APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSION 2.0
Device Facts
| Record ID | K072000 |
|---|---|
| Device Name | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSION 2.0 |
| Applicant | Toshiba America Medical Systems, In.C |
| Product Code | IYN · Radiology |
| Decision Date | Jul 30, 2007 |
| 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, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).
Device Story
The Aplio XG (Model SSA-790A, Version 2.00) is a mobile diagnostic ultrasound system. It utilizes a wide array of probes (linear, convex, sector) operating between 2 MHz and 12 MHz to acquire acoustic echo data. The system processes these inputs to generate B-mode, M-mode, Color Doppler, Power Doppler, Dynamic Flow, Tissue Doppler Imaging (TDI), Pulsed Wave (PW), and Continuous Wave (CW) Doppler outputs. Used in clinical settings by healthcare professionals, the device provides real-time visualization of internal structures and blood flow. Clinicians use these images to assess anatomy and pathology, supporting diagnostic decision-making. The system is designed to comply with Track 3 ultrasound standards for acoustic output and display.
Clinical Evidence
Bench testing only. The device was evaluated for safety and effectiveness through compliance with international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37) and AIUM-NEMA output measurement and display standards (UD2, UD3). 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. Track 3 system. Connectivity and software architecture are consistent with the predicate device (K063130).
Indications for Use
Indicated for diagnostic ultrasound imaging in fetal, abdominal, intraoperative, pediatric, small organ (thyroid, parathyroid, breast, scrotum, penis), neonatal/adult cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vascular, and musculoskeletal (conventional/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 SSA-790A, Aplio XG Version 1.00 Diagnostic Ultrasound (K063130)
- Siemens Medical Solutions U.S.A. Acuson Sequoia Ultrasound System (K052410)
Related Devices
- K081065 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2 · Toshiba America Medical Systems, In.C · Jun 6, 2008
- 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
- K063130 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0 · Toshibamedical Systems Corporation · Nov 2, 2006
- K022400 — SSA-700A, APLIO DIAGNOSTIC ULTRASOUND SYSTEM · Toshiba America Medical Systems, In.C · Aug 6, 2002
Submission Summary (Full Text)
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K072000
#### 510(k) Summarv 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 2.00 |
| Common Name: | Diagnostic Ultrasound System |
| | JUL 30 2001 |
| Classification: | |
| Regulatory Class: | II |
| Review Category: | Tier II |
| | Ultrasonic Pulsed Doppler Imaging System -- Product Code: 90-IYN<br>[Fed.Reg.No.:892.1550] |
| | Ultrasonic Pulsed Echo Imaging System - Product Code: 90-IYO<br>[Fed.Reg.No.:892.1560] |
| | Diagnostic Ultrasonic Transducer -- Product Code: 90-ITX<br>[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 1.00 Diagnostic Ultrasound; 510(k) control number k063130
- 2) Siemens Medical Solutions U.S.A. Acuson Sequoia Ultrasound System;510(k) control number k052410
#### Device Description:
The Aplio XG Ultrasound System is a mobile 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, 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 Ouality 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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird or eagle, with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 U 2007
Toshiba America Systems, Inc % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K072000
Trade Name: Aplio XG Diagnostic Ultrasound System, Model SSA-790A version 2.0 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 20, 2007 Received: July 23, 2007
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Aplio XG Diagnostic Ultrasound System, Model SSA-790A version 2.0, as described in your premarket notification:
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#### Transducer Model Number
| PVT-375BT | PLT-805AT | PST-50AT |
|-----------|------------|------------|
| PVT661VT | PLT-1204AT | PST-65AT |
| PLT-1202S | PLT-1204AX | PLT-704SBT |
| PC-20M | PVT-382BT | PLT-1204MV |
| PET-510MB | PVT-674BT | PVT-382MV |
| PST-25BT | PVT-575MV | PVT-681MV |
| PLT-604AT | PVT-770RT | PET-511BTM |
| PLT-704AT | PST-30BT | |
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.
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.
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Page 2 - Mr. Job
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,
Vopul Nithay for NCB
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 SSA-790A 510(k) Number(s)
STO(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) |
|----------------------------------|---|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | | P | | | | P |
| Abdominal | 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 |
| 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 | | | | | | | | | | | | |
| 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)
Combined Modes: B/M; B/PWD; Additional Comments: 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
All indications were previously reported via k063130
* : For example: thyroid, parathyroid, breast, scrotum and penis
(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)11
Jwhay
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
i
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System _ Transducer X Model___PVT-375BT 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 (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Previous 510(k) for this device k063130
(PLRASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
twhen
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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System Transducer X PVT-661 VT Model 510(k) Number(s)
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|----------------------------------|-------------------|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|
| | 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 | | | | | | | | | | | | |
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Previous 510(k) for this device k063130
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
JWhang
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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and the control control control control control of the control of
Transducer X System PLT-1202S Model 510(k) Number(s)
JTD(x) 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) | 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 |
indication; P Previously Cleared by FDA: E = Added under Appendix E (LTF)
Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD
Previous 510(k) for this device k063130
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
TWh
(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 Doppler | Power | Dynamic Flow | TDI | PW | CW | CHI 2D | CHI Dynamic Flow | Combined (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 | | | | | | | | | | | | |
| Superficial | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)Additional Comments:
Previous 510(k) for this device k063130
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JWhay
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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Transducer X System Model PET-510MB 510(k) Number(s)
-
| | | | | | | <b>Mode of Operation</b> | | | | | | |
|--------------------------|---|-----|---|---------------|-------|--------------------------|-----|----|----|--------|------------------|--------------------|
| Clinical Application | B | THI | M | Color Doppler | Power | Dynamic Flow | TDI | PW | CW | CHI 2D | CHI Dynamic Flow | Combined (Specify) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| 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 | | | | | | | | | | | | |
| 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 k063130
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) PM
Thhang
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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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<br>Dynamic<br>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 |
| 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 k063130
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
JWhay
(Division Sign-Off)
(Division of Reproductive, Abdomin Radiological Devices 510(k) Number
{11}------------------------------------------------
Transducer X System -PLT-604AT Model 510(k) Number(s)
e, 0 (π), π, ππ/6, π/4
| | 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/PWDPrevious 510(k) for this device k063130
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Jhway
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{12}------------------------------------------------
Transducer _X System Model PLT-704AT
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)* | E | E | E | E | E | E | | E | | | | E |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | E | E | E | E | E | E | | E | | | | E |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | E | E | E | E | E | E | | E | | | | E |
| Musculo-skeletal<br>Conventional | E | E | E | E | E | E | | E | | | | E |
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
> (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Thhay
(Division Sign-Off) Division of Reproductive, Abdominal an Radiological Devices 510(k) Number
{13}------------------------------------------------
Transducer X System PLT-805AT_____________________________________________________________________________________________________________________________________________________________________ Model 510(k) Number(s)
| Clinical Application | B | THI | M | Color Doppler | Power | Dynamic Flow | TDI | PW | CW | CHI 2D | CHI Dynamic Flow | Combined (Specify) | |
|----------------------------------|---|-----|---|---------------|-------|--------------|-----|----|----|--------|------------------|--------------------|---|
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify)* | E | E | E | E | E | E | | E | | | | | E |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral Vascular | E | E | E | E | E | E | | E | | | | | E |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | E | E | E | E | E | E | | E | | | | | E |
| Musculo-skeletal<br>Conventional | E | E | E | E | E | E | | E | | | | | E |
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
·
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Dhang
(Division Sign-Off)
Division of Reproductive, Abdominal a Radiological Devices 510(k) Number
{14}------------------------------------------------
and the contraction of the comments of the country of the country of the country of
System Transducer X
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)* | E | E | E | E | E | E | | E | | | | E |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | E | E | E | E | E | E | | E | | | | E |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | E | E | E | E | E | E | | E | | | | E |
| Musculo-skeletal<br>Conventional | E | E | E | E | E | E | | E | | | | E |
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
> (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)
Th
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K012000
{15}------------------------------------------------
______________________________________________________________________________________________________________________________________________________________________________
Transducer X System
PLT-1204AX 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 | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | | |
| Neurological | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify)* | E | E | E | E | E | E | | E | | | | | E |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral Vascular | E | E | E | E | E | E | | E | | | | | E |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal Superficial | E | E | E | E | E | E | | E | | | | | E |
| Musculo-skeletal Conventional | E | E | E | E | E | E | | E | | | | | E |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD and the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the first of t
> (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)
and the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of
Thly
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{16}------------------------------------------------
Transducer X System -PVT-382BT_____________________________________________________________________________________________________________________________________________________________________ Model 510(k) Number(s) . .
の 2007年の1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には1000年に1000000000000000000000000000000000000000000000000000000
| | | | | | | 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 | E | E | E | E | E | E | | E | | | | E | |
| Abdominal | E | E | E | E | E | E | | E | | | | E | |
| Intraoperative (Specify) | | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | | |
| Pediatric | E | E | E | E | E | E | | E | | | | E | |
| 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
> (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
DWh
(Division Sign-Off) Division of Reproductive, Abdominal a Radiological Devices 510(k) Number
{17}------------------------------------------------
Transducer X System PVT-674BT 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 | E | E | E | E | E | E | | E | | | | E |
| Abdominal | E | E | E | E | E | E | | E | | | | E |
| Intraoperative (Specify) | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| 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
> (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)
JWh
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{18}------------------------------------------------
Transducer X System Model PVT-575MV 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 | E | E | E | E | E | E | | E | | | | E |
| Fetal | E | E | E | E | E | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| 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 ================================================================================================================================================
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Th
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal Radiological Devices 510(k) Number
{19}------------------------------------------------
System Transducer X
PVT-770RT 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 | | | | | | | | | | |…
