The DIAGNOSTIC ULTRASOUND SYSTEM APLIO MX MODEL SSA-780A is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).

Device Description

The DIAGNOSTIC ULTRASOUND SYSTEM APLIO XG MODEL SSA-780A is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.

AI/ML Overview

The provided FDA 510(k) Premarket Notification for the Toshiba Aplio™ MX (v1.0) SSA-780A Ultrasound System (K092948) does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a clinical performance study for an AI/CADe device would.

This document is a submission for a diagnostic ultrasound system, which falls under general controls and requires demonstration of substantial equivalence to a legally marketed predicate device. The information provided heavily focuses on intended use statements for various transducers and operational modes, rather than performance metrics like sensitivity, specificity, or reader improvement.

Therefore, many of the requested fields cannot be extracted or are not applicable in the context of this 510(k) submission for a general ultrasound system.

Here's a breakdown of the information that can be gleaned and what cannot:

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

This information is not present in the provided document in the form of specific quantitative acceptance criteria (e.g., minimum sensitivity/specificity) and corresponding reported device performance metrics. The document instead lists the clinical applications and modes of operation for various transducers, largely stating that these are "previously cleared by FDA" or "new indications" for specific modes. The "performance" is implicitly tied to substantial equivalence to the predicate device and compliance with relevant standards.

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

Not provided. This type of detail would typically be found in a clinical performance study report, which is not part of this 510(k) summary (or likely not required for a Class II ultrasound system that isn't a CADe device).

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

Not applicable/Not provided. Since there's no mention of a specific test set or ground truth establishment in a clinical performance study context, this information is not available.

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

Not applicable/Not provided. As there is no test set or ground truth establishment described, no adjudication method would be relevant or mentioned.

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

Not applicable/Not provided. The Aplio™ MX (v1.0) SSA-780A is a diagnostic ultrasound system, not an AI/CADe device that assists human readers. Therefore, an MRMC comparative effectiveness study with AI assistance would not be relevant.

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

Not applicable/Not provided. This device is a general diagnostic ultrasound system, not an algorithm.

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

Not applicable/Not provided. No explicit ground truth is mentioned for performance evaluation in a clinical study context. The substantial equivalence is based on the device's technical specifications and intended use being similar to predicate devices, and compliance with standards like IEC 60601-1 and AIUM-NEMA.

8. The sample size for the training set:

Not applicable/Not provided. There is no mention of an algorithm or a training set for machine learning in this submission.

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

Not applicable/Not provided. There is no mention of an algorithm or a training set for machine learning in this submission.

Summary of what is available in the document regarding "acceptance" (understood as compliance and intended use):

The document details the Intended Use for the Aplio™ MX (v1.0) SSA-780A Ultrasound System across various transducers and clinical applications. The "acceptance criteria" in this context are implicitly that the device is safe and effective for these indications, and that it is substantially equivalent to predicate devices. This equivalence is demonstrated by compliance with international standards and direct comparison of features and intended uses.

The study that proves the device meets these (implicit) acceptance criteria is the 510(k) submission itself, which argues for substantial equivalence. This is not a clinical performance study with quantitative results, but rather a regulatory demonstration based on technical specifications, intended uses, and compliance with recognized standards.

Implicit Acceptance Criteria (based on the document):

Conformance to Standards: The device is designed and manufactured in conjunction with Quality System Regulation, IEC 60601-1 (and its parts -1-1, -1-2, -1-4, -2-37), IEC 62304, AIUM-NEMA UD2, and AIUM-NEMA UD3.
Substantial Equivalence: The device is substantially equivalent to predicate devices (Toshiba DIAGNOSTIC ULTRASOUND SYSTEM APLIO XG MODEL SSA-790A v4.0R001 - K092179 and v4.0 - K091295) for shared indications and modes of operation.
New Indications Performance (implied): For "new indications" (marked with 'N' in the tables) or newly added modes/features, the implication is that their safety and effectiveness are established through standard ultrasound engineering verification, validation, and potentially pre-clinical or limited clinical evaluation to demonstrate they function as intended and do not raise new questions of safety or effectiveness compared to predicate devices for similar applications.

Reported Device Performance (based on the document, interpreted as intended capabilities):

The device performance is reported through the detailed "Intended Use" tables for the system and each transducer. These tables specify:

Clinical Applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Cardiac (Adult/Pediatric), Transvaginal, Transesophageal (non-Cardiac/Cardiac), Musculo-skeletal (Conventional/Superficial), Peripheral vessel, Trans-rectal.
Modes of Operation: B, M, PWD (Pulsed Wave Doppler), CWD (Continuous Wave Doppler), Color Doppler, Combined (e.g., B/M, B/PWD, BDF/PWD, BDF/MDF, BDF/MDF/PWD, 2D/CWD, BDF/CWD), THI (Tissue Harmonic Imaging), Dynamic Flow, Power, CHI 2D, 4D.
Other Features: TDI, ApliPure, MicroPure, Precision Imaging, STIC, 3D Color (Volume Color), STIC Color, Elastography.

The "P" (previously cleared) and "N" (new indication) markers in the tables indicate which clinical applications and modes have been previously cleared or are new to this device/submission.

In summary, for a diagnostic ultrasound system like the Aplio MX, "acceptance criteria are generally addressed through conformance to recognized standards, established intended uses, and demonstration of substantial equivalence to existing predicate devices, rather than through specific quantitative performance targets from dedicated clinical trials for each feature.

Summary

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

510{k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

K092948

510(k) Summary

OCT - 9 2009

Submitter's Name:	Toshiba America Medical Systems, Inc.
Address:	2441 Michelle Drive Tustin, CA 92780
Contact:	Paul Biggins, Director Regulatory Affairs
Telephone No .:	(714) 730-5000

Device Proprietary Name:

DIAGNOSTIC ULTRASOUND SYSTEM APLIO MX MODEL SSA-780A Version 1.0

Common Name:

Diagnostic Ultrasound System

Classification:

Regulatory Class: II .
Review Category: Tier II .
. Ultrasonic Pulsed Doppler Imaging System - Product Code: 90-IYN [Fed. Reg. No .: 892.1550]
Ultrasonic Pulsed Echo Imaging System Product Code: 90-IYO . [Fed. Reg. No .: 892.1560]
. Diagnostic Ultrasonic Transducer - Product Code: 90-ITX [Fed.Reg. No.: 892.1570]

Identification of Predicate Devices:

Toshiba America Medical Systems believes that this device is substantially equivalent to:

Toshiba DIAGNOSTIC ULTRASOUND SYSTEM APLIO XG MODEL SSA-790A 1. v4.0R001 - 510(k) K092179
Toshiba DIAGNOSTIC ULTRASOUND SYSTEM APLIO XG MODEL SSA-790A v4.0 -2. 510(k) K091295

Device Description:

Intended Use:

Declaration of Conformity:

This device is designed and manufactured in conjunction with the Quality System Regulation, IEC 60601-1 (applicable portions), IEC 60601-1-1 (applicable portion), IEC 60601-1-2 (applicable portion), IEC 60601-1-4 (applicable portion), IEC60601-2-37 (applicable portions), IEC 62304 (applicable portion) and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard.

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

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

OCT - 9 2009

Re: K092948

Trade/Device Name: Aplio MX v1.0 SSA-780A Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: September 23, 2009 Received: September 24, 2009

Dear Mr. Job:

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 Aplio MX v1.0 SSA-780A, as described in your premarket notification:

Transducer Model Number

PST-25BT	PVT-375MV	PVT-681MV
PST-30BT	PVT-382BT	PVT-745BTV
PST-50AT	PVT-382MV	PVT-770RT
PST-65AT	PVT-575MV	PLT-604AT
PST-20CT	PVT-674BT	PLT-704AT
PVT-375BT	PVT-661VT	PLT-704SBT

{2}------------------------------------------------

PLT-705BTH	PLT-1204A
PLT-705BTF	PLT-1204B
PLT-805AT	PLT-1204M
PLT-1202S	PET-510M

ਟ ਜਿ B

PET-508MA
PC-20M
PC-50M

If your device is classified (see above) into either class II (Special Controller)
it may be subject to such additional controls. Existing major regulations affective your d If your device is elassino (
it may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA
can be found in the Code of Feental Regulations, Title 21, Par it thay be stoget.
may publish further announcements concerning your device in the Federal Register.
may publish further announcements concerning your device in the Federal R

may publish untile and and Please be advised that FDA's issuance of a substantial equivalence of the Act
that FDA has made a determination that your device complies with of the Actives (21 Press of actives and regulations administered by other Foderal agencies. You must
that FDA has made a determination that such of coleral agencies. You must that FUA his made a works
or any Federal the Act regulations administered by other limited or resident of the many of the many of the may be as set of the setting of the seco or any redent states equirements, including, but not limited by tieststement as sed
CFR Part 807; labeling (21 CFR Part 80) ); good manufacturing practices and consected by a comply will an the Ace Part 801); good manufacturing practice todals and one of the electronic
CFR Part 807); abeling (21 CFR Part 801); and if applicable, the electronic
for CFR Part 607), March 3 (
forth in the quality systems (QS) regulation (21 CFR Part 820), and II approvinsions (2006).
product radiation control provisions (Sections 531-542

product taxiation on to begin marketing your device as described in your premarket.
This letter will of a line of substantial equivalence of your device to a legion to This letter will allow you to begin marketing your device in your device to a legally marketed
notification. The FDA finding of substantial equivalence of your device to I his telton. The FDA finding of substantial equivalence of your device to are a program.
predicate device results in a classification for your device and thus permits your proceed to market.

proceed to market.

If you desire specific advice for your device on our labeling regulation (11 CFR Part 801), please If you desire specific advice for your device on our labeling regulation (2) Control Concellent for for for for for for for for for for for for for alles pleases of the If you desire specifics and Radiological Health's (CDRH) office of Complexs
go to bittp://www.fdagogical Health's (CDRH's) Office of Company'' (2) CPF Pati
the Center for Dev go to bitp://www.fala.gov.com/ng by reference to premaket notification" (2) Prefer
the Center for Devices and, "Misbranding by reference to premarket notification" (2) (2) the United for Dorrest and

807.97). Por questions rogan o
CFR Part 803), please go to
http://www.fdc.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's Office
http://www.fdb.gov/ices CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/Nepostmarket Surveillance.

of Surveinalled and Dec.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.

Sincerely yours,

Heidi Lemun

Janine M. Morris Janine M. Morris
Acting Director, Division of Reproductive, Acting Director, Pradiological Devices Office of Device Evaluation Office of Device Evaruation
Center for Devices and Radiological Health

Enclosure(s)

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

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

System: __Aplio MX v1.0 SSA-780A Transducer:

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal	N	N	N	N	N	N	N	N	N	N	N	5,7,8,9,10
Abdominal	N	N	N	N	N	2,3	N	N	N	N	N	5,7,8,9,10
Intra-operative (Abdominal)	N	N	N	N	N	2	N	N	N			4,5
Intra-operative (Neuro)
Laparoscopic
Pediatric	N	N	N	N	N	2,3	N	N	N	N	N	5,7,8,9,10
Small Organ (Note 1)	N	N	N	N	N	2	N	N	N			4,5,6,7,9,1
Neonatal Cephalic	N	N	N	N	N	N	N	N	N
Adult Cephalic	N	N	N	N	N	3	N	N	N
Trans-rectal	N	N	N	N	N	2	N	N	N		N	4,5,7,11
Trans-vaginal	N	N	N	N	N	2	N	N	N		N	4,5,7
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)	N	N	N	N	N	2	N	N	N			4,5,6,7,9,1
Musculo-skeletal (Superficial)	N	N	N	N	N	2	N	N	N			4,5,6,7,9,1
Intravascular
Other (Specify)
Cardiac Adult	N	N	N	N	N	3	N	N	N	N		4
Cardiac Pediatric	N	N	N	N	N	3	N	N	N	N		4
Intravascular (Cardiac)
Trans-esoph. (Cardiac)	N	N	N	N	N	3	N					4
Intra-cardiac
Other (Specify)
Peripheral vessel	N	N	N	N	N	2	N	N	N			4,5,6,7,9,1
Other (Specify)

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

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging lim Note 8 STIC (Division Sign-Off) Note 9 3D Color (Volume Color) Division of Reproductive, Abdominal. Note 10 STIC Color and Radiological Device Note 11 Elastography

Prescription Use Only (Per 21 CRF801.109)

B-I

510(k) Number_

{4}------------------------------------------------

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

System: Aplio MX v1.0 SSA-780A Transducer:_ PST-25BT

. .

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	3	P	P	P
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	3	P	P	P
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	P	3	P	P	P
Adult Cephalic	P	P	P	P	P	3	P	P	P
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	P	3	P	P	P	P		4
Cardiac Pediatric	P	P	P	P	P	3	P	P	P	P		4
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD-Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI

Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging

Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography

Prescription Use Only (Per 21 CRF801.109)

Hleun
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devic

Radiological Devices
510(k) Number K092948

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

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

System: __ Aplio MX v1.0 SSA-780A Transducer: PST-30BT

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

Clinical ApplicationSpecific(Tracks 3)	B	M	PWD CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	Other[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	3	P	P	P
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	3	P	P	P
Small Organ (Specify) (1)
Neonatal Cephalic	P	P	P	P	3	P	P	P
Adult Cephalic	P	P	P	P	3	P	P	P
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	3	P	P	P	P	4
Cardiac Pediatric	P	P	P	P	3	P	P	P	P	4
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510{k) of the transducer: K092179

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 TDI
Note 5 ApliPure

Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography

Hlen

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device

510(k) Number K092

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

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

Aplio MX v1.0 SSA-780A System: Transducer:_ PST-50AT

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other(Note)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	P	3	P
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	P	3	P					4
Cardiac Pediatric	P	P	P	P	P	3	P					4
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging (Division Sign-Off) Note 8 STIC Division of Reproductive, Abdominal, Note 9 3D Color (Volume Color) and Radiological Devic Note 10 STIC Color Note 11 Elastography 510(k) Number

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

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

System: Aplio MX v1.0 SSA-780A Transducer:_ _PST-65AT

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	P	3	P	P	P
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	P	3	P	P	P			4
Cardiac Pediatric	P	P	P	P	P	3	P	P	P			4
IPtravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF; BD/CWD; BDF/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Our Note 7 Precision Imaging (Division Sign-Off) Note 8 STIC Division of Reproductive, Abdominal, Note 9 3D Color (Volume Color) and Radiological Device Note 10 STIC Color 510(k) Number Note 11 Elastography Prescription Use Only (Per 21 CRF801.109)

B-5

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

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

System: Aplio MX v1.0 SSA-780A Transducer: PST-20CT

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	3	P	P	P
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	3	P	P	P
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	P	3	P	P	P
Adult Cephalic	P	P	P	P	P	3	P	P	P
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	P	3	P	P	P	P		4
Cardiac Pediatric	P	P	P	P	P	3	P	P	P	P		4
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 5 I 0(k) of the transducer: Letter filed as a compatible transducer to Xario XG SSA-680A VI. I K072918

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC (Division Sign-Off) Note 9 3D Color (Volume Color) Division of Reproductive, Abdominal Note 10 STIC Color Note 11 Elastography

eproductive, Abdominal,
and Radiological Devices
510(k) Number K092948

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

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

System: Aplio MX v1.0 SSA-780A Transducer: PVT-375BT

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal	P	P	P	P	2	P	P	P			5, 7
Abdominal	P	P	P	P	2	P	P	P			5, 7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	2	P	P	P			5, 7
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure 1111 Note 7 Precision Imaging (Division Sign Off) Note 8 STIC Division of Reproductive, Abdominal, Note 9 3D Color (Volume Color) and Radiological Devices Note 10 STIC Color Note 11 Elastography 510(k) Number

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

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

System: Aplio MX v1.0 SSA-780A Transducer: PVT-375MV

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

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal	P	P	P		P	2	P	P	P		P	5,7,8,9,10
AbdomiPal	P	P	P		P	2	P	P	P		P	5,7,8,9,10
IPtra-operative (AbdomiPal)
IPtra-operative (Peuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	P	P		P	5,7,8,9,10
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging 120 Note 8 STIC (Division Sign-Off) Note 9 3D Color (Volume Color) Division of Reproductive, Abdomi Note 10 STIC Color and Radiological Devic Note 11 Elastography 510(k) Number.

Prescription Use Only (Per 21 CRF801.109)

B-8

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

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

Aplio MX v1.0 SSA-780A System: Transducer: PVT-382BT

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal	P	P	P		P	2	P	P	P			5
AbdomiPal	P	P	P		P	2	P	P	P			5
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	P	P			5
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC (Division Sign Off) Division of Reproductive, Abdominal Note 9 3D Color (Volume Color) Note 10 STIC Color and Radiological Devi

T.T.T

Note 11 Elastography

510(k) Number KD9274

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

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

System: Aplio MX v1.0 SSA-780A Transducer:_ PVT-382MV

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal	P	P	P		P	2	P	P	P		P	5,7
Abdominal	P	P	P		P	2	P	P	P		P	5,7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	P	P		P	5,7
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; DDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 TDI

Note 5 ApliPure Note 6 MicroPure

Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography

Hlen
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Device

510(k) Number K092948

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

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

System: Aplio MX v1.0 SSA-780A PVT-575MV Transducer:

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal	P	P	P		P	2	P	P	P		P	5,7,8
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro).
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/M/F; B/DF/MDF/PWD; 2D/CWD; BDF/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure u Note 6 MicroPure (Division Sign-Off) Note 7 Precision Imaging Division of Reproductive, Abdominal Note 8 STIC and Radiological Device Note 9 3D Color (Volume Color) Note 10 STIC Color 510(k) Number Note 11 Elastography

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

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

Aplio MX v1.0 SSA-780A System: __ Transducer:_ PVT-674BT

..............................................................................................................................................................................

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal	P	P	P		P	2	P	P	P			5
Abdominal	P	P	P		P	2	P	P	P			5
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	P	P			5
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer. K092179

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/MD; BDF/MDF; BDF/MD/F/PWD; 2D/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF

Note 4 TDI

Note 5 ApliPure

Note 6 MicroPure

Note 7 Precision Imaging

Note 8 STIC

Note 9 3D Color (Volume Color)

Note 10 STIC Color

Note 11 Elastography

Vklew

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device

510(k) Number

Prescription Use Only (Per 21 CRF801.109)

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

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

System: _ Aplio MX v1.0 SSA-780A Transducer:_ PVT-661 VT

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	P	2	N	P	P			4,5,11
Trans-vaginal	P	P	P	P	P	2	P	P	P			4,5
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/MDF; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging (Division Sign Off) Note 8 STIC Division of Reproductive, Abdominal, Note 9 3D Color (Volume Color) and Radiological Device Note 10 STIC Color Note 11 Elastography 510(k) Number

Prescription Use Only (Per 21 CRF801.109)

B-13

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

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

Aplio MX v1.0 SSA-780A System: Transducer: __ PVT-681MV

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (I)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	P	2	P	P	P	P	P	4,5,7,1
Trans-vaginal	P	P	P	P	P	2	P	P	P	P	P	4,5,7
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure (Division Sign Off) Note 7 Precision Imaging Division of Reproductive, Abdominal, Note 8 STIC and Radiological Device Note 9 3D Color (Volume Color) Note 10 STIC Color 510(k) Number . Note 11 Elastography Prescription Use Only (Per 21 CRF801.109)

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

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

System: Aplio MX v1.0 SSA-780A Transducer: PVT-745BTV

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

Clinical ApplicationSpecific(Tracks 3)	B	M	PWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	Other[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	2	P	P	P	5
Intra-operative (Abdominal)	P	P	P	P	2	P	P	P	5
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	2	P	P	P	5
Small Organ (Specify) (1)	P	P	P	P	2	P	P	P	5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD; BDF/CWD; Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging (Division Sign-Off) Note 8 STIC Division of Reproductive, Abdominal, Note 9 3D Color (Volume Color) and Radiological Device Note 10 STIC Color 510(k) Number. Note 11 Elastography Prescription Use Only (Per 21 CRF801.109)

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

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

System: Aplio MX v1.0 SSA-780A Transducer: __ PVT-770RT

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	P	2	P	P	P			5
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes BlM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/P WD
Note 3 Combined mode includes B/M; B/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging (Division Sign-Off) Note 8 STIC Division of Reproductive, Abdominal Note 9 3D Color (Volume Color) and Radiological Devic Note 10 STIC Color Note 11 Elastography 510(k) Number

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

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

System: Aplio MX v1.0 SSA-780A Transducer: PLT-604AT

: {

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

Clinical Application			Mode of Operation
Specific(Tracks 3)	B	M		PWD CWD	ColorDoppler	Combined(Specify)	THI	DynamicFlow	Power	CHI2D	4D	Other(Note)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	P	P		P	P	2	P	P	P			5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card)
Musculo-skeletal (Conventional)	P	P	P		P	2	P	P	P			5
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P	P			5
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P		P	2	P	P	P			5
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note I Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; B/DF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure (Division Sign-Off) Note 7 Precision Imaging Note 8 STIC Division of Reproductive, Abdominal. and Radiological Devices Note 9 3D Color (Volume Color) Note 10 STIC Color 510(k) Number Note 11 Elastography Prescription Use Only (Per 21 CRF801.109)

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

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

System: _ Aplio MX v1.0 SSA-780A Transducer: PLT-704AT

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

Clinical Application			Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	P	P	P		P	2	P	P	P			5
Neonatal Cephalic								P	P
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)	P	P	P		P	2	P	P	P			5
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P	P			5
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P		P	2	P	P	P			5
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PVD; BDF/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes Brin, BF WD, BDF/MDF, BDF/MDF/PWD
Note 4 TDI Note 4 TDI Note 5 ApliPure Note 6 MicroPure (Division Sign-Off Note 7 Precision Imaging Division of Reproductive, Abdominal Note 8 STIC and Radiological Dev Note 9 3D Color (Volume Color) Note 10 STIC Color 510(k) Number Note 11 Elastography

{21}------------------------------------------------

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

System: Aplio MX_v1.0 SSA-780A Transducer: PLT-704SBT

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	P	P	P		P	2	P	P	P			5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)	P	P	P		P	2	P	P	P			5
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P	P			5
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P		P	2	P	P	P			5
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; BPWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; DD/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/

Note 4 TDI
Note 5 ApliPure

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devi

510(k) Number

{22}------------------------------------------------

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

Aplio MX v1.0 SSA-780A System: Transducer: PLT-705BTH

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P	P			5
Intra-operative (Abdominal)	P	P	P		P	2	P	P	P			5
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	P	P			5
Small Organ (Specify) (1)	P	P	P		P	2	P	P	P			5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note I Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC (Division Sign-Off) Note 9 3D Color (Volume Color) Division of Reproductive, Abdominal, Note 10 STIC Color and Radiological Devi Note 11 Elastography

Prescription Use Only (Per 21 CRF801.109)

B-20

510(k) Number

{23}------------------------------------------------

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

System: Aplio MX v1.0 SSA-780A Transducer: PLT-705BTF

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P	P			5
Intra-operative (Abdominal)	P	P	P		P	2	P	P	P			5
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	P	P			5
Small Organ (Specify) (1)	P	P	P		P	2	P	P	P			5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF; BDF/M/B/PWD Note 3 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF; PVD; 2D/CWD; BDF/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure ulu Note 6 MicroPure (Division Sign-Off) Note 7 Precision Imaging Division of Reproductive, Abdominal, Note 8 STIC and Radiological Device Note 9 3D Color (Volume Color) Note 10 STIC Color 510(k) Number Note 11 Elastography Prescription Use Only (Per 21 CRF801.109)

{24}------------------------------------------------

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

Aplio MX v1.0 SSA-780A System: Transducer: __ PLT-80SAT

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	P	P	P		P	2	P	P	P			5,6,7,11
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	P	P	P		P	2	P	P	P			5,6,7,11
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P	P			5,6,7,11
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P		P	2	P	P	P			5,6,7,11
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes BM; BPWD; BDF/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes Brity Br. WD, BDFMDF, BDFMDF, BDFMDFFPWD, 2D/CWD; BDF/CWD
Note 4 TDI Note 4 TDI Note 5 ApliPure Note 6 MicroPure 1 the Note 7 Precision Imaging (Division Sign-Off) Note 8 STIC Division of Reproductive, Abdominal. Note 9 3D Color (Volume Color) and Radiological Devic Note 10 STIC Color Note 11 Elastography S10(k) Number Prescription Use Only (Per 21 CRF801.109)

{25}------------------------------------------------

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

Aplio MX v1.0 SSA-780A System: _ PLT-1202S Transducer:

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

Clinical ApplicationSpecific(Tracks 3)	B	M	PWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)	P	P	P	P	2	P	P	P	4,5,11
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	P	P	P	P	2	P	P	P	4,5,11
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	P	P	P	P		P	P	P	4,5,11
Musculo-skeletal (Superficial)	P	P	P	P	2	P	P	P	4,5,11
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P	P	2	P	P	P	4,5,11
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note I Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC (Division Sign-Off) Note 9 3D Color (Volume Color) Division of Reproductive, Abdominal, Note 10 STIC Color and Radiological Devices Note 11 Elastography

510(k) Number_

Prescription Use Only (Per 21 CRF801.109)

1. 1. 1. 1. 11

{26}------------------------------------------------

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

System: __ Aplio MX v1.0 SSA-780A Transducer: PLT-1204AT

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	P	P	P		P	2	P	P	P				4,5,6,7,
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)	P	P	P		P	2	P	P	P				4,5,6,7,
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P	P				4,5,6,7,
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P		P	2	P	P	P				4,5,6,7,
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note I Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BQF/M/DF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Um Note 6 MicroPure (Division Sign-Off) Note 7 Precision Imaging Division of Reproductive, Abdominal, Note 8 STIC Note 9 3D Color (Volume Color) and Radiological Devic Note 10 STIC Color 510(k) Number Note 11 Elastography

{27}------------------------------------------------

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

System: ______________________________________________________________________________________________________________________________________________________________________ Transducer: PLT-1204BT

ー

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	P	P	P		P	2	P	P	P			4,5,6,1
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)	P	P	P		P	2	P	P	P			4,5,6,1
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P	P			4,5,6,1
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac.
Other (Specify)
Peripheral vessel	P	P	P		P	2	P	P	P			4,5,6,1
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes BM; B/PWD; BDF/MD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Ul un Note 7 Precision Imaging (Division Sign-Off) Note 8 STIC Division of Reproductive, Abdominal, Note 9 3D Color (Volume Color) and Radiological Devic Note 10 STIC Color Note 11 Elastography

510(k) Number_

Prescription Use Only (Per 21 CRF801.109)

... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

{28}------------------------------------------------

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

Aplio MX v1.0 SSA-780A System: __ Transducer: PLT-1204MV

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	Dynamic Flow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	P	P	P		P	2	P	P	P		P	5,7,9
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)	P	P	P		P	2	P	P	P		P	5,7,9
Musculo-skeletal (Superficial)	P	p	P		P	2	P	P	P		P	5,7,9
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P		P	2	P	P	P		P	5,7,9
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note I Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging (Division Sign-Off) Note 8 STIC Division of Reproductive, Abdominal, Note 9 3D Color (Volume Color) and Radiological Devices Note 10 STIC Color Note 11 Elastography 510(k) Number.

10(K) Number

{29}------------------------------------------------

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

Aplio MX v1.0 SSA-780A System: Transducer: PET-510MB

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

Clinical Application			Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)	P	P	P	P	P	3	P					4
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note I Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging (Division Sign-Off) Note 8 STIC Division of Reproductive, Abdominal, Note 9 3D Color (Volume Color) and Radiological Devi Note 10 STIC Color 510(k) Number Note 11 Elastography

{30}------------------------------------------------

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

System: Aplio MX v1.0 SSA-780A Transducer: PET-508MA

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)	P	P	P	P	P	3	P					4
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: Letter filed as a compatible transducer to Xario XG SSA-680A VI.I. K072918

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/MD; BDF/MDF; BDF/MDF; PWD; 2D/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure (Division Sien Off) Note 7 Precision Imaging Division of Reproductive, Abdominal, Note 8 STIC and Radiological Devic Note 9 3D Color (Volume Color) 510(k) Number Note 10 STIC Color Note 11 Elastography

{31}------------------------------------------------

510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

System: ______________________________________________________________________________________________________________________________________________________________________ Aplio MX v1.0 SSA-780A Transducer: PC-20M

i: 1

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult				P
Cardiac Pediatric				P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel				P
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/MD; BDF/MD; BDF/MDF/PWD; 2D/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/C Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging (Division Sign-Off) Note 8 STIC Division of Reproductive, Abdominal, Note 9 3D Color (Volume Color) and Radiological Devic Note 10 STIC Color 510(k) Number Note 11 Elastography

{32}------------------------------------------------

510{k} Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System

System: Aplio MX v1.0 SSA-780A Transducer: PC-50M

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult			P
Cardiac Pediatric			P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel			P
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179

Note I Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/ BDF/MDF/FWD; 2D/CWD; BDF/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging (Division Sign-Off) Note 8 STIC Division of Reproductive, Abdominal Note 9 3D Color (Volume Color) and Radiological Devic Note 10 STIC Color Note 11 Elastography 510(k) Number

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.