APLIO MX SSA-780A, VERSION 1.0
Device Facts
| Record ID | K092948 |
|---|---|
| Device Name | APLIO MX SSA-780A, VERSION 1.0 |
| Applicant | Toshiba America Medical Systems, In.C |
| Product Code | IYN · Radiology |
| Decision Date | Oct 9, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The DIAGNOSTIC ULTRASOUND SYSTEM APLIO MX MODEL SSA-780A is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).
Device Story
Mobile diagnostic ultrasound system; employs wide array of probes (flat linear, convex linear, sector) with 2-12 MHz frequency range. Inputs: acoustic signals from patient body via transducers. Transformation: system processes echo/Doppler signals to generate real-time images and flow data. Outputs: visual display of ultrasound images/flow analysis for clinician review. Used in clinical settings by physicians/technicians. Output aids in diagnostic decision-making and patient assessment. Benefits: non-invasive visualization of internal structures and blood flow.
Clinical Evidence
Bench testing only. Device performance validated through compliance with international safety and performance standards for ultrasound systems (IEC 60601-1, 60601-1-1, 60601-1-2, 60601-1-4, 62304, AIUM-NEMA UD2, AIUM-NEMA UD3).
Technological Characteristics
Mobile ultrasound system; wide array of probes (linear, convex, sector); 2-12 MHz frequency range. Connectivity: standard ultrasound interface. Software: IEC 62304 compliant. Sterilization: compatible with standard transducer disinfection protocols. Energy: electrical. Imaging modes: B, M, PWD, CWD, Color Doppler, THI, Dynamic Flow, Power, CHI, 4D.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including fetal, abdominal, intraoperative, pediatric, small organ (thyroid, breast, testicle), neonatal/adult cephalic, transrectal, transvaginal, transesophageal, musculoskeletal, and peripheral vascular applications.
Regulatory Classification
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.
Predicate Devices
- Toshiba DIAGNOSTIC ULTRASOUND SYSTEM APLIO XG MODEL SSA-790A v4.0R001 (K092179)
- Toshiba DIAGNOSTIC ULTRASOUND SYSTEM APLIO XG MODEL SSA-790A v4.0 (K091295)
Reference Devices
- Xario XG SSA-680A (K072918)
Related Devices
- K131507 — XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM · Toshibamedical Systems Corporation · Aug 28, 2013
- K991858 — SSA-390A/POWER VISION 8000 · Toshiba America Medical Systems, In.C · Jun 16, 1999
- K133277 — XARIO 100 · Toshibamedical Systems Corporation · Jan 17, 2014
- K182427 — Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System · Canon Medical Systems Corporation · Nov 2, 2018
- K093171 — VIAMO SSA-640A VERSION 1.2 · Toshiba America Medical Systems, In.C · Dec 4, 2009
Submission Summary (Full Text)
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510{k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System
K092948
# 510(k) Summary
OCT - 9 2009
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
|-------------------|-------------------------------------------|
| Address: | 2441 Michelle Drive Tustin, CA 92780 |
| Contact: | Paul Biggins, Director Regulatory Affairs |
| Telephone No .: | (714) 730-5000 |
Device Proprietary Name:
DIAGNOSTIC ULTRASOUND SYSTEM APLIO MX MODEL SSA-780A Version 1.0
# Common Name:
Diagnostic Ultrasound System
# Classification:
- Regulatory Class: II .
- Review Category: Tier II .
- . Ultrasonic Pulsed Doppler Imaging System - Product Code: 90-IYN [Fed. Reg. No .: 892.1550]
- Ultrasonic Pulsed Echo Imaging System Product Code: 90-IYO . [Fed. Reg. No .: 892.1560]
- . Diagnostic Ultrasonic Transducer - Product Code: 90-ITX [Fed.Reg. No.: 892.1570]
# Identification of Predicate Devices:
Toshiba America Medical Systems believes that this device is substantially equivalent to:
- Toshiba DIAGNOSTIC ULTRASOUND SYSTEM APLIO XG MODEL SSA-790A 1. v4.0R001 - 510(k) K092179
- Toshiba DIAGNOSTIC ULTRASOUND SYSTEM APLIO XG MODEL SSA-790A v4.0 -2. 510(k) K091295
## Device Description:
The DIAGNOSTIC ULTRASOUND SYSTEM APLIO XG MODEL SSA-780A is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.
### Intended Use:
The DIAGNOSTIC ULTRASOUND SYSTEM APLIO MX MODEL SSA-780A is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).
### Declaration of Conformity:
This device is designed and manufactured in conjunction with the Quality System Regulation, IEC 60601-1 (applicable portions), IEC 60601-1-1 (applicable portion), IEC 60601-1-2 (applicable portion), IEC 60601-1-4 (applicable portion), IEC60601-2-37 (applicable portions), IEC 62304 (applicable portion) and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard.
{1}------------------------------------------------
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
OCT - 9 2009
Re: K092948
Trade/Device Name: Aplio MX v1.0 SSA-780A Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: September 23, 2009 Received: September 24, 2009
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling. and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Aplio MX v1.0 SSA-780A, as described in your premarket notification:
Transducer Model Number
| PST-25BT | PVT-375MV | PVT-681MV |
|-----------|-----------|------------|
| PST-30BT | PVT-382BT | PVT-745BTV |
| PST-50AT | PVT-382MV | PVT-770RT |
| PST-65AT | PVT-575MV | PLT-604AT |
| PST-20CT | PVT-674BT | PLT-704AT |
| PVT-375BT | PVT-661VT | PLT-704SBT |
{2}------------------------------------------------
| PLT-705BTH | PLT-1204A |
|------------|-----------|
| PLT-705BTF | PLT-1204B |
| PLT-805AT | PLT-1204M |
| PLT-1202S | PET-510M |
ਟ ਜਿ B
PET-508MA
PC-20M
PC-50M
If your device is classified (see above) into either class II (Special Controller)
it may be subject to such additional controls. Existing major regulations affective your d If your device is elassino (
it may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA
can be found in the Code of Feental Regulations, Title 21, Par it thay be stoget.
may publish further announcements concerning your device in the Federal Register.
may publish further announcements concerning your device in the Federal R
may publish untile and and Please be advised that FDA's issuance of a substantial equivalence of the Act
that FDA has made a determination that your device complies with of the Actives (21 Press of actives and regulations administered by other Foderal agencies. You must
that FDA has made a determination that such of coleral agencies. You must that FUA his made a works
or any Federal the Act regulations administered by other limited or resident of the many of the many of the may be as set of the setting of the seco or any redent states equirements, including, but not limited by tieststement as sed
CFR Part 807; labeling (21 CFR Part 80) ); good manufacturing practices and consected by a comply will an the Ace Part 801); good manufacturing practice todals and one of the electronic
CFR Part 807); abeling (21 CFR Part 801); and if applicable, the electronic
for CFR Part 607), March 3 (
forth in the quality systems (QS) regulation (21 CFR Part 820), and II approvinsions (2006).
product radiation control provisions (Sections 531-542
product taxiation on to begin marketing your device as described in your premarket.
This letter will of a line of substantial equivalence of your device to a legion to This letter will allow you to begin marketing your device in your device to a legally marketed
notification. The FDA finding of substantial equivalence of your device to I his telton. The FDA finding of substantial equivalence of your device to are a program.
predicate device results in a classification for your device and thus permits your proceed to market.
proceed to market.
If you desire specific advice for your device on our labeling regulation (11 CFR Part 801), please If you desire specific advice for your device on our labeling regulation (2) Control Concellent for for for for for for for for for for for for for alles pleases of the If you desire specifics and Radiological Health's (CDRH) office of Complexs
go to bittp://www.fdagogical Health's (CDRH's) Office of Company'' (2) CPF Pati
the Center for Dev go to bitp://www.fala.gov.com/ng by reference to premaket notification" (2) Prefer
the Center for Devices and, "Misbranding by reference to premarket notification" (2) (2) the United for Dorrest and
807.97). Por questions rogan o
CFR Part 803), please go to
http://www.fdc.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's Office
http://www.fdb.gov/ices CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/Nepostmarket Surveillance.
of Surveinalled and Dec.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.
Sincerely yours,
Heidi Lemun
Janine M. Morris Janine M. Morris
Acting Director, Division of Reproductive, Acting Director, Pradiological Devices Office of Device Evaluation Office of Device Evaruation
Center for Devices and Radiological Health
Enclosure(s)
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# 510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System
System: __Aplio MX v1.0 SSA-780A Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|------------------------------------|-------------------|---|-----|-----|------------------|------------------------|-----|-----------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | N | N | N | N | N | N | N | N | N | N | N | 5,7,8,9,10 |
| Abdominal | N | N | N | N | N | 2,3 | N | N | N | N | N | 5,7,8,9,10 |
| Intra-operative (Abdominal) | N | N | N | N | N | 2 | N | N | N | | | 4,5 |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | N | N | N | N | N | 2,3 | N | N | N | N | N | 5,7,8,9,10 |
| Small Organ (Note 1) | N | N | N | N | N | 2 | N | N | N | | | 4,5,6,7,9,1 |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | | | |
| Adult Cephalic | N | N | N | N | N | 3 | N | N | N | | | |
| Trans-rectal | N | N | N | N | N | 2 | N | N | N | | N | 4,5,7,11 |
| Trans-vaginal | N | N | N | N | N | 2 | N | N | N | | N | 4,5,7 |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | N | N | N | N | N | 2 | N | N | N | | | 4,5,6,7,9,1 |
| Musculo-skeletal (Superficial) | N | N | N | N | N | 2 | N | N | N | | | 4,5,6,7,9,1 |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | N | N | N | N | N | 3 | N | N | N | N | | 4 |
| Cardiac Pediatric | N | N | N | N | N | 3 | N | N | N | N | | 4 |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | N | N | N | N | N | 3 | N | | | | | 4 |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | N | N | N | N | N | 2 | N | N | N | | | 4,5,6,7,9,1 |
| Other (Specify) | | | | | | | | | | | | |
· N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging lim Note 8 STIC (Division Sign-Off) Note 9 3D Color (Volume Color) Division of Reproductive, Abdominal. Note 10 STIC Color and Radiological Device Note 11 Elastography
Prescription Use Only (Per 21 CRF801.109)
B-I
510(k) Number_
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# 510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System
#### System: Aplio MX v1.0 SSA-780A Transducer:_ PST-25BT
. .
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | P | P | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | P | P | | | |
| Small Organ (Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
| Adult Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | P | P | P | | 4 |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | P | | 4 |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD-Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI
Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging
Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography
Prescription Use Only (Per 21 CRF801.109)
Hleun
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devic
Radiological Devices
510(k) Number K092948
{5}------------------------------------------------
# 510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System
### System: __ Aplio MX v1.0 SSA-780A Transducer: PST-30BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Specific<br>(Tracks 3) | B | M | PWD CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note] |
|------------------------------------------------|---|---|---------|------------------|----------------------------|-----|-----------------|-------|-----------|----|-----------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | P | P | P | P | 3 | P | P | P | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | P | P | P | P | 3 | P | P | P | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | 3 | P | P | P | | | |
| Adult Cephalic | P | P | P | P | 3 | P | P | P | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | 3 | P | P | P | P | | 4 |
| Cardiac Pediatric | P | P | P | P | 3 | P | P | P | P | | 4 |
| Intravascular (Cardiac) | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510{k) of the transducer: K092179
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
Note 5 ApliPure
Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography
Hlen
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device
510(k) Number K092
{6}------------------------------------------------
## 510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System
Aplio MX v1.0 SSA-780A System: Transducer:_ PST-50AT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>(Note) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | | | | | 4 |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | | | | | 4 |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging (Division Sign-Off) Note 8 STIC Division of Reproductive, Abdominal, Note 9 3D Color (Volume Color) and Radiological Devic Note 10 STIC Color Note 11 Elastography 510(k) Number
{7}------------------------------------------------
## 510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System
System: Aplio MX v1.0 SSA-780A Transducer:_ _PST-65AT
Intended Use: Diagnostic ultrasound imaging or thiid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|------------------------|-----|-----------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | P | P | | | 4 |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | | | 4 |
| IPtravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF; BD/CWD; BDF/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Our Note 7 Precision Imaging (Division Sign-Off) Note 8 STIC Division of Reproductive, Abdominal, Note 9 3D Color (Volume Color) and Radiological Device Note 10 STIC Color 510(k) Number Note 11 Elastography Prescription Use Only (Per 21 CRF801.109)
B-5
{8}------------------------------------------------
# 510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System
System: Aplio MX v1.0 SSA-780A Transducer: PST-20CT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|-----------------------|-----|-----------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | P | P | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | P | P | | | |
| Small Organ (Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
| Adult Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | P | P | P | | 4 |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | P | | 4 |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 5 I 0(k) of the transducer: Letter filed as a compatible transducer to Xario XG SSA-680A VI. I K072918
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC (Division Sign-Off) Note 9 3D Color (Volume Color) Division of Reproductive, Abdominal Note 10 STIC Color Note 11 Elastography
eproductive, Abdominal,
and Radiological Devices
510(k) Number K092948
{9}------------------------------------------------
# 510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System
#### System: Aplio MX v1.0 SSA-780A Transducer: PVT-375BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|---|---------|------------------|------------------------|-----|-----------------|-------|-----------|----|-----------------|--|
| Specific<br>(Tracks 3) | B | M | PWD CWD | Color<br>Doppler | Combined<br>(Specify)* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note] | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | 2 | P | P | P | | | 5, 7 | |
| Abdominal | P | P | P | P | 2 | P | P | P | | | 5, 7 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | 2 | P | P | P | | | 5, 7 | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure 1111 Note 7 Precision Imaging (Division Sign Off) Note 8 STIC Division of Reproductive, Abdominal, Note 9 3D Color (Volume Color) and Radiological Devices Note 10 STIC Color Note 11 Elastography 510(k) Number
{10}------------------------------------------------
## 510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System
System: Aplio MX v1.0 SSA-780A Transducer: PVT-375MV
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Specific<br>(Tracks 3) | Mode of Operation | | | | | | | | | | | | |
|------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|-----------------|--|
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note] | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | P | 5,7,8,9,10 | |
| AbdomiPal | P | P | P | | P | 2 | P | P | P | | P | 5,7,8,9,10 | |
| IPtra-operative (AbdomiPal) | | | | | | | | | | | | | |
| IPtra-operative (Peuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | P | 5,7,8,9,10 | |
| Small Organ (Specify) (1) | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging 120 Note 8 STIC (Division Sign-Off) Note 9 3D Color (Volume Color) Division of Reproductive, Abdomi Note 10 STIC Color and Radiological Devic Note 11 Elastography 510(k) Number.
Prescription Use Only (Per 21 CRF801.109)
B-8
{11}------------------------------------------------
# 510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System
Aplio MX v1.0 SSA-780A System: Transducer: PVT-382BT
### Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | | 5 |
| AbdomiPal | P | P | P | | P | 2 | P | P | P | | | 5 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | | 5 |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC (Division Sign Off) Division of Reproductive, Abdominal Note 9 3D Color (Volume Color) Note 10 STIC Color and Radiological Devi
T.T.T
Note 11 Elastography
510(k) Number KD9274
{12}------------------------------------------------
# 510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System
System: Aplio MX v1.0 SSA-780A Transducer:_ PVT-382MV
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | P | 5,7 |
| Abdominal | P | P | P | | P | 2 | P | P | P | | P | 5,7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | P | 5,7 |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; DDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure Note 6 MicroPure
Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography
Hlen
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Device
510(k) Number K092948
{13}------------------------------------------------
# 510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System
#### System: Aplio MX v1.0 SSA-780A PVT-575MV Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | P | 5,7,8 |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro). | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K092179
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/M/F; B/DF/MDF/PWD; 2D/CWD; BDF/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure u Note 6 MicroPure (Division Sign-Off) Note 7 Precision Imaging Division of Reproductive, Abdominal Note 8 STIC and Radiological Device Note 9 3D Color (Volume Color) Note 10 STIC Color 510(k) Number Note 11 Elastography
{14}------------------------------------------------
# 510(k) Premarket Notification Aplio™ MX (v1.0) SSA-780A Ultrasound System
### Aplio MX v1.0 SSA-780A System: __ Transducer:_ PVT-674BT
..............................................................................................................................................................................
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | | 5 |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 5 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | | 5 |
| Small Organ (Specify) (1) | | |…
