APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0
Device Facts
| Record ID | K091295 |
|---|---|
| Device Name | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0 |
| Applicant | Toshiba America Medical Systems, In.C |
| Product Code | ITX · Radiology |
| Decision Date | May 15, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1570 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended 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).
Device Story
The Aplio XG v4.0 is a mobile diagnostic ultrasound system. It utilizes a wide array of probes (linear, convex, sector) with frequencies from 2 MHz to 12 MHz to acquire ultrasound images and fluid flow data. The system processes these inputs to produce B-mode, M-mode, Pulsed/Continuous Wave Doppler, Color Doppler, and combined modes (e.g., THI, Dynamic Flow, Power, CHI, 3D). It is used in clinical settings by healthcare professionals for diagnostic imaging. The output is displayed for clinician review to support clinical decision-making in various anatomical studies. The device benefits patients by providing non-invasive diagnostic visualization of internal structures and blood flow.
Clinical Evidence
Bench testing only. The device complies with safety standards including IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 62304, and AIUM-NEMA UD2/UD3 output standards for Track 3 ultrasound systems.
Technological Characteristics
Mobile ultrasound system; probes include flat linear, convex, and sector arrays (2-12 MHz). Modes: B, M, PWD, CWD, Color Doppler, THI, Dynamic Flow, Power, CHI, 3D. Complies with IEC 60601-1, IEC 62304, and AIUM-NEMA UD2/UD3 standards. Software-based image processing.
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, peripheral vascular, and musculoskeletal applications.
Regulatory Classification
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.
Predicate Devices
- Toshiba Ultrasound Diagnostic System Aplio XG MODEL SSA-790A V3.0 (K082119)
Related Devices
- K082119 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0 · Toshiba America Medical Systems, In.C · Aug 12, 2008
- K081065 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2 · Toshiba America Medical Systems, In.C · Jun 6, 2008
- K063130 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0 · Toshibamedical Systems Corporation · Nov 2, 2006
- K092179 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001 · Toshiba America Medical Systems, In.C · Jul 29, 2009
- K072000 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSION 2.0 · Toshiba America Medical Systems, In.C · Jul 30, 2007
Submission Summary (Full Text)
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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
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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 |
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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.
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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<br>(Tracks 3) | B | | M 'PWD:CWD | | Color | Combined THI Dynamic Power<br>Doppler . (Specify) | | Flow | | CHI<br>2D | 4 D | Other<br>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<br>(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
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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<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler<br>(Specify) | Combined | THI | Dynamic<br>Flow | Power<br>CHI<br>2D | 4D | Other<br>[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<br>(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
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## 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<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | THI | Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>[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<br>(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
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## 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 | Mode of Operation | | | | | | | | Other<br>Note |
|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|-----|-----------------|---------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | THI | Dynamic<br>Flow | |
| 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<br>(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: 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
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## 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<br>Specific<br>(Tracks 3) | Mode of Operation | B | M | PWD:CWD<br>Color<br>Doppler | Combined<br>(Specify) | THI | Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>(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<br>(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<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | THI | Dynamic<br>Flow | Power | CHI<br>2D | 3D | 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<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: 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<br>Specific<br>(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | THI | Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>(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<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: 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<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>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<br>(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<br>Specific<br>(Tracks 3) | Mode of Operation | B | M | PWD CWD | Color<br>Doppler | Combined<br>(Specify) | THI | Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>(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<br>(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<br>Specific<br>(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Color<br>Doppler<br>(Specify) | Combined<br>(Specify) | THI | Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>[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<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: 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<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>(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<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: 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<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | THI | Dynamic;<br>Power<br>Flow | CHI<br>2D | 3D | Other<br>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…
