APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2
Device Facts
| Record ID | K081065 |
|---|---|
| Device Name | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2 |
| Applicant | Toshiba America Medical Systems, In.C |
| Product Code | IYN · Radiology |
| Decision Date | Jun 6, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The Aplio XG 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 superficial).
Device Story
The Aplio XG (v2.2) is a mobile diagnostic ultrasound system. It utilizes various probes (linear, convex, sector) operating between 2-12 MHz to acquire acoustic signals. The system processes these inputs to generate B-mode, M-mode, Color Doppler, Power Doppler, Dynamic Flow, Tissue Doppler Imaging (TDI), Pulse Wave (PW), and Continuous Wave (CW) Doppler images. It is intended for use in clinical settings (e.g., clinics, hospitals) by trained healthcare professionals. The system provides real-time visualization and measurements, assisting clinicians in diagnostic assessment and clinical decision-making across multiple anatomical applications. The device benefits patients by providing non-invasive, real-time diagnostic imaging.
Clinical Evidence
Bench testing only. The device was evaluated for safety and effectiveness through compliance with recognized standards including IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and AIUM-NEMA UD2/UD3 output standards. No clinical data was required for this 510(k) clearance.
Technological Characteristics
Mobile diagnostic ultrasound system; frequency range 2-12 MHz; supports linear, convex, and sector array transducers. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and AIUM-NEMA UD2/UD3 standards. Connectivity includes standard ultrasound imaging interfaces. Sterilization is not applicable to the system console; transducers are cleaned/disinfected per manufacturer instructions.
Indications for Use
Indicated for fetal, abdominal, intraoperative, pediatric, small organ, neonatal/adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, and musculoskeletal (conventional/superficial) ultrasound imaging. Patient population includes all ages and genders requiring diagnostic ultrasound.
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 SSA-790A, Aplio XG Version 2.00 Diagnostic Ultrasound (K072000)
- General Electric Co. VOLUSON E8 Ultrasound System (K061682)
Related Devices
- K082119 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0 · Toshiba America Medical Systems, In.C · Aug 12, 2008
- K091295 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0 · Toshiba America Medical Systems, In.C · May 15, 2009
- K072000 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSION 2.0 · Toshiba America Medical Systems, In.C · Jul 30, 2007
- 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
Submission Summary (Full Text)
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JUN - 6 2008
#### 510(k) Summary of Safety and Effectiveness: 21 CFR 807.92
| 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 |
| | Device Proprietary Name: SSA-790A, Aplio XG Version 2.2 |
|--------------|---------------------------------------------------------|
| 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:
- 1. Toshiba SSA-790A, Aplio XG Version 2.00 Diagnostic Ultrasound; 510(k) K072000
- 2. General Electric Co. VOLUSON E8 Ultrasound System; 510(k) K061682
#### Device Description:
The Aplio XG Ultrasound System is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.
#### Intended Use:
The Aplio XG 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 superficial).
#### Safety Considerations:
This device is designed and manufactured in conjunction with the Quality System Regulation, IEC 60601-1 (applicable portions), IEC 60601-1-2 (applicable portion), IEC60601-2-37 (applicable portions), and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard.
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Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 2008
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K081065
Trade/Device Name: Aplio XG SSA-790A (v2.2) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 19, 2008 Received: May 21, 2008
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 SSA-790A (v2.2), as described in your premarket notification:
Transducer Model Number
PVT-375BT PVT-661VT PLT-1202S PC-20M PET-510MB PST-25BT
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PLT-604AT
PLT-704AT
PLT-805AT
PLT-1204AT
PLT-1204AX
PVT-382BT
PVT-674BT
PVT-575MV
PVT-770RT
PST-30BT
PST-50AT
PST-65AT
PLT-704SBT
PLT-1204MV
PVT-382MV
PVT-681MV
PET-511BTM
PC-50M
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 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
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The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
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 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 Lauren Hefner at (240) 276-3666.
Sincerely yours.
Arputh Whang
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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System X Transducer Model Aplio XG SSA-790A (v2.2) 510(k) Number(s)
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------|-------------------|-----|---|------------------|-------|-----------------|-----|----|----|-----------|---------------------|-----------------------|
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic Flow | Combined<br>(Specify) |
| Ophthalmic | | | | | | | | P | | | | P |
| Fetal | P | P | P | P | P | P | | P | | | | P |
| Abdominal | P | P | P | P | P | P | P | P | P | | | P |
| Intraoperative (Specify) | P | P | P | P | P | | | P | | | | P |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | | | P |
| Small Organ (Specify)* | P | P | P | P | P | | | P | | | | P |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | | | P |
| Adult Cephalic | P | P | P | P | P | P | | P | P | | | P |
| Cardiac | P | P | P | P | P | P | P | P | P | P | | P |
| Transesophageal | P | P | P | P | | | P | P | P | | | P |
| Transrectal | P | P | P | P | P | P | | P | | | | P |
| Transvaginal | P | P | P | P | P | P | | P | | | | P |
| Transurethral | | | | | | | | | | | | P |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | | P | P | | | P |
| Laparoscopic | | | | | | | | | | | | P |
| Musculo-skeletal<br>Superficial | P | P | P | P | P | P | | P | | | | P |
| Musculo-skeletal<br>Conventional | P | P | P | P | P | P | | P | | | | P |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD: BDF/MDF: BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEV2D; CHI/BDF; FEVBDF; FEVBDF
All indications were previously reported via k072000
* : For example: thyroid, parathyroid, breast, scrotum and penis
(PLEASE DO NOT WRITE BELOW THES LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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System Transducer _X PVT-375BT Model
510(k) Number(s)
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------|-------------------|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | | P | | | | P |
| Abdominal | P | P | P | P | P | P | | P | | | | P |
| Intraoperative (Specify) | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | | P | | | | P |
| Small Organ (Specify)* | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Previous 510(k) for this device k072000
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
hogar McWhay
(Division Sigh-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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Transducer X System -Model PVT-661VT 510(k) Number(s)
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------|-------------------|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify)* | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | P | P | P | P | P | P | | P | | | | P |
| Transvaginal | P | P | P | P | P | P | | P | | | | P |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Previous 510(k) for this device k072000
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Norval M. Ewing
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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Transducer _X System PLT-1202S Model 510(k) Number(s)
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify) |
|----------------------------------|---|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|
| Mode of Operation | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Specify) | P | P | P | P | P | | | P | | | | P |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify)* | P | P | P | P | P | | | P | | | | P |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | | | P | | | | P |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | P | P | P | P | P | | | P | | | | P |
| Musculo-skeletal<br>Conventional | P | P | P | P | P | | | P | | | | P |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Previous 510(k) for this device k072000
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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Transducer X System _ PC-20M _______________________________________________________________________________________________________________________________________________________________________ Model ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number(s)
| | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | P | | | |
| Small Organ (Specify)* | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | P | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | P | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | | |
| Conventional | | | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: _
Previous 510(k) for this device k072000
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Aosaita Wh
(Division Division of Reproductive, Abdomina Radiological Devices 510(k) Number
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Transducer X System PET-510MB ____________________________________________________________________________________________________________________________________________________________________ Model 510(k) Number(s)
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------|-------------------|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify)* | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | P | P | P | P | | | P | P | P | | | P |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | | |
| Superficial | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD;
Previous 510(k) for this device k072000
(PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
j
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
A-9
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Transducer _X System PST-25BT Model 510(k) Number(s)
.
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------|-------------------|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------|-----------------------|
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI Dynamic Flow | Combined<br>(Specify) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | P | P | | | P |
| Intraoperative (Specify) | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | | | P |
| Small Organ (Specify)* | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | | | P |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | | | P |
| Cardiac | P | P | P | P | P | P | P | P | P | P | | P |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | | |
| Superficial | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF; FEI/BDF
Previous 510(k) for this device k072000
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomse M. Whay
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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System Transducer X PLT-604AT_____________________________________________________________________________________________________________________________________________________________________ Model 510(k) Number(s)
1
| | Mode of Operation | | | | | | | | | | | | |
|----------------------------------|-------------------|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|---|
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify)* | P | P | P | P | P | P | | P | | | | | P |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | | P | | | | | P |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | P | P | P | P | P | P | | P | | | | | P |
| Musculo-skeletal<br>Conventional | P | P | P | P | P | P | | P | | | | | P |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Previous 510(k) for this device k072000
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
,
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Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{12}------------------------------------------------
Transducer X System PLT-704AT_____________________________________________________________________________________________________________________________________________________________________ Model 510(k) Number(s)
TO(K) Number(S)
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------|-------------------|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify)* | P | P | P | P | P | P | | P | | | | P |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | | P | | | | P |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | P | P | P | P | P | P | | P | | | | P |
| Musculo-skeletal<br>Conventional | P | P | P | P | P | P | | P | | | | P |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Previous 510(k) for this device k072000
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
.. ...
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Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{13}------------------------------------------------
Transducer _X System PLT-805AT Model 510(k) Number(s)
| | | Mode of Operation | | | | | | | | | | | |
|----------------------------------|---|-------------------|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|--|
| | | | | | | | | | | | | | |
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify)* | P | P | P | P | P | P | | P | | | | P | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | | P | | | | P | |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | P | P | P | P | P | P | | P | | | | P | |
| Musculo-skeletal<br>Conventional | P | P | P | P | P | P | | P | | | | P | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Previous \$10(k) for this device k072000
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Storm M. Weng
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{14}------------------------------------------------
Transducer X System PLT-1204AT Model 510(k) Number(s)
| | | Mode of Operation | | | | | | | | | | | |
|----------------------------------|---|-------------------|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|---|
| | | | | | | | | | | | | | |
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify)* | P | P | P | P | P | P | | P | | | | | P |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | | P | | | | | P |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | P | P | P | P | P | P | | P | | | | | P |
| Musculo-skeletal<br>Conventional | P | P | P | P | P | P | | P | | | | | P |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Previous 510(k) for this device k072000
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Aogru M. Wher
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{15}------------------------------------------------
System Transducer X PLT-1204AX Model ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number(s)
| | | Mode of Operation | | | | | | | | | | | |
|----------------------------------|---|-------------------|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|---|
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | | |
| Neurological | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify)* | P | P | P | P | P | P | | P | | | | | P |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | | P | | | | | P |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | P | P | P | P | P | P | | P | | | | | P |
| Musculo-skeletal<br>Conventional | P | P | P | P | P | P | | P | | | | | P |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Previous 510(k) for this device k072000
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
---
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{16}------------------------------------------------
Transducer _X System PVT-382BT_ Model 510(k) Number(s)
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------|-------------------|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | | P | | | | P |
| Abdominal | P | P | P | P | P | P | | P | | | | P |
| Intraoperative (Specify) | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | | P | | | | P |
| Small Organ (Specify)* | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | | |
| Superficial | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |
N= new indication; P= Previously Cleared by FDA; E= Added under Appendix E (LTE)N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Previous 510(k) for this device k072000
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{17}------------------------------------------------
System . Transducer X PVT-674BT Model 510(k) Number(s)
| | | Mode of Operation | | | | | | | | | | | |
|--------------------------|--------------------|-------------------|--|--|--|--|--|--|--|--|--|--|--|
| | | | | | | | | | | | | | |
| Clinical Application | | | | | | | | | | | | | |
| B | THI | | | | | | | | | | | | |
| M | Color Doppler | | | | | | | | | | | | |
| Power | Dynamic Flow | | | | | | | | | | | | |
| TDI | PW | | | | | | | | | | | | |
| CW | CHI 2D | | | | | | | | | | | | |
| CHI Dynamic Flow | Combined (Specify) | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | P | | | | | | | | | | | | |
| | P | | | | | | | | | | | | |
| | P | | | | | | | | | | | | |
| | P | | | | | | | | | | | | |
| | P | | | | | | | | | | | | |
| | P | | | | | | | | | | | | |
| | P | | | | | | | | | | | | |
| | P | | | | | | | | | | | | |
| Abdominal | P | | | | | | | | | | | | |
| | P | | | | | | | | | | | | |
| | P | | | | | | | | | | | | |
| | P | | | | | | | | | | | | |
| | P | | | | | | | | | | | | |
| | P | | | | | | | | | | | | |
| | P | | | | | | | | | | | | |
| | P | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | | |
| Neurological | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify)* | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | | | |
| Superficial | | | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | | | |
| Conventional | | | | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Previous 510(k) for this device k072000
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES (F NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
. I
Amme In Whang
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __
{18}------------------------------------------------
and the comments of the comments of the comments of the comments of the contribution of the first of the first of the first of the first of the first of the first of the firs
Transducer X System PVT-575MV Model 510(k) Number(s)
| | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|
| | | | | | | | | | | | | |
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | | P | | | | P |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify)* | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |…
