Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.

Therapeutic

No
The device description and intended use indicate it is an ultrasound diagnostic system used for imaging and determining the relative elasticity of lesions, not for providing therapy.

Diagnostic

Yes
The device is described as an "Ultrasound Diagnostic System" for various anatomical studies, and elastography is indicated for "determining the relative elasticity of a lesion," which are all diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "mobile system" and employs "a wide array of probes," indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use describes the device as being used for various imaging studies of different anatomical sites and patient types. This is characteristic of an in vivo diagnostic device (used within a living organism), not an in vitro diagnostic device (used on samples taken from the body).
Device Description: The description mentions a "mobile system" that employs "probes" and operates within a specific "frequency range." This is consistent with an ultrasound system, which is an imaging modality used directly on the patient.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.

Therefore, the Aplio v4.0R001 is an ultrasound diagnostic system used for imaging, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Aplio v4.0R001 is intended to be used for the following type of studies: fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectail, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).
Elastography is indicated for determining the relative elasticity of a lesion.
Diagnostic ultrasound imaging or fluid flow analysis of the human body for various clinical applications (Ophthalmic, Fetal, Abdominal, Intra-operative (Abdominal/Neuro), Laparoscopic, Pediatric, Small Organ (Thyroid, breast and testicle), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esophageal (non-Cardiac/Cardiac), Musculo-skeletal (Conventional/Superficial), Intravascular (Cardiac), Intra-cardiac, Peripheral vessel) using various modes of operation including B, M, PWD, CWD, Color Doppler, Combined (B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD), THI, Dynamic Flow, Power, CHI 2D, 3D, 4D, and other notes such as TDI, ApliPure, MicroPure, Precision Imaging, STIC, 3D color, STIC Color, and Elastography (New).

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

90-IYN, 90-IYO, 90-ITX, TYN

Device Description

The Aplio XG v4.0R001 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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

fetal, abdominal, intraoperative, pediatric, small organs (thyroid, breast, testicle), neonatal cephalic, adult cephalic, cardiac, transrectail, transvaginal, transesophageal, peripheral vascular, musculo-skeletal

Indicated Patient Age Range

Not Found

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

K091295, K090334

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

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

10092179

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

510(k) Summary

JUL 2 9 2009 Submitter's Name: Toshiba America Medical Systems, Inc. Address: PO Box 2068, 2441 Michelle Drive Tustin, CA 92781-2068 Contact: Paul Biggins, Director Regulatory Affairs Telephone No .: (714) 730-5000

Device Proprietary Name: Common Name: .

APLIO XG MODEL SSA-790A Version 4.0R001 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 t [Fed. Reg. No.: 892.1570]

Identification of Predicate Devices:

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

Toshiba Ultrasound Diagnostic System Aplio XG MODEL SSA-790A V4.0 510(k) K091295 .
Siemens Medical Solutions Acuson S2000 Diagnostic Ultrasound System 510(k) K090334 .

Device Description:

The Aplio XG v4.0R001 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

Intended Use:

The Aplio v4.0R001 is intended to be used for the following type of studies: fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectail, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).

Safety Considerations:

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

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), IEC 60601-2-37 (applicable portions), IEC 62304 (applicable porton) and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard a

Standards Forms:

The standards forms are the same as those submitted for the Aplio XG v4.0 K091295.

Clinical Trials Form

Please see the attached Clinical Trials Form FDA-3674

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with outstretched wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUL 2 9 2009

Re: K092179

Trade/Device Name: Elastography for SSA-790A Aplio XG v4.0R001 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasound pulsed doppler imaging system Regulatory Class: II Product Code: TYN, IYO, and ITX Dated: July 17, 2009 Received: July 21, 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 Elastography for SSA-790A Aplio XG v4.0R001 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

PLT-604AT PLT-704AT PLT-704SBT PLT-705BTH PLT-705BTF PLT-805AT PLT-1202S PLT-1204AT

PLT-1204BT PLT-1204AX PLT-1204BX PLT-1204MV PET-510MB PC-20M PC-50M PST-25BT

3

PST-30BT	PVT-575MV
PST-50AT	PVT-674BT
PST-65AT	PVT-661VT
PVT-375BT	PVT-681MV
PVT-375MV	PVT-745BTV
PET-382BT	PVT-770RT
PVT-382MV

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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Sunder Rajan at (240) 276-3666.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

4

510(k) Number (if known):

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ültrasound System

Ko92179

Device Name: Elastography for SSA-790A Aplio XG v4.0R001 Diagnostic Ultrasound System

Indications for Use:

Elastography is indicated for determining the relative elasticity of a lesion.

Prescription Use Only (Per 21 CRF801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal,

and Radiological Devices 510(k) Number.

5

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: _ Aplio XG v4.0R001 SSA-790A 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	Color
Doppler	Combined
(Specify)	THI	Dynamic
Flow	Power	CHI
2D	4D	Other
[Note]
Ophthalmic
Fetal	P	P	P	P	P	2	P	P	P	P	P	5,7,8,9,10
Abdominal	P	P	P	P	P	2,3	P	P	P	P	P	5,7,8,9,10
Intra-operative (Abdominal)	P	P	P	P	P	2	P	P	P			4,5
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	2,3	P	P	P	P	P	5,7,8,9,10
Small Organ (Note 1)	P	P	P	P	P	2	P	P	P			4,5,6,7,9,1
Neonatal Cephalic	P	P	P	P	P	3	P	P	P	P
Adult Cephalic	P	P	P	P	P	3	P	P	P	P
Trans-rectal	P	P	P	P	P	2	P	P	P	P	P	4,5,7,11
Trans-vaginal	P	P	P		P	2	P	P	P	P	P	4,5,7
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)	P	P	P		P	2	P	P	P	P		4,5,6,7,9,1
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P	P			4,5,6,7,9,1
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)	P	P	P	P	P	3	P					4
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P	P	P	2	P	P	P	P		4,5,6,7,9,1
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K091295

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 Birl, BDTMDF, BDFMDFF, BDF/MDF/P WD
Note 3 Combined mode includes B/M; B/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; Note 4 TDI

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

Note 5 ApliPure

Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D color

Note 10 STIC Color

Note 11 Elastography (New)

vision Sign-Off Division of Reproductive, Abdominal, and Radiological De 510(k) Number

6

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: Aplio XG v4.0R001 SSA-790A Transducer: PLT-604AT

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

| Clinical Application
Specific
(Tracks 3) | Mode of Operation
B | M | PWD | CWD | Color
Doppler | Combined
(Specify)* | THI | Dynamic
Flow | Power | CHI
2D | 3D | 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 |
| 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 |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | 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 | P | | 5 |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous SIO(k) of the transducer: K091295

Note { 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; BPWD; 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/C Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D color Note 10 STIC Color Note 11 Elastography (New)

Prescription Use Only (Per 21 CRF801 109)

signature

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number

7

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: Aplio XG v4.0R001 SSA-790A 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	Color Doppler	Combined (Specify)	THI	Dynamic Flow	Power 2D	CHI 3D	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
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
Musculo-skeletal (Superficial)	P	P	P	P	2	P	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	P	5
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K091295

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; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D color Note 10 STIC Color Note 11 Elastography (New)

Prescription Use Only (Per 2) CRF801.109)

Hee Rem

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

510(k) Number

8

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: Aplio XG v4.0R001 SSA-790A 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	Color
Doppler	Combined
(Specify)*	THI	Dynamic
Flow	Power	CHI
2D	3D	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
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
Musculo-skeletal (Superficial)	P	P	P		P	2	P	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	P	5
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K091295

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, BPWD; WD; BDF/MDF; BDF/MDFf/PWD; 2D/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D color Note 10 STIC Color . (Division Sign-Off) Note 11 Elastography (New)

Division of Reproductive, Abdominal, and Radiological De 510(k) Number

9

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: _ Aplio XG v4.0R001 SSA-790A 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	Color
Doppler	Combined
(Specify)	THI	Dynamic
Flow	Power	CHI
2D	3D	Other
[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P	P	P	5
Intra-operative (Abdominal)	P	P	P		P	2	P	P	P	P	5
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	P	P	P	5
Small Organ (Specify) (1)	P	P	P		P	2	P	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: K091295

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; 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 Note 10 STIC Color Note 11 Elastography (New)

Prescription Use Only (Per 21 CRF801.109)

Heflen

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

510(k) Number

10

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: ______________________________________________________________________________________________________________________________________________________________________ Aplio XG v4.0R001 SSA-790A 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	Color
Doppler	Combined
(Specify)*	THI	Dynamic
Flow	Power	CHI
2D	3D	Other
[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	2	P	P	P	P	5
Intra-operative (Abdominal)	P	P	P	P	2	P	P	P	P	5
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	2	P	P	P	P	5
Small Organ (Specify) (1)	P	P	P	P	2	P	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: K091295

. .

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 Note 10 STIC Color Note 11 Elastography (New)

Prescription Use Only (Per 21 CRF801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number

11

510(k) Premarket Notification Aplio™ XG (v4.0R00!) SSA-790A Ultrasound System

System: Aplio XG v4.0R001 SSA-790A Transducer:_ PLT-805AT -----

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

| Clinical Application (Note) | |
|---------------------------- | Specific
(Tracks 3) | B Doppler | Combined
(Specify) | THI | Dynamic
Flow | Power | CHI
2D | | 3D |
| 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) | P | Musculo-skeletal (Superficial) | Intravascular | Other (Specify) | Cardiac Adult | Cardiac Pediatric | Intravascular (Cardiac) | Trans-esoph. (Cardiac) | Intra-cardiac | Other (Specify) | Peripheral vessel | Other (Specify) | Mode of Operation | | | | | | | | | Other
--------|-------------------|---|---------|------------------|-----------------------|-----|-----------------|-------|-----------|-----------------|-------|
| M | PWD CWD | Color
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| P | P | P | P | 2 | P | P | P | P | | 5,6,7 |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| P | P | P | 2 | P | P | P | P | | 5,6,7 |
| P | P | P | P | 2 | P | P | P | P | | 5,6,7 |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| P | P | P | P | 2 | P | P | P | P | | 5,6,7 |
| | | | | | | | | | | |

.. ... ...

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K091295

….

i

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; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D color Note 10 STIC Color Note II Elastography (New)

. .

Hui Rem
(Division Sign-Off)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K092179

12

.

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: _ Aplio XG v4.0R001 SSA-790A Transducer:____PLT-1202S

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	Color
Doppler	Combined*
(Specify)	THI	Dynamic
Flow	Power	CHI
2D	3D	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	2	P	P	P	4,5,1
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	4,5,1
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K091295

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 Note & STIC Note 9 3D color Note 10 STIC Color Note 11 Elastography (New)

Prescription Use Only (Per 21 CRF801.109)

·

Hut Rumen

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

51.0(k) Number.

13

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: _ Aplio XG v4.0R00I SSA-790A PLT-1204AT____ 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	Color
Doppler	Combined
(Specify)	THI	Dynamic
Flow	Power	CHI
2D	3D	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: K091295

.. . ...

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

. .

.......

Prescription Use Only (Per 21 CRF801.109)

Dision Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number

14

System: Aplio XG v4.0R001 SSA-790A Transducer: _ PLT-1204BT

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	Color
Doppler	Combined
(Specify)

| THI | Dynamic
Flow | Power | CHI
2D | 3D | 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, |
| Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K091295

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 Note 9 3D color Note 10 STIC Color Note 11 Elastography (New)

Prescription Use Only (Per 21 CRF801.109)

Hellem

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number.

) 10(k). Numbe

15

510(k) Premarket Notification

Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

Aplio XG v4.0R001 SSA-790A System: Transducer: PLT-1204AX____________________________________________________________________________________________________________________________________________________________________

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

| Clinical Application | Mode of Operation | | | | | | | Other
[Note] | | | | |
|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|-------|-----------------|-----------------|-------|-----------|---------|
| Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | THI * | | Dynamic
Flow | Power | CHI
2D | 3D |
| 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 SIO(k) of the transducer: K091295

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/MDF; BDF/MDF; BDF/MDF/PWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D color Note 10 STIC Color Note 11 Elastography (New)

Prescription Use Only (Per 21 CRF801.109)

H.D. Loum

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

16

510(k) Premarket Notification

Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: Aplio XG v4.0R001 SSA-790A Transducer: PLT-1204BX

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

......

| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | THI | Dynamic
Flow | Power | CHI
2D | 3D | 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 | | | | 4,5,6,7,1 |
| 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 | | | | 4,5,6,7,1 |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | | | | 4,5,6,7,1 |
| 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 | | | | 4,5,6,7,1 |
| Other (Specify) | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K091295

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/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/CWD; BDF Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D color Note 10 STIC Color Note 11 Elastography (New)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K092.179

17

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: ______________________________________________________________________________________________________________________________________________________________________ Aplio XG v4.0R001 SSA-790A 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	Color
Doppler	Combined
(Specify)*	THI	Dynamic
Flow	Power	CHI
2D	3D	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 5 10(k) of the transducer: K09 | 295

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/MDF/PWD Note - Journed mode melades Briti, Bri WD, BDF/PWD; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDJ Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D color Note 10 STIC Color Note 11 Elastography (New)

Prescription Use Only (Per 21 CRF801.109)

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

510(k) Number.

ices
K9217

18

.

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: _ Aplio XG v4.0R001 SSA-790A Transducer:_ PET-510MB

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

| Clinical Application
Specific
(Tracks 3) | B | M | PWD CWD | Color
Doppler | Combined
(Specify) | THI | Dynamic
Flow | Power
CHI
2D | 3D | 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 | 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: K091295

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 Note 10 STIC Color Note 11 Elastography (New)

Prescription Use Only (Per 21 CRF801.109)

Hublene

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

19

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

Aplio XG v4.0R001 SSA-790A System: Transducer: PC-20M

. Formed over. (FC 29(V))

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	Color
Doppler	Combined
(Specify)

| THI | Dynamic
Flow | Power | CHI
2D | 3D | 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 | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K091295

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes BIM; B/PWD; BDF/MD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes BIM; BIPWD; BDF/MDF; BDF/MDF/PWD; DD/CWD; BDF/CWD; BDF/CWD;
Narci & TD) Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D color Note 10 STIC Color (Division Sign-Off) Note I I Elastography (New)

Prescription Use Only (Per 21 CRF801.109)

. .

Hulten

Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number.

20

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

Aplio XG v4.0R00I SSA-790A System: _ 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	Color
Doppler	Combined
(Specify) *	THI	Dynamic
Flow	Power	CHI
2D	3D	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: K091295

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/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/CWD; BDF Note 4 TDI Note S ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D color Note 10 STIC Color Note 11 Elastography (New)

Jutken

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

21

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

Aplio XG v4.0R001 SSA-790A System: Fransducer: 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	Color
Doppler	Combined
(Specify)	THI	Dynamic
Flow	Power	CHI
2D	4D	Other
[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	3	P	P	P	P
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	3	P	P	P	P
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	P	3	P	P	P	P
Adult Cephalic	P	P	P	P	P	3	P	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: K091295

Note 1 Small organ includes thyroid, breast and testicle.

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

Note 3 Combined mode includes Bin, Br. WD, BDF/NDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BD

Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D color Note 10 STIC Color Note 11 Elastography (New)
Hublenn

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

22

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: _ Aplio XG v4.0R001 SSA-790A Transducer:_ PST-30BT

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

| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify)

| THI | Dynamic
Flow | Power | CHI
2D | 3D | Other
[Note] |
|------------------------------------------------|---|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|-----------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | P | P | P | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | P | P | P | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | P | | |
| Adult Cephalic | P | P | P | P | P | 3 | P | 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: K091295

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 Note 10 STIC Color Note 11 Elastography (New) .

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number

23

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: ____________________________________________________________________________________________________________________________________________________________________ Transducer: PST-50AT

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

Clinical Application Specific (Tracks 3)	Mode of Operation
	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	THI	Dynamic Flow	Power	CHI 2D	3D	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: K091295

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 mode includes BrM, BiP WD; BDFMDFfPWD
Note 3 Combined mode includes B/M; BiPWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 BD color Note 10 STIC Color Note I | Elastography (New)

Prescription Use Only (Per 21 CRF801.109)

Veet Remm

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

510(k) Number

24

510(k) Premarket Notification

Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: __ Aplio XG v4.0R001 SSA-790A Transducer: PST-65AT

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

| Clinical Application
Specific
(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) * | THI | Dynamic
Flow | Power | CHI
2D | 3D | 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 |
| 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: K091295

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 Brity, BR WD, DDFMDF, BDFMDFF WD
Note 3 Combined mode includes BIM; BIPWD; 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 Note 9 3D color Note 10 STIC Color Note 11 Elastography (New)

Prescription Use Only (Per 21 CRF801.109)

. |

H
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

25

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: Aplio XG v4.0R001 SSA-790A Transducer: PVT-375BT

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

| Clinical Application | Mode of Operation | | | | | | | | | Other
[Note] | | |
|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|-----|-----------------|-------|-----------------|-----------|-----|
| Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | THI | Dynamic
Flow | Power | | CHI
2D | 3D |
| 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: K091295

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 Briv, Br WD, BDF/PWD, BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BD

Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging
Note 8 STIC Note 9 3D color Note 1.0 STIC Color Note 11 Elastography (New)

Harlem

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number.

26

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

Aplio XG v4.0R001 SSA-790A System: _ Transducer:____ PVT-375MV

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	Color
Doppler	Combined
(Specify)

| THI | Dynamic
Flow | Power | CHI
2D | 3D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | P | P | 5,7,8,9,10 |
| Abdominal | P | P | P | | P | 2 | P | P | P | P | P | 5,7,8,9,10 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | P | P | 5,7,8,9,10 |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethrai | | | | | | | | | | | | |
| 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: K091295

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 Commer mode includes BM, BP WD, BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CW Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D color Note 10 STIC Color Note 11 Elastography (New)

Prescription Use Only (Per 21 CRF801.109)

Hutabum

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

27

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: Aplio XG v4.0R001 SSA-790A Transducer:_ PET-382BT

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

| Clinical Application
Specific

(Tracks 3)	Mode of Operation
	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	THI	Dynamic
Flow	Power	CHI
2D	3D	Other
[Note]
Ophthalmic
Fetal	P	P	P		P	2	P	P	P	P	5
Abdominal	P	P	P		P	2	P	P	P	P	5
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	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: K091295

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/MDF/PWD Note 3 Commed mode includes BM, BR WD, BDFP WD, BDFMDFFPWD
Note 3 Comined mode includes B/M; B/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D color Note 10 STIC Color Note 11 Elastography (New)

Prescription Use Only (Per 21 CRF801.109)

Hew Rem

(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number _

28

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: _ Aplio XG v4.0R001 SSA-790A Transducer: PVT-382MV

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

| Clinical Application | Mode of Operation | | | | | | | | | | Other
[Note] |
|------------------------------------|-------------------|---|---------|------------------|-----------------------|-----|-----------------|-------|-----------|----|-----------------|
| Specific
(Tracks 3) | B | M | PWD CWD | Color
Doppler | Combined
(Specify) | THI | Dynamic
Flow | Power | CHI
2D | 3D | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | P | 2 | P | P | P | P | P | 5,7 |
| Abdominal | P | P | P | P | 2 | P | P | P | P | P | 5,7 |
| Intra-operative (Abdominal) | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | P | P | P | P | 2 | P | 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: K091295

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/MDF/PWD Note 3 Combined mode includes BM, BR WD, BDFMDF, BDFMDFF, BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 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 Note 10 STIC Color Note 11 Elastography (New)

Prescription Use Only (Per 21 CRF801.109)

Hw Lewn

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

510(k) Number.

29

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

Aplio XG v4.0R001 SSA-790A System: _ Transducer:_ PVT-275MV

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

Clinical Application			Mode of Operation
Specific
(Tracks 3)	B	M	PWD CWD	Color
Doppler	Combined
(Specify)	THI	Dynamic
Flow	Power	CHI
2D	3D	Other
[Note]
Ophthalmic
Fetal	P	P	P	P	2	P	P	P	P	P	5,7,8
Abdominal				P
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: K091295

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/MDF/PWD Note 3 Combined mode model Brit, Br WD, BDF/PWD; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/C Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D color Note IO STIC Color Note I I Elastography (New)

Prescription Use Only (Per 21 CRF801.109)

Hal Rem

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

$10(k) Number

......

30

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: ____________________________________________________________________________________________________________________________________________________________________ Aplio XG v4.0R001 SSA-790A Transducer: PVT-674BT

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

| Clinical Application
Specific

(Tracks 3)	Mode of Operation
	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)

| THI | Dynamic
Flow | Power | CHI
2D | 3D | Other
Note |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | P | | 5 |
| Abdominal | P | P | P | | P | 2 | P | P | P | P | | 5 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | 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: K091295

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 Brity Br WD, BDFM WD, BDFMDFfPWD, BDFlMDFlPWD, BDFlCWD
Note 4 TD1 Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D color Note 10 STIC Color A Note 11 Elastography (New)

Prescription Use Only (Per 21 CRF801 109)

.

Hw Lemm

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number .

31

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: _ Aplio XG v4.0R001 SSA-790A PVT-66I VT Transducer:

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

| Clinical Application
Specific
(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | THI | Dynamic
Flow | Power | CHI
2D | 3D | 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 | 2 | P | P | P | P | | 4,5,11 |
| Trans-vaginal | | P | P | P | | P | 2 | P | 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: K091295

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/P WD; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D color Note 10 STIC Color Note 11 Elastography (New)

Prescription Use Only (Per 21 CRF801.109)

Hertlan

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

510(k) Number

K092129

32

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: __ Aplio XG v4.0R001 SSA-790A 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	Color
Doppler	Combined*
(Specify)	THI	Dynamic
Flow	Power	CHI
2D	3D	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	2	P	P	P	P	P	4,5,7,1
Trans-vaginal	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: K091295

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 Note 9 3D color Note 10 STIC Color Note 11 Elastography (New) (Division Sign-Off) Prescription Use Only (Per 21 CRF801-109)

Haleem

Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number.

33

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

Aplio XG v4.0R001 SSA-790A System: Transducer: PVT-745BTV

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

Clinical Application Mode of Operation Specific PWD CWD B M Color Combined THI Dynamic Power CHI 3D Other (Tracks 3) Doppler | (Specify) Flow 2D [Note} Ophthalmic Fetal Abdominal P P Intra-operative (Abdominal) p P P Intra-operative (Neuro) Laparoscopic Pediatric P Small Organ (Specify) (1) ല P Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-wethral Trans-esoph. (non-Card.) Musculo-skeletal (Conventional) Musculo-skeleta! (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: K091295

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 mel Melized Brit, Sr WD, BDF/F WD, BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/MDF/PWD; 2D/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 Note 10 STIC Color Note 11 Elastography (New)

Prescription Use Only (Per 21 CRF801.109)

Hes Rem

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

510(k) Number _

K092/29

34

510(k) Premarket Notification

Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: _ Aplio XG v4.0R001 SSA-790A Transducer: PVT-770RT

lntended 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	Color
Doppler	Combined
(Specify)	THI	Dynamic
Flow	Power
CHI
2D	3D	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	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: K091295

Note I Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes BIM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes Brit, BA WD, BDFMDF; BDFMDF/PWD
Note 3 Combined mode includes BIM; B/PWD; BDF/MDF; BDF/MDF/PWD; 2D/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 Note 10 STIC Color Note 11 Elastography (New)

. . ..

. ... ...

Prescription Use Only (Per 21 CRF801 109)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

Intended Use / Indications for Use

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

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

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

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

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

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

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

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

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

§ 892.1550 Ultrasonic pulsed doppler imaging system.

510(k) Summary

Classification:

Identification of Predicate Devices:

Device Description:

Intended Use:

Safety Considerations:

Declaration of Conformity:

Standards Forms:

Clinical Trials Form

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: _ Aplio XG v4.0R001 SSA-790A Transducer: __________________________________________________________________________________________________________________________________________________________________

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: Aplio XG v4.0R001 SSA-790A Transducer: PLT-604AT

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: _ Aplio XG v4.0R001 SSA-790A Transducer: PLT-705BTH

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

510(k) Premarket Notification Aplio™ XG (v4.0R00!) SSA-790A Ultrasound System

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: _ Aplio XG v4.0R00I SSA-790A PLT-1204AT____ Transducer:

System: Aplio XG v4.0R001 SSA-790A Transducer: _ PLT-1204BT

510(k) Premarket Notification

510(k) Premarket Notification

System: Aplio XG v4.0R001 SSA-790A Transducer: PLT-1204BX

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: ______________________________________________________________________________________________________________________________________________________________________ Aplio XG v4.0R001 SSA-790A Transducer:_ PLT-1204MV

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: _ Aplio XG v4.0R001 SSA-790A Transducer:_ PET-510MB

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

Aplio XG v4.0R001 SSA-790A System: Transducer: PC-20M

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

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

Aplio XG v4.0R001 SSA-790A System: Fransducer: PST-25BT

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: ______________________________________________________________________________________________________________________________________________________________________ Transducer: __ PST-50AT

510(k) Premarket Notification

System: __ Aplio XG v4.0R001 SSA-790A Transducer: PST-65AT

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: Aplio XG v4.0R001 SSA-790A Transducer: PVT-375BT

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

Aplio XG v4.0R001 SSA-790A System: _ Transducer:____ PVT-375MV

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

Aplio XG v4.0R001 SSA-790A System: _ Transducer:_ PVT-275MV

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: ______________________________________________________________________________________________________________________________________________________________________ Aplio XG v4.0R001 SSA-790A Transducer: __ PVT-674BT

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: _ Aplio XG v4.0R001 SSA-790A PVT-66I VT Transducer:

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

Aplio XG v4.0R001 SSA-790A System: Transducer: PVT-745BTV

510(k) Premarket Notification

System: ____________________________________________________________________________________________________________________________________________________________________ Transducer: PST-50AT

System: ____________________________________________________________________________________________________________________________________________________________________ Aplio XG v4.0R001 SSA-790A Transducer: PVT-674BT