Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, deep learning, or any related terms, nor does it describe training or test sets typically associated with AI/ML development.

Therapeutic

No
The 'Intended Use / Indications for Use' section clearly states its purpose is "Diagnostic ultrasound imaging or fluid flow analysis," not therapeutic treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body".

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "mobile system" and "employs a wide array of probes," which are hardware components.

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 clearly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". This describes a device that uses physical principles (ultrasound waves) to create images or analyze flow within the body.
IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside of the body (in vitro).
Device Description: The description details a "mobile system" that uses "probes" to interact with the body. This is consistent with an in-vivo imaging device, not an in-vitro diagnostic test.
Anatomical Site: The listed anatomical sites are all locations within the human body where ultrasound imaging is performed.

Therefore, the Aplio XG v4.0 is an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intra-operative (Abdominal), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (Note 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).

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

Product codes

90-I YN, 90-IYO, 90-ITX, TYN, IYO, ITX

Device Description

The Aplio XG v4.0 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

Not Found

Anatomical Site

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

Indicated Patient Age Range

Pediatric, Adult, Neonatal

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)

Toshiba Ultrasound Diagnostic System Aplio XG MODEL SSA-790A V3.0 510(k) K082119

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.

Summary

0

K091295

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

510(k) Summary

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

APLIO XG MODEL SSA-790A Version 4.0 Device Proprietary Name: Common Name: Diagnostic Ultrasound System

Classification:

Regulatory Class: II ಂ
o Review Category: Tier II
Ultrasonic Pulsed Doppler Imaging System Product Code: 90-I YN o [Fed. Reg.No .: 892.1550]
Ultrasonic Pulsed Echo Imaging System Product Code: 90-IYO o [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 Ultrasound Diagnostic System Aplio XG MODEL SSA-790A V3.0 510(k) K082119 ם

Device Description:

The Aplio XG v4.0 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.

lintendled Use:

The Aplio v4.0 is intended to be used for the following type of studies: fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, cardiac, cardiac, transrectal, 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.

MAY 11 5 2009

1

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

MAY 15 2009

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

Re: K091295

Trade/Device Name: APLIO XG Diagnostic Ultrasound System, Model SSA-790A version 4.0 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: TYN, IYO, and ITX Dated: May 1, 2009 Received: May 4, 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 XG Diagnostic Ultrasound System, Model SSA-790A version 4.0, as described in your premarket notification :.

Transducer Model Number

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

2

Page 2 - Mr. Job

Enclosure(s)

PLT-704AT	PLT-1202S	PLT-1204MV
PLT-704SBT	PLT-1204AT	PET-510MB
PLT-705BTH	PLT-1204BT	PC-20M
PLT-705BTF	PLT-1204AX	PC-50M
PLT-805AT	PLT-1204BX

If vour 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 Ictter 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 Paul Hardy at (240) 276-3666.

Sincerely yours,

hoquethihang

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

3

System: _Aplio XG v4.0 SSA-790A Transducer: __________________________________________________________________________________________________________________________________________________________________

ﻟﻤﺴﺎﺑ

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	Combined THI Dynamic Power
Doppler . (Specify)		Flow		CHI
2D	4 D	Other
INotel
Ophthalmic
Fetal						2					:5.7.8.9.10
Abdominal						23					5,7,8,9,10
Intra-operative (Abdominal)						2					4,5
ilntra-operative (Neuro)
Laparoscopic
Pediatric						23					5,7,8,9,10;
Small Organ (Note I)											4.5,6,7,9
Neonatal Cephalic								P		p
Adult Cephalic
Trans-rectal											4.5.7
Trans-vaginal					P						4.5.7
Trans-urethral
Trans-esoph, (non-Card.)
Musculo-skeletal
(Conventional)	p	P			p	7			P		4,5,6,7,9
Musculo-skeletal (Superficial)	P	p	P						P	C	4-5.6.7.9
Intravascular
Other (Specify)
Cardiac Adult										D
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)					p	3
Intra-cardiac
Other (Specify)
!Peripheral vessel
		P P		P	P	2	P	p	P	P	4,5.6,7.9
Other (Specify)

N = new indication: P = previously cleared by FDA: E = added under this appendix Previous 510(k) of the transducer: K082119

Note 1 Small organ includes thyrnid, 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 (New) (Division Sign=Off) Note 8 STIC Division of Reproductive, Abdominal and Note 9 3D color (New)

Note 10 STIC Color (New)

Radiolog 510(k) Nu

4

System: __ Aplio XG v4.0 SSA-790A Transducer:__ PST-25BT

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

Clinical Application	Mode of Operation									Other
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler
(Specify)	Combined	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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K082119

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 (New) Note 8 STIC

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

Hogue In Whang

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

5

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

Aplio XG v4.0 SSA-790A System: Transducer:___PST-30BT

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	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: K082119

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

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

Prescription Use Only (Per 21 CRF801.109)

B-3

6

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

ું છ

Aplio XG v4.0 SSA-790A System: Transducer:__PST-50AT

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

| Clinical Application Note |
|------------------------------- | Specific
(Tracks 3) | B Doppler | Combined
(Specify) | THI | Dynamic
Flow | |
| Ophthalmic | Fetal | Abdominal | Intra-operative (Abdominal) | Intra-operative (Neuro) | Laparoscopic | Pediatric | Small Organ (Note 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) | Mode of Operation | | | | | | | | Other
-----|-------------------|---|-----|-----|------------------|-----------------------|-----|-----------------|---------------|
| M | PWD | CWD | Color
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| P | P | P | P | P | 3 | P | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | ! | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| P | P | P | P | P | 3 | P | | 4 |
| P | P | P | P | P | 3 | P | | 4 |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K082119

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

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

Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K091295

7

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

Aplio XG v4.0 SSA-790A System: _ 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 | 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 | 3 | P | P | P | | | 4 | |
| Cardiac Pediatric | | 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: K082119

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 (New) Note 8 STIC Note 9 3D color (New) (Division St Note 10 STIC Color (New)

Tony M. Whay

Division o oductive. Abdominal Radiolo 510(k) Numbe

8

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

Aplio_XG v4.0 SSA-790A System: __ PVT-375BT 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	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: K082119

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

logu In Wh

(Division oductive. Abdominal ar Radi 510(K)

9

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

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 | | N | N | N | | N | 2 | N | N | N | N | N | 5,7,8,9, |
| Abdominal | | N | N | N | | N | 2 | N | N | N | N | N | 5,7,8,9, |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | N | N | N | | N | 2 | N | N | N | N | N | 5,7,8,9, |
| 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: K082119

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

Signature

(Divisio roductive. Abdomina Divisio

10

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

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K082119

. ..

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 (New) Note 8 STIC (Divisi Note 9 3D color (New) Note 10 STIC Calor (New)

Prescription Use Only (Per 21 CRF801.109)

Argen M. White

oductive, Abdominal and Divisio Radiol 510(k) Number

11

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

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

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

. 0

| 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 | 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 | | | | | | | | | | | | |

N = new indication: P = previously cleared by FDA: E = added under this appendix Previous 510(k) of the transducer: K082119

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

Hona In Whang

Division of Reproductive, Abdominal and Radiologic 510(k) Number

12

Aplio XG v4.0 SSA-790A System: _ PVT-575MV___ 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
(Specify) | 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 | | | | | | | | | | | | | |
| 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: K082119

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 (New) Note 8 STIC (Division Note 9 3D color (New) oductive, Abdominal and Divisio Note 10 STIC Color (New)

Prescription Use Only (Per 21 CRF801.109)

B-10

Radiolo

510(k) N

13

Aplio XG v4.0 SSA-790A System: ______________________________________________________________________________________________________________________________________________________________________ PVT-674BT ____________________________________________________________________________________________________________________________________________________________________ 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 | 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: K082119

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 (New) Note 8 STIC (Division Si Note 9 3D color (New) Division of F Note 10 STIC Color (New)

Vorgu M. Whang

oductive. Abdominal and Radiologic 510(k) Number

14

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

.

Aplio XG v4.0 SSA-790A System: Transducer:_ PVT-661VT

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;
Power
Flow	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
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: K082119

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 B/M; B/PWD; BDF/MDF: BDF/M1)F/PWD: 2D/CWD; BDF/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging (New) (Division S Note 8 STIC Note 9 3D color (New) Note 10 STIC Color (New)

Prescription Use Only (Per 21 CRF801.109)

lonnie m. whiting

Division of Reproductive, Abdominal and Radiological 510(k) Numbe

15

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

System: Aplio XG v4.0 SSA-790A Transducer: PVT-68IMV

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 : (Specify) | 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 |
| 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: K082119

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: BPWD; BDF/MDF: BDF/MDF: BDF/MDF/Y WD
Note 3 Combined moludes BM: BPWD; BDF/MD; BDF/MDF: 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 (New) (Division Sign Note 8 STIC Division of Reproductive, Abdominal and Note 9 3D color (New) Note 10 STIC Color (New) Radiological De

ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

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

. .

Prescription Use Only (Per 21 CRF801.109)

510(k) Number

16

ָט

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

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 | | 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: K082119

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

(Division Sign-Off)

Division of Reproductive, Abdominal and

Radiological Devices

510(k) Number K091295

Prescription Use Only (Per 21 CRF801.109)

;

17

System: ______________________________________________________________________________________________________________________________________________________________________ Aplio XG v4.0 SSA-790A PVT-770RT 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)
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: K082119

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/C Note 4 TDI Note 5 ApliPure Note 6 MicroPure (Division Sign Note 7 Precision Imaging (New) Note 8 STIC Division of Reproductive. Abdomina Note 9 3D color (New) Radiolo Note 10 STIC Color (New) 510(k) Numbe

18

.0

Aplio XG v4.0 SSA-790A System: _ 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	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	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	P	2	P	P	P	P	5
Musculo-skelctal (Superficial)	P	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	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: K082119

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 (New) Note 8 STIC Note 9 3D color (New) Division of Reproductive, Abdominal as Note 10 STIC Color (New)

Prescription Use Only (Per 21 CRF801.109)

Radiolo

B-16

510(k) N

19

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

Aplio XG v4.0 SSA-790A System: Transducer: PLT-704AT

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 | 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) | | | | | | | | | | | | |

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/PW/20, 2D/CWD; BDF Note 4 TDI Note 5 ApliPure (Division Sign-Off Note 6 MicroPure Division of Reproductive, Abdominal and Note 7 Precision Imaging (New) Note 8 STIC Radiological Device Note 9 3D color (New) 510(k) Number Note 10 STIC Color (New)

20

ﮯ

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

System: ____________________________________________________________________________________________________________________________________________________________________ Transducer:_ PLT-704SBT

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)	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 SID(k) of the transducer: K082119

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/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging (New) (Division Note 8 STIC Division of Reproductive, Abdominal and Note 9 3D color (New) Note 10 STIC Color (New)

Prescription Use Only (Per 21 CRF801.(09)

Norri M. Whay

Radiological Devic 510(k) Number

21

Aplio XG v4.0 SSA-790A System: ____________________________________________________________________________________________________________________________________________________________________ PLT-705BTH _ 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	P	P	P		P	2	P P	P	P P	5
Intra-operative (Abdominal)	P	P	P		P	2	P P	P	P P	5
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P P	P	P P	5
Small Organ (Specify) (1)	P	P	P		P	2	P 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: K082119

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 (New) (Division Note 8 STIC Division of Reproductive, Abdominal and Note 9 3D color (New) Note 10 STIC Color (New) Radiolo

Prescription Use Only (Per 21 CRF801.109)

510(k) Number

22

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

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

Intended Use: Diagnostic ultrasound imaging or Nuid 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: K082119

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/MDF: BDF/MDF/PWD: 2D/CWD: BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging (New) (Division Sign-Off) Note 8 STIC Division of Reproductive, Abdominal and Note 9 3D color (New) Note 10 STIC Color (New) Radiological Devices

... .. ......

Prescription Use Only (Per 21 CRF801.109)

510(k) Number

Aomi M. Whan

Division Sign-Off)

23

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

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

| Clinical Application
Specific
(Tracks 3) | Mode of Operation | | | | | | | | | | | | Other
(Note) | |
|------------------------------------------------|-------------------|---|-----|-----|-------------------------------|----------|-----|-----------------|-------|-----------|----|--|-----------------|------|
| | B | M | PWD | CWD | Color
Doppler
(Specify) | Combined | 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 | P | | | | 5,6, |
| 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 | | | | 5,6, |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | P | | | | 5,6, |
| 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 | | | | 5,6, |

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

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

Previous 510(k) of the transducer: K082119

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: 20/CWD: BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure (Division Sign-Off) Note 7 Precision Imaging (New) Note 8 STIC Division of Reproductive. Abdominal and Note 9 3D color (New) Radiological De Note 10 STIC Color (New) 510(k) Number

Prescription Use Only (Per 21 CRF801.109)

. . . . . . . . . . .

24

. 0

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

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

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) | P | P | P | | P | 2 | P | P | P | | | 4,5 |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | | P | 2 | P | P | P | | | 4,5 |
| 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 | | | 4,5 |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | | | 4,5 |
| 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 | | | 4.5 |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K082119

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

(Division Sign-Off)

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

25

Aplio XG v4.0 SSA-790A · System: 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	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
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
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P	P	4,5,6
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: K082119

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 (New) Note 8 STIC Division of Reproductive, Abdominal and Note 9 3D color (New) Note 10 STIC Color (New) Radiological De

Prescription Use Only (Per 21 CRF801.109)

B-23

510(k) Number

26

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

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

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K082119

Note I Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M: B/PWD: BDF/PWD; BDF/MDF; BDF/MDF/YWD Note 3 Combined mode includes B/M; B/PWD: BDF/PWD; BDF/MDF; BDF/MDF/PWD: 2D/CWD; BDF/CWD Note 4 TD! Note S ApliPure Note 6 MicroPure Note 7 Precision Imaging (New) Note 8 STIC Note 9 3D color (New) roductive. Abdominal a Division of Note 10 STIC Color (New)

Prescription Use Only (Per 21 CRF801.109)

Radiolo 510(k) Number

27

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

. 0

System: __ _ Aplio XG v4.0 SSA-790A 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 | | |
| 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 | | |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | | 4,5,6 | | |
| 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: K082119

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 (New) (Division Sign-Off) Note 8 STIC Note 9 3D color (New) Note 10 STIC Color (New)

Prescription Use Only (Per 21 CRF801.109)

Division of Reproductive, Abdominal and Radiolo 510(k) Number

28

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

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

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) | P | P | P | | P | 2 | P | P | P | | | 4,5,6 |
| 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 |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | | | 4,5,6 |
| 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 |

N = new indication: P = previously cleared by FDA: E = added under this appendix Previous 510(k) of the transducer: K082119

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 (New) (Division Sigh-Off) Note 8 STIC Note 9 3D color (New) Note 10 STIC Color (New)

Prescription Use Only (Per 21 CRF801.109)

(Division Sigh-Off)
Division of Reproductive, Abdominal and
Radiological Devices,
510(k) Number K091295

29

Aplio XG v4.0 SSA-790A System: ______________________________________________________________________________________________________________________________________________________________________ PLT-1204MV__ 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)		P	P	P	P	2	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	5,7,9
Musculo-skeletal (Superficial)		P	P	P	P	2	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	5,7,9
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K082119

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: BD Note 4 TDI Note 5 ApliPure Note 6 MicroPure (Division Sign-Off) Note 7 Precision Imaging (New) Division of Reproductive, Abdominal and Note 8 STIC Note 9 3D color (New) Radiological Device Note 10 STIC Color (New) 510(k) Number

30

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

Aplio XG v4.0 SSA-790A System: _ Transducer:_ PET-SIOMB

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
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: K082119

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 Conbined mode includes B/M; B/PWD; BDF/PWD; BDF/MQF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure (Division Sign-O Note 7 Precision Imaging (New) Note 8 STIC Division of Reproductive, Abdominal and Note 9 3D color (New) Radiological I Note 10 STIC Color (New)

Prescription Use Only (Per 21 CRF801.109)

510(k) Number

31

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

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 | 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 | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K082119

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: BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging (New) Note 8 STIC (Division Sign-Off) Note 9 3D color (New) Reproductive, Abdominal and Note 10 STIC Color (New)

Division of Radiolog 510(k) Nu

32

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

Aplio XG v4.0 SSA-790A System: __ Transducer: PC-50M and the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution of the contribution of the fi

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 | | | | | | | | | | | | |
| 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 | | | |
| | | | | p | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |

N = new indication: P = previously cleared by FDA: E = added under this appendix Previous 510(k) of the transducer: K082119

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

Aorn In Nhang

(Division Sign-off)

Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K091295

Intended Use / Indications for Use

Product codes

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)

Reference Device(s)

Predetermined Change Control Plan (PCCP) - All Relevant Information

§ 892.1570 Diagnostic ultrasonic transducer.

510(k) Summary

Classification:

Identification of Predicate Devices:

Device Description:

lintendled Use:

Safety Considerations:

Transducer Model Number

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

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

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

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

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

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

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

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

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

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

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

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

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

System: ______________________________________________________________________________________________________________________________________________________________________ Transducer:___ PLT-704SBT

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

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

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

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

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

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

System: __ _ Aplio XG v4.0 SSA-790A Transducer:____ PLT-1204AX

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

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

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

Aplio XG v4.0 SSA-790A System: _ Transducer:_ PET-SIOMB

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

System: ____________________________________________________________________________________________________________________________________________________________________ Transducer:_ PLT-704SBT

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