APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K121422 |
|---|---|
| Device Name | APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Toshiba Medical Systems Coporation, Japan |
| Product Code | IYO · Radiology |
| Decision Date | Aug 16, 2012 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The DIAGNOSTIC ULTRASOUND SYSTEM APLIO 500 MODEL TUS-A500, APLIO 400 MODEL TUS-A400 and APLIO 300 MODEL TUS-A300 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, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, and musculoskeletal (both conventional and superficial).
Device Story
Mobile diagnostic ultrasound system (Aplio 500/400/300 v2.1) utilizing various probes (linear, convex, sector) with 2-12 MHz frequency range. Inputs: ultrasonic echoes from human body structures/processes. Operation: system processes signals to generate B-mode, M-mode, PWD, CWD, Color Doppler, and combined modes (e.g., B/M, B/PWD, BDF/PWD, BDF/MDF/PWD, 2D/CWD). Outputs: real-time ultrasound images for clinical diagnosis. Used in clinical settings by physicians/technicians. Features include ApliPure, MicroPure, Precision Imaging, STIC, 3D Color, Elastography, Fusion, and 2D WMT. Output assists clinicians in visualizing anatomy and dynamic processes, supporting diagnostic decision-making and patient management.
Clinical Evidence
Bench testing only. Device conforms to 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 for Track 3 ultrasound systems.
Technological Characteristics
Mobile ultrasound system; probes include flat linear, convex, and sector arrays (2-12 MHz). Connectivity: standard ultrasound interfaces. 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 2D, 4D.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body in fetal, abdominal, intra-operative, pediatric, small organ (thyroid, breast, testicle), neonatal/adult cephalic, trans-rectal, trans-vaginal, cardiac (adult/pediatric/transesophageal), peripheral vascular, and musculoskeletal applications.
Regulatory Classification
Identification
An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Predicate Devices
- Toshiba DIAGNOSTIC ULTRASOUND SYSTEM APLIO 500 MODEL TUS-A500 / APLIO 400 MODEL TUS-A400 / APLIO 300 MODEL TUS-A300 V2.0 (K110870)
Submission Summary (Full Text)
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K121422
# 510(k) Summary of Safety and Effectiveness:
AUG 1 6 2012
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | PO Box 2068,2441 Michelle Drive Tustin, CA 92781-2068 |
| Contact: | Charlemagne Chua, Manager Regulatory Affairs |
| Telephone No.: | (714) 730-5000 |
| Device Proprietary Name: | DIAGNOSTIC ULTRASOUND SYSTEM<br>APLIO 500 MODEL TUS-A500 Version 2.1<br>APLIO 400 MODEL TUS-A400 Version 2.1<br>APLIO 300 MODEL TUS-A300 Version 2.1 |
| 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:
- l) Toshiba DIAGNOSTIC ULTRASOUND SYSTEM APLIO 500 MODEL TUS-A500 / APLIO 400 MODEL TUS-A400 / APLIO 300 MODEL TUS-A300 V2.0 ; 510(k) control number K110870
#### Device Description:
The DIAGNOSTIC ULTRASOUND SYSTEM APLIO 500 MODEL TUS-A500. APLIO 400 MODEL TUS-A400 and APLIO 300 MODEL TUS-A300 are mobile system. These systems are Track 3 devices that employ 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.
#### Indications for Use:
The DIAGNOSTIC ULTRASOUND SYSTEM APLIO 500 MODEL TUS-A500, APLIO 400 MODEL TUS-A400 and APLIO 300 MODEL TUS-A300 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, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, and musculoskeletal (both conventional and superficial).
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# Declaration of Conformity
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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.
# Standards form:
Please see the attached standard form of the IEC 60601-1-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37 and IEC 62304.
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized emblem. The emblem consists of a white eagle with its wings spread, superimposed over a blue background. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the emblem.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Toshiba Medical Systems Corporation, Japan % Mr. Charlemagne Chua Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780-2068
AUG 16 2012
Re: K121422
Trade/Device Name: Aplio™ 500/400/300 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 13, 2012 Received: July 16, 2012
Dear Mr. Chua:
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™ 500/400/300 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| PST-25BT | PVT-661VT | PVT-770RT | PLT-1204BT |
|-----------|------------|------------|------------|
| PST-30BT | PVT-674BT | PLT-604AT | PLT-1204BX |
| PST-50BT | PVT-675MV | PLT-704AT | PLT-1204MV |
| PST-65AT | PVT-681MV | PLT-704SBT | PET-508MA |
| PVT-375BT | PVT-712BT | PLT-705BTF | PET-510MB |
| PVT-375MV | PVT-745BTF | PVT-705BTH | PET-512MC |
| PVT-382BT | PVT-745BTH | PLT-805AT | PC-20M |
| PVT-382MV | PVT-745BTV | PLT-1202S | PC-50M |
{3}------------------------------------------------
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/CDRH/CDRHOffices/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/ReportaProblem/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 1 (301) 796-6524.
Sincerely Yours,
Michael D O'Shea for
Janine M. Morris Acting 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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# Indications for Use
510(k) Number (if known):
Device Name:
Aplio™ 500 /400/300 Diagnostic Ultrasound System
Indications for Use:
The DIAGNOSTIC ULTRASOUND SYSTEM APLIO 500 MODEL TUS-A500, APLIO 400 MODEL TUS-A400 and APLIO 300 MODEL TUS-A300 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, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, and musculoskeletal (both conventional and superficial).
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
---
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K124222
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#### 510(k) Premarket Notification Aplio™500(v2.1) TUS-A500 Ultrasound System
System: _ Aplio 300, Aplio 400, Aplio 500 v2.1 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 | | | | | P | 2 | P | P | P | | P | 5,7 |
| Fetal | P | P | P | P | P | 2 | P | P | P | | P | 5,7 |
| Abdominal | P | P | P | P | P | 2,3 | P | P | P | | P | 5,7,12 |
| Intra-operative (Abdominal) | P | P | P | P | P | 2 | P | P | P | | | 4,5 |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 2,3 | P | P | P | | P | 5,7,12 |
| Small Organ (Note 1) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,11 |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
| Adult Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
| Trans-rectal | P | P | P | P | P | 2 | P | P | P | | P | 4,5,7,11 |
| Trans-vaginal | P | P | P | P | P | 2 | P | P | P | | P | 4,5,7 |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,11 |
| Musculo-skeletal (Superficial) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,11 |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | P | P | P | | 4 |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | P | | 4 |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | P | P | P | P | P | 3 | P | | | | | 4 |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | 2 | P | P | P | | | 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: K110870
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
---
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro ation and Safety
510K K12.1422
Prescription Use Only (Per 21 CRF801.109)
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# 510(k) Premarket Notification Aplio™500(v2.1) TUS-A500 Ultrasound System
#### System: ______________________________________________________________________________________________________________________________________________________________________ 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 | | | 11 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | P | P | | | |
| Small Organ (Specify) (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 | | 4,13 |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | P | | 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: K110870
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT
516
Prescription Use Only (Per 21 CRF801.109)
(Division Sign-Off)
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### 510(k) Premarket Notification Aplio™500(v2.1) TUS-A500 Ultrasound System
#### System: _ Aplio 300, Aplio 400, Aplio 500 v2.1 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 | P | P | P | P | P | 3 | P | P | P | | | 11 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | P | P | | | |
| Small Organ (Specify) (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 | | 4,13 |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | P | | 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: K110870
Note 1 Small organ includes thyroid, breast and testicle.
Note 1 Small organ includes BM; B/PWD; BDF/PWD; BDF/PWD; BDF/A/DF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion
Note 13 2D WMT Prescription Use Only (Per 21 CRF801.109)
(Division Sign-Off)
of Radiological Devices
510
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#### 510(k) Premarket Notification Aplio™500(v2.1) TUS-A500 Ultrasound System
#### System: __ Aplio 300, Aplio 400, Aplio 500 v2.1 Transducer:__ PST-50BT
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 | E | E | E | E | E | 3 | E | E | E | | | 11 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | E | E | E | E | E | 3 | E | E | E | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | E | E | E | E | E | 3 | E | E | E | | | |
| Adult Cephalic | E | E | E | E | E | 3 | E | E | E | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | E | E | E | E | E | 3 | E | E | E | E | | 4,13 |
| Cardiac Pediatric | E | E | E | E | E | 3 | E | E | E | E | | 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: K090158
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 2 Combined mode includes BAN, BR WD, 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)
(Division Sign-Off)
Division of Radiological Devices
510k K121492
MAY 2012
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### 510(k) Premarket Notification Aplio™500(v2.1) TUS-A500 Ultrasound System
#### System: __ Aplio 300, Aplio 400, Aplio 500 v2.1 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 | Color<br>Doppler | Combined<br>(Specify)<br>* | TIII | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note] |
|------------------------------------------------|-------------------|---|---|-----|-----|------------------|----------------------------|------|-----------------|-------|-----------|------|-----------------|
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | E | E | E | E | E | 3 | E | E | E | | | 11 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | E | E | E | E | E | 3 | E | E | E | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | | |
| Neonatal Cephalic | E | E | E | E | E | 3 | E | E | E | | | | |
| Adult Cephalic | E | E | E | E | E | 3 | E | E | E | | | | |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | E | E | E | E | E | 3 | E | E | E | E | | 4,13 | |
| Cardiac Pediatric | E | E | E | E | E | 3 | E | E | E | E | | 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 I Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color
Note 11 Elastography · Note 12 Fusion Note 13 2D WMT
Prescription Use Only (Per 21 CRF801.109)
BealEBS
(Division Sign-Off)
on of Radiological
ﻟﻘﺎﺩ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
MAY 2012
{10}------------------------------------------------
#### 510(k) Premarket Notification Aplio™500(v2.1) TUS-A500 Ultrasound System
#### System: __Aplio 300, Aplio 400, Aplio 500 v2,1 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 | P | P | P | P | 2 | P | P | P | | | 5,7 |
| Abdominal | P | P | P | P | 2 | P | P | P | | | 5, 7,11,1 |
| Intra-operative (Abdominal) | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | P | P | P | P | 2 | P | P | P | | | 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: K110870
Note I Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT
Prescription Use Only (Per 21 CRF801.109)
*(Division Sign-Off)*
510(k): APLIO 500/400/300, v2.1 Page 194 of 3006
{11}------------------------------------------------
### 510(k) Premarket Notification Aplio™500(v2.1) TUS-A500 Ultrasound System
#### System: __ Aplio 300, Aplio 400, Aplio 500 v2.1 Transducer:_ PVT-375MV
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 | P | 2 | P | P | P | | N | 5,7,8,9,10 |
| Abdominal | P | P | P | P | P | 2 | P | P | P | | N | 5,7,8,9,10 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 2 | P | P | P | | N | 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<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: K103645
Note 1 Small organ includes thyroid, breast and testicle. Note 1 Small organ alstades arfrenz, e. BRWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT
Prescription Use Only (Per 21 CRF801.109)
A-7
{12}------------------------------------------------
### 510(k) Premarket Notification Aplio™500(v2.1) TUS-A500 Ultrasound System
#### System: __ Aplio 300, Aplio 400, Aplio 500 v2.1 Transducer:_ PVT-382BT
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 | P | 2 | P | P | P | | | | 5,7 | |
| Abdominal | P | P | P | P | P | 2 | P | P | P | | | | 5,7 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | |
| Pediatric | P | 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: 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 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)
Ruch D. 82
{13}------------------------------------------------
### 510(k) Premarket Notification Aplio™500(v2.1) TUS-A500 Ultrasound System
#### System: __Aplio 300, Aplio 400, Aplio 500 v2.1 Transducer: PVT-382MV
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 | P | 2 | P | P | P | | P | 5, 7,9 |
| Abdominal | | P | P | P | P | P | 2 | P | P | P | | P | 5, 7,9 |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | 2 | P | P | P | | P | 5,7,9 |
| Small Organ (Specify) (1) | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix ·Previous 510(k) of the transducer: 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 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)
(Division Sign-Off)
Division of Radiological Devices
and
A-9 -
{14}------------------------------------------------
### 510(k) Premarket Notification Aplio™500(v2.1) TUS-A500 Ultrasound System
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)<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) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | P | P | P | P | P | 2 | P | P | P | | | 4,5,7,11 |
| Trans-vaginal | P | P | P | P | P | 2 | P | P | P | | | 4,5,7,11 |
| 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: K110870
Note 1 Small organ includes thyroid, breast and testicle. .
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT .
Prescription Use Only (Per 21 CRF801.109)
vision Sion-Off
ological Devices
{15}------------------------------------------------
#### 510(k) Premarket Notification Aplio™500(v2.1) TUS-A500 Ultrasound System
#### System: _ Aplio 300, Aplio 400, Aplio 500 v2.1 Transducer: PVT-674BT
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 | | | 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 | | | | | |…
