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K Number
K081065
Device Name
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2
Manufacturer
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
Date Cleared
2008-06-06

(52 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
More Information

K072000, K061682

Not Found

No
The document does not mention AI, ML, or related terms, nor does it describe any features or performance metrics typically associated with AI/ML-powered devices.

No
The device is described as a "Diagnostic Ultrasound" system, and its intended uses are for various types of studies (e.g., fetal, abdominal), which are diagnostic rather than therapeutic procedures.

No
The provided text does not contain explicit claims or descriptions of the device performing diagnostic functions (e.g., detecting, identifying, or characterizing diseases or conditions). It lists various types of studies for which the device is intended, but these describe applications rather than the device's diagnostic capabilities. The predicate device mentions "Diagnostic Ultrasound," but this refers to the predicate and not a direct claim about the Aplio XG in the provided text.

No

The device description explicitly states it is a "mobile system" and employs "a wide array of probes," which are hardware components.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD devices are used to examine specimens obtained from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
  • The Aplio XG is an ultrasound system. Ultrasound systems use sound waves to create images of internal body structures. They are used for imaging within the body, not for analyzing samples taken from the body.

The provided information clearly describes a diagnostic imaging device, not a device for in vitro analysis of biological specimens.

N/A

Intended Use / Indications for 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).

Product codes

90-IYN, 90-IYO, 90-ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Diagnostic Ultrasound

Anatomical Site

Fetal, abdominal, intraoperative, pediatric, small organs (e.g., thyroid, parathyroid, breast, scrotum and penis), neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, musculo-skeletal (both conventional and superficial).

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K072000, K061682

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.

0

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
    1. 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.

1

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

2

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.

3

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)

4

System X Transducer Model Aplio XG SSA-790A (v2.2) 510(k) Number(s)

Mode of Operation
Clinical ApplicationBTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI
Dynamic FlowCombined
(Specify)
OphthalmicPP
FetalPPPPPPPP
AbdominalPPPPPPPPPP
Intraoperative (Specify)PPPPPPP
Intraoperative
Neurological
PediatricPPPPPPPPPP
Small Organ (Specify)*PPPPPPP
Neonatal CephalicPPPPPPPPPP
Adult CephalicPPPPPPPPP
CardiacPPPPPPPPPPP
TransesophagealPPPPPPPP
TransrectalPPPPPPPP
TransvaginalPPPPPPPP
TransurethralP
Intravascular
Peripheral VascularPPPPPPPPP
LaparoscopicP
Musculo-skeletal
SuperficialPPPPPPPP
Musculo-skeletal
ConventionalPPPPPPPP

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

5

System Transducer _X PVT-375BT Model

510(k) Number(s)

Mode of Operation
Clinical ApplicationBTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI
Dynamic
FlowCombined
(Specify)
Ophthalmic
FetalPPPPPPPP
AbdominalPPPPPPPP
Intraoperative (Specify)
Intraoperative
Neurological
PediatricPPPPPPPP
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 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

6

Transducer X System -Model PVT-661VT 510(k) Number(s)

Mode of Operation
Clinical ApplicationBTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI
Dynamic
FlowCombined
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
TransrectalPPPPPPPP
TransvaginalPPPPPPPP
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 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

7

Transducer _X System PLT-1202S 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) |
|----------------------------------|---|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|
| Mode of Operation | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Specify) | P | P | P | P | P | | | P | | | | P |
| Intraoperative
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
Superficial | P | P | P | P | P | | | P | | | | P |
| Musculo-skeletal
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

8

Transducer X System _ PC-20M _______________________________________________________________________________________________________________________________________________________________________ Model ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number(s)

Mode of Operation
Clinical ApplicationBTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI
Dynamic
FlowCombined
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
PediatricP
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
CardiacP
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularP
Laparoscopic
Musculo-skeletal
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

9

Transducer X System PET-510MB ____________________________________________________________________________________________________________________________________________________________________ Model 510(k) Number(s)

Mode of Operation
Clinical ApplicationBTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI
Dynamic
FlowCombined
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac
TransesophagealPPPPPPPP
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 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

10

Transducer _X System PST-25BT Model 510(k) Number(s)

.

Mode of Operation
Clinical ApplicationBTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI Dynamic FlowCombined
(Specify)
Ophthalmic
Fetal
AbdominalPPPPPPPPPP
Intraoperative (Specify)
Intraoperative
Neurological
PediatricPPPPPPPPPP
Small Organ (Specify)*
Neonatal CephalicPPPPPPPPPP
Adult CephalicPPPPPPPPPP
CardiacPPPPPPPPPPP
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;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

11

System Transducer X PLT-604AT_____________________________________________________________________________________________________________________________________________________________________ Model 510(k) Number(s)

1

Mode of Operation
Clinical ApplicationBTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI
Dynamic
FlowCombined
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric
Small Organ (Specify)*PPPPPPPP
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP
Laparoscopic
Musculo-skeletal
SuperficialPPPPPPPP
Musculo-skeletal
ConventionalPPPPPPPP

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)

,

(Division Sign-Off)

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 ApplicationBTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI
Dynamic
FlowCombined
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric
Small Organ (Specify)*PPPPPPPP
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP
Laparoscopic
Musculo-skeletal
SuperficialPPPPPPPP
Musculo-skeletal
ConventionalPPPPPPPP

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)

.. ...

(Division Sign-Off)

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 ApplicationBTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI
Dynamic
FlowCombined
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric
Small Organ (Specify)*PPPPPPPP
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP
Laparoscopic
Musculo-skeletal
SuperficialPPPPPPPP
Musculo-skeletal
ConventionalPPPPPPPP

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 ApplicationBTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI
Dynamic
FlowCombined
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric
Small Organ (Specify)*PPPPPPPP
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP
Laparoscopic
Musculo-skeletal
SuperficialPPPPPPPP
Musculo-skeletal
ConventionalPPPPPPPP

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 ApplicationBTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI
Dynamic
FlowCombined
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric
Small Organ (Specify)*PPPPPPPP
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP
Laparoscopic
Musculo-skeletal
SuperficialPPPPPPPP
Musculo-skeletal
ConventionalPPPPPPPP

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 ApplicationBTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI
Dynamic
FlowCombined
(Specify)
Ophthalmic
FetalPPPPPPPP
AbdominalPPPPPPPP
Intraoperative (Specify)
Intraoperative
Neurological
PediatricPPPPPPPP
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 (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)

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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
BTHI
MColor Doppler
PowerDynamic Flow
TDIPW
CWCHI 2D
CHI Dynamic FlowCombined (Specify)
Ophthalmic
FetalP
P
P
P
P
P
P
P
AbdominalP
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
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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 ApplicationBTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI
Dynamic
FlowCombined
(Specify)
Ophthalmic
FetalPPPPPPPP
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

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)

Aogui m Whz
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Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

19

Transducer X System PVT-770RT Model 510(k) Number(s)

Mode of Operation
Clinical ApplicationBTHIMColor DopplerPowerDynamic FlowTDIPWCWCHI 2DCHI Dynamic FlowCombined (Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
TransrectalPPPPPPPP
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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

20

System Transducer X PST-30BT Model 510(k) Number(s)

Mode of Operation
Clinical ApplicationBTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI
Dynamic
FlowCombined
(Specify)
Ophthalmic
Fetal
AbdominalPPPPPPPPPP
Intraoperative (Specify)
Intraoperative
Neurological
PediatricPPPPPPPPPP
Small Organ (Specify)*
Neonatal CephalicPPPPPPPPPP
Adult CephalicPPPPPPPPPP
CardiacPPPPPPPPPPP
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;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)

Aonald M. Weng

(Division Sign-Off Division of Reproductive, Abdominal an Radiological Devices 510(k) Number

21

and the comments of the comments of the comments of the comments of the comments of the comments of the contraction of the contribution of the contribution of the contributio

Transducer X System PST-50AT Model 510(k) Number(s)

Mode of Operation
Clinical ApplicationBTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI
Dynamic
FlowCombined
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
PediatricPPPPPPPP
Small Organ (Specify)*
Neonatal CephalicPPPPPPPP
Adult Cephalic
CardiacPPPPPPPP
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;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)

(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

22

Transducer X System PST-65AT Model 510(k) Number(s)

Mode of Operation
Clinical ApplicationBTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI
Dynamic
FlowCombined
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
PediatricPPPPPPPP
Small Organ (Specify)*
Neonatal CephalicPPPPPPPP
Adult Cephalic
CardiacPPPPPPPP
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;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)

(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

23

Transducer X System PLT-704SBT Model 510(k) Number(s)

ﻣﺘﺤﺪﺛ

Mode of Operation
Clinical ApplicationBTHIMColor DopplerPowerDynamic FlowTDIPWCWCHI 2DCHI Dynamic FlowCombined (Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric
Small Organ (Specify)*PPPPPPPP
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP
Laparoscopic
Musculo-skeletal
SuperficialPPPPPPPP
Musculo-skeletal
ConventionalPPPPPPPP

under Appendix E (L

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 Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

24

System_ Transducer _X Model

PLT-1204MV ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number(s)

: : ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Mode of Operation
Clinical ApplicationBTHIMColor DopplerPowerDynamic FlowTDIPWCWCHI 2DCHI Dynamic FlowCombined (Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric
Small Organ (Specify)*PPPPPPPP
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP
Laparoscopic
Musculo-skeletal
SuperficialPPPPPPPP
Musculo-skeletal
ConventionalPPPPPPPP

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 a Radiological Devices 510(k) Number

25

System Transducer X PVT-382MV_ Model 510(k) Number(s)

Mode of Operation
Clinical ApplicationBTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI
Dynamic
FlowCombined
(Specify)
Ophthalmic
FetalPPPPPPPP
AbdominalPPPPPPPP
Intraoperative (Specify)
Intraoperative
Neurological
PediatricPPPPPPPP
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Arzith Wrig
(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

26

System Transducer X PVT-681MV__ Model 510(k) Number(s)

Mode of Operation
BTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI
Dynamic
FlowCombined
(Specify)
Clinical Application
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
TransrectalPPPPPPPP
TransvaginalPPPPPPPP
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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Ayuu M. Why

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Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

27

Transducer _X System PET-511BTM Model ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number(s)

... ..........................................................................................................................................................................

Mode of Operation
Clinical ApplicationBTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI
Dynamic
FlowCombined
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac
TransesophagealPPPPPPPP
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/RWD; 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)

(Division Sign-Off)

Division of Reproductive, Abdomin Radiological Devices 510(k) Number

28

Transducer X

System _______________________________________________________________________________________________________________________________________________________________________ 510(k) Number(s)

Mode of Operation
Clinical ApplicationBTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI
Dynamic
FlowCombined
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
PediatricN
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
CardiacN
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularN
Laparoscopic
Musculo-skeletal
Superficial
Musculo-skeletal
Conventional

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Additional Comments:

)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Rogal Twth

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number