Mview)
(13) (Crapeoida) View (TP-View J
(14) Elastography

Previously cleared via k10093

(Division Sign-Off)

Sign-Off (Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Dev

( 110315 510K_

Prescription Use Only Per 21 CFR 801 Part D
oncurrence of CDRH, Office of In Vitro Diagnostic

34

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other (specify)
Ophthalmic
FetalPPPPPPP
AbdominalPPPPPPP6, 8, 9, 12, 13
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]PPPPPPP6, 8, 9, 12, 13
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPP6, 8, 9, 12, 13
LaparoscopicPPPPP
Musculo-skeletal Conventional
[3]
Musculo-skeletal Superficial [3]
Other (Urological)

onak ાંત્ર ધાર્મિક ศ ... 1 -140 tic nis LP323
Intended t

New indication; P. Previously cleared by FDA; E:Added under Apper in

[1] Small Organs includes
Breast, Thyroid and Testicles

|6] 3D
|8] Vpan
|9| XView
|12| Clompound Imaging (Mview |
|13| Trapezoida) View (TP-View (TP-View ) |2] Cardiac is Adult and
Pediatric
|3] Musculo Skeletal - Nerve
Block |4] Combined modes are:
B+M+PW+CFM+PD

teviously cleared via k10093

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

రార کان جو توران جو پرور واقع واقع وال المورد والمورد والمورد والمورد والمورد والمورد والمورد والمورد والمورد والمورك الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الم 510K_

scription Use Only Per 21 CFR 801 Part
Concurrence of CDRH, Office of In Vitro

35

Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (PD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
OphthalmicPPPPPPPP5, 6, 7, 8, 9, 12
FetalPPPPPPPP5, 6, 7, 8, 9, 12
AbdominalPPPPPPPP5, 6, 7, 8, 9, 12
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPP5, 6, 7, 8, 9, 10, 11, 12
Laparoscopic
Musculo-skeletal Conventional [3]PPPPPP5, 6, 7, 8, 9, 12
Musculo-skeletal Superficial [3]PPPPPP5, 6, 7, 8, 9, 12
Other (Urological)PPPPPP5, 6, 7, 8, 9, 12

ultrasound imaging or fluid flow analysis of human body as BC431
Intended use: Diagnostic

New indication; P: Previously cleared by FDA; E:Added under Appen ద్

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[1] Small Organs includes Breast
Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

(3) Musculo Skeirial - Nerve
Block

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

6

1103152

.

510K-

[6] 3D
[7] 4D
[8] Vpan

[8] Itrd & Patt
[9] XView
[10] Super

[10] Stress
MAX. AT
VIEW

[11] Xstrain
[12] Compound Imaging

Previously cleared via K100931

36

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Mode of Operations
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other (specify)
OphthalmicPPPPPPPPP6, 7, 8, 9, 12, 13
FetalPPPPPPPPP6, 7, 8, 9, 12, 13
AbdominalPPPPPPPPP6, 7, 8, 9, 12, 13
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPPP6, 7, 8, 9, 12, 13
Small Organ [1]PPPPPPPPP6, 7, 8, 9, 12, 13
Neonatal CephalicPPPPPP6, 7, 8, 9, 12, 13
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPP6, 7, 8, 9, 12, 13
Laparoscopic
Musculo-skeletal Conventional [3]PPPPPPP6, 7, 8, 9, 12, 13
Musculo-skeletal Superficial [3]PPPPPP6, 7, 8, 9, 12, 13
Other (Urological)PPPPPP6, 7, 8, 9, 12, 13
POST CARTER FOR COLLECTION OF

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Intended u

New indication; P: Previously cleared by FDA; E:Added under Apper ੱਕ

L

[1] Small Organs includes
Breast, Thyroid and Testicles

[2] Cardiar is Adult and Pediatric

[3] Musculo Skeletal - Nerve

[6] 4D
[6] 4Dam
[8] View
[12] Claud
|12] Compound Imaging (Mriew)
|13] Trepezoidal view (TPView) |3| Musculo Skeletal - Nerve
Block [4] Combined modes are:
B+M+PW+CFM+PD

(Division Sign-Off)

C

410315

510K-

Previously cleared via k10093

Prescription
Use Only Per 21 CFR 801 Part D
ncurrence of CDRH, Office of In Vitro Diagnost