APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K110870 |
|---|---|
| Device Name | APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Toshiba America Medical Systems, In.C |
| Product Code | IYN · Radiology |
| Decision Date | Oct 4, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The system is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and sugerficial).
Device Story
Mobile diagnostic ultrasound system (Aplio 500/400/300 v2.0) utilizing wide array of probes (linear, convex, sector; 2-12 MHz). System processes acoustic signals to generate B-mode, M-mode, Pulsed Wave Doppler (PWD), Continuous Wave Doppler (CWD), Color Doppler, and combined modes. Features include ApliPure, MicroPure, Precision Imaging, Elastography, Fusion, and 2D WMT. Operated by clinicians in clinical settings for diagnostic imaging and fluid flow analysis. Output displayed on system monitor for real-time visualization and clinical decision-making. Supports various clinical applications including cardiac, vascular, and fetal imaging. Benefits include non-invasive diagnostic visualization of internal structures and dynamic processes.
Clinical Evidence
Bench testing only. Compliance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37, IEC 62304, and AIUM-NEMA UD2/UD3 standards. No clinical data provided.
Technological Characteristics
Mobile ultrasound system; probes include flat linear, convex, and sector arrays (2-12 MHz). Modes: B, M, PWD, CWD, Color Doppler, THI, TDI, ApliPure, MicroPure, Precision Imaging, Elastography, Fusion, 2D WMT. Connectivity: Standalone/networked. Software: IEC 62304 compliant. Sterilization: Probes compatible with standard clinical disinfection protocols.
Indications for Use
Indicated for visualization of structures and dynamic processes within the human body using ultrasound for diagnostic imaging in fetal, abdominal, pediatric, small organs, trans-vaginal, neonatal cephalic, adult cephalic, cardiac, peripheral vascular, transesophageal, and musculo-skeletal (conventional and superficial) 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 System Aplio XG SSA-790A v5.2 (K103645)
- Toshiba Diagnostic Ultrasound system Aplio Artida SSH-880A v2.0 (K090158)
- General Electric LOGIC E.9 Ultrasound System (K092271)
Related Devices
- K121422 — APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM · Toshiba Medical Systems Coporation, Japan · Aug 16, 2012
- K133761 — APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0 · Toshibamedical Systems Corporation · Apr 22, 2014
- K041499 — SSA-770A, APLIO VERSION 5.5 · Toshibamedical Systems Corporation · Jun 10, 2004
- K191663 — Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 · Canon Medical Systems Corporation · Sep 18, 2019
- K123992 — APLIO 500/400/300 V3.0 · Toshibamedical Systems Corporation · Feb 6, 2013
Submission Summary (Full Text)
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Aplio™ TUS-A300/400/500 (v2.0)
OCT - 4 2011
## 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 Preparation Date: September 30, 2011 Device Proprietary Name: Diagnostic Ultrasound System Aplio 500 Model TUS-A500 Version 2.0 Aplio 400 Model TUS-A400 Version 2.0 Aplio 300 Model TUS-A300 Version 2.0 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:
- K 103645 Toshiba Diagnostic System Aplio XG SSA-790A v5.2 .
- K090158 Toshiba Diagnostic Ultrasound system Aplio Artida SSH-880A v2.0 ●
- K092271 General Electric LOGIC E.9 Ultrasound System .
## Device Description:
The Aplio 500/400/300 system is a mobile ultrasound system. It 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. The Aplio 500/400/300 is designed to support a wide rauge of applications depending on which software is installed. The system can be a dedicated system or a eneral purpose system.
## Intended Use:
The system is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and sugerficial).
#### 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),
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and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard.
Testing has been conducted per the following standards:
- . IEC 60601-1-1
- IEC 60601-1 .
- . IEC 60601-2-37
- . IEC 60601-1-4
- . IEC 62304
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle, there is an emblem featuring a stylized depiction of a bird or eagle with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
. . . .
OCT - 4 2011
Re: K110870
Trade/Device Name: Aplio TUS-A500/A400/A300 (v2.0) Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Il Product Code: 1YO. IYN, and ITX Dated: August 10, 2011 Received: August 11, 2011
Dear Mr. Biggins:
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 TUS-A500/A400/A300 (v2.0) Diagnostic Ultrasound System, as described in your premarket notification:
| PLT-1202S | PST-25BT | PVT-674BT |
|------------|-----------|------------|
| PLT-1204BT | PST-30BT | PVT-675MV |
| PLT-1204BX | PVT-375BT | PVT-681MV |
| PLT-1204MV | PVT-375MV | PLT-712BT |
| PET-510MB | PVT-382BT | PLT-745BTV |
| PC-20M | PVT-382MV | PLT-704BT |
| PC-50M | PVT-661VT | PLT-805AT |
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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Joshua Nipper at (301) 796-6524.
Sincerely Yours,
Mary Stoth
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
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#### K 110870 510(K) Number (if known):
Device Name: Aplio TUS-A500/A400/A300 (v2.0) Diagnostic Ultrasound System
## Indications for Use:
The Aplio TUS-A500/A400/A300 (v2.0) Diagnostic Ultrasound System is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, small organs, trans-vaginal, neonatal cephalic, adult cephalic, cardiac, peripheral vascular, transesophageal, and musculo-skeletal (both conventional and superficial).
Prescription Use_
AND/OR
Over-the Counter Use (21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Shiotl
Radiological Devices Division of Office of in Vitro D
K110870
510K
COMPANY CONFIDENTIAL MAR 2011
B-I
510(k): Aplio TUS-A500/400/300 (V2.0) Page 164 of 3030
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#### System: _Aplio TUS-A500/A400/A300 v2.0 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 | 2 | N | N | N | N | N | 5,7 |
| Abdominal | N | N | N | N | N | 2,3 | N | N | N | N | N | 5,7,12 |
| Intra-operative (Abdominal) | N | N | N | N | N | 2 | N | N | N | N | | 4,5 |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric* | N | N | N | N | N | 2,3 | N | N | N | N | N | 5,7,12 |
| Small Organ (Note 1) | N | N | N | N | N | 2 | N | N | N | N | | 4,5,6,7,11 |
| Neonatal Cephalic | N | N | N | N | N | 3 | N | N | N | N | | |
| Adult Cephalic | N | N | N | N | N | 3 | N | N | N | N | | |
| Trans-rectal | N | N | N | N | N | 2 | N | N | N | N | N | 4,5,7,11 |
| Trans-vaginal | N | N | N | N | N | 2 | N | 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 | N | | 4,5,6,7,11 |
| Musculo-skeletal (Superficial) | N | N | N | N | N | 2 | N | N | N | N | | 4,5,6,7,11 |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | N | N | N | N | N | 3 | N | N | N | N | N | 4 |
| Cardiac Pediatric | N | N | N | N | N | 3 | N | 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 | N | | 4,5,6,7,11 |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Previous 510(k) of the transducer: K103645
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
- Note 12 Fusion
Note 13 2D WMT
Prescription Use Only (Per 21 CRF801.109)
Mary S. Posth
(Division Sign Off)
Division of Radiological Device Office of In Vitro Division of nazioning of Includion
K110870
510K
COMPANY CONFIDENTIAL MAR 2011
B-2
510(k): Aplio TUS-A500/400/300 (V2.0) Page 165 of 3030
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#### 510(k) Premarket Notification Aplio™500(v2.0) TUS-A500 Ultrasound System
Aplio TUS-A500/A400/A300 v2.0 System: _ Transducer:_ PLT-1202S
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) | N | N | N | N | N | 2 | N | | N | | | 4,5,11 |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | N | N | N | N | N | 2 | N | | N | | | 4,5,11 |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | N | N | N | N | N | 2 | N | | N | | | 4,5,11 |
| Musculo-skeletal (Superficial) | N | N | N | N | N | 2 | N | | N | | | 4,5,11 |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | N | N | N | N | N | 2 | N | | N | | | 4,5,11 |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K103645
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 Note 12 Fusion Note 13 2D WMT
Prescription Use Only (Per 21 CRF801.109)
Mary S. Posth
Division of Radiological Devic Office of In
510K K110870
B-17
COMPANY CONFIDENTIAL MAR 2011
510(k): Aplio TUS-A500/400/300 (V2.0) Page 180 of 3030
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#### 510(k) Premarket Notification Aplio™500(v2.0) TUS-A500 Ultrasound System
. --
System: _Aplio TUS-A500/A400/A300 v2.0 Transducer:_____ PLT-1204BT
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 (Specify) (1) | N | N | N | N | N | 2 | N | N | N | | | 4,5,6,7,1 | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | N | N | N | N | N | 2 | N | N | N | | | 4,5,6,7,1 | |
| Musculo-skeletal (Superficial) | N | N | N | N | N | 2 | N | N | N | | | 4,5,6,7,1 | |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | N | N | N | N | N | 2 | N | N | N | | | 4,5,6,7,1 | |
| Other (Specify) | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K103645
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 13 2D WMT
- Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion
Mary S Patel
(Division Sign-Off)
Division of Aadiological Devices stic Device Evaluation and Safety Office of In Vitro Diagno
K110870
510K
Prescription Use Only (Per 21 CRF801.109)
B-18
COMPANY CONFIDENTIAL MAR 2011
510(k): Aplio TUS-A500/400/300 (V2.0) Page 181 of 3030
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#### 510(k) Premarket Notification Aplio™500(v2.0) TUS-A500 Ultrasound System
System: _ Aplio TUS-A500 v2.0 Transducer:____PLT-1204BX
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 (Specify) (1) | N | N | N | N | N | 2 | N | N | N | | | 5,7 |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | N | N | N | N | N | 2 | N | N | N | | | 5,7 |
| Musculo-skeletal (Superficial) | N | N | N | N | N | 2 | N | N | N | | | 5.7 |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | N | N | N | N | N | 2 | N | N | N | | | 5,7 |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K103645
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
Note 12 Fusion
Note 13 2D WMT
Prescription Use Only (Per 21 CRF801.109)
Mary Statel
(Division Sign-Off)
Office of In
510K K110870
B-19
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#### 510(k) Premarket Notification Aplio™500(v2.0) TUS-A500 Ultrasound System
System: _ Aplio TUS-A500/A400/A300 v2.0 Transducer:___PLT-1204MV
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 (Specify) (1) | N | N | N | N | N | 2 | N | N | N | | N | 5,7,8,9,1 | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | N | N | N | N | N | 2 | N | N | N | | N | 5,7,8,9,1 | |
| Musculo-skeletal (Superficial) | N | N | N | N | N | 2 | N | N | N | | N | 5,7,8,9,1 | |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | N | N | N | N | N | 2 | N | N | N | | N | 5,7,8,9,1 | |
| Other (Specify) | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K103645
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 Note 12 Fusion
- Note 13 2D WMT
Mary S. Pastel
ADVISION Sign-Off ivision of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110870
Prescription Use Only (Per 21 CRF801.109)
B-20
COMPANY CONFIDENTIAL MAR 2011
510(k): Aplio TUS-A500/400/300 (V2.0) Page 183 of 3030
{10}------------------------------------------------
#### 510(k) Premarket Notification Aplio™500(v2.0) TUS-A500 Ultrasound System
System: _Aplio TUS-A500/A400/A300 v2.0 Transducer:_ PET-510MB
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 | | | | | | | | | | | | | |
| 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) | N | N | N | N | N | 3 | N | | | | | | 4,13 |
| 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: K103645
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
Note 12 Fusion Note 13 2D WMT
Mary S. Patel
Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
K110870
510K
Prescription Use Only (Per 21 CRF801.109)
B-21
COMPANY CONFIDENTIAL MAR 2011
510(k): Aplio TUS-A500/400/300 (V2.0) Page 184 of 3030
{11}------------------------------------------------
#### 510(k) Premarket Notification Aplio™500(v2.0) TUS-A500 Ultrasound System
System: Aplio TUS-A500/A400/A300 v2.0 Transducer: PC-20M
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 | | | | | | | | | | | | |
| 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 | | | | N | | | | | | | | |
| Cardiac Pediatric | | | | N | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | N | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K103645
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes 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 Note 12 Fusion Note 13 2D WMT
Mary S. Poole
(Division Sign-Off)
Division of Radiological Devices Office of In
510K K110870
Prescription Use Only (Per 21 CRF801.109)
B-22
COMPANY CONFIDENTIAL MAR 2011
510(k): Aplio TUS-A500/400/300 (V2.0) Page 185 of 3030
{12}------------------------------------------------
#### 510(k) Premarket Notification Aplio™500(v2.0) TUS-A500 Ultrasound System
System: Aplio TUS-A500/A400/A300 v2.0 Transducer: PC-50M
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 | | | | | | | | | | | | | |
| 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 | | | | N | | | | | | | | | |
| Cardiac Pediatric | | | | N | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | | | | N | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K103645
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 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
· Note 12 Fusion
Note 13 2D WMT
Prescription Use Only (Per 21 CRF801.109)
Mary S. Patel
vision Sign-Off) Division of Radiological Devices ice Evaluation and Safety Office of In Vitro Diag
510K K110870
cription Use Only (ref 21 CRF 801.109)
B-23
COMPANY CONFIDENTIAL MAR 2011
510(k): Aplio TUS-A500/400/300 (V2.0) Page 186 of 3030
Note 4 TDI
{13}------------------------------------------------
## 510(k) Premarket Notification Aplio™ TUS-A500/300/200 (v2.0)
System: Aplio TUS-A500/A400/A300 v2.0 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 | N | N | N | N | N | 3 | N | N | N | | | 11 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | N | N | N | N | N | 3 | N | N | N | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | N | N | N | N | N | 3 | N | N | N | | | |
| Adult Cephalic | N | N | N | N | N | 3 | N | N | N | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | N | N | N | N | N | 3 | N | N | N | N | | 4,13 |
| Cardiac Pediatric | N | N | N | N | N | 3 | N | N | N | N | | 4,13 |
| 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: K103645
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 Note 12 Fusion Note 13 2D WMT
Mary S. Poole
(Division Sign-Off)
Division of Radiological Devices aluation and Safety Office of In Vitro Diagnos
510K H110870
COMPANY CONFIDENTIAL MAR 2011
Prescription Use Only (Per 21 CRF801.109)
B-3
510(k): Aplio TUS-A500/400/300 (V2.0) Page 166 of 3030
{14}------------------------------------------------
## 510(k) Premarket Notification Aplio™ TUS-A500/300/200 (v2.0)
System: Aplio TUS-A500/A400/A300 v2.0 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)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | N | N | N | N | N | 3 | N | N | N | | | 11 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | N | N | N | N | N | 3 | N | N | N | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | N | N | N | N | N | 3 | N | N | N | | | |
| Adult Cephalic | N | N | N | N | N | 3 | N | N | N | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | N | N | N | N | N | 3 | N | N | N | N | | 4,13 |
| Cardiac Pediatric | N | N | N | N | N | 3 | N | N | N | N | | 4,13 |
| 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: K103645
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 (Division Sign-Off, Note 11 Elastography Note 12 Fusion Note 13 2D WMT
Prescription Use Only (Per 21 CRF801.109)
Mary Stastil
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K H110870
COMPANY CONFIDENTIAL MAR 2011
B-4
510(k): Aplio TUS-A500/400/300 (V2.0) Page 167 of 3030
{15}------------------------------------------------
## 510(k) Premarket Notification Aplio™ TUS-A500/300/200 (v2.0)
System: _Aplio_TUS-A500/A400/A300 v2.0 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)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | N | N | N | N | N | 2 | N | N | N | | | 5,7 |
| Abdominal | N | N | N | N | N | 2 | N | N | N | | | 5, 7,11,12 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | N | N | N | N | N | 2 | N | N | N | | | 5, 7,12 |
| 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: K103645
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 N…
