LogoFDA 510(k) Search
K Number
K082119
Device Name
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0
Manufacturer
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
Date Cleared
2008-08-12

(15 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 types 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

K081065, K063518

Not Found

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

No
The device is described as an "Ultrasound System" intended for "studies" and diagnostic imaging, not for treating conditions.

Yes

The device description mentions it is an "Ultrasound System," and the predicate devices listed are "Diagnostic Ultrasound." The "Intended Use" section also lists various medical studies performed to aid in diagnosis.

No

The device description explicitly states it is a "mobile system" and employs "a wide array of probes," indicating the presence of hardware components beyond just software.

Based on the provided information, the Aplio XG Ultrasound System is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue). The Aplio XG is an ultrasound system that uses sound waves to create images of internal body structures in vivo (within the living body).
  • The intended use and anatomical sites listed are all related to imaging internal body parts directly. There is no mention of analyzing samples or specimens.
  • The device description clearly states it's an ultrasound system. Ultrasound is an imaging modality, not an IVD method.

Therefore, the Aplio XG is a medical imaging device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Aplio XG is intended to be used for the following types 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 (comma separated list FDA assigned to the subject device)

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

Ultrasound

Anatomical Site

Not Found

Indicated Patient Age Range

Fetal, Pediatric, Neonatal (Cephalic), Adult (Cephalic)

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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K081065, K063518

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

510(k) Summary of Safety and Effectiveness: 21 CFR 807.92 1. And 1

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 3.0 Common Name: Diagnostic Ultrasound System

:

AUG 1 2 2008

Classification:

Regulatory Class: II Review Category: Tier II

  • Ultrasonic Pulsed Doppler Imaging System Product Code: 90-IYN [Fed. Reg. No.: . 892.15501
  • 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 2.2 Diagnostic Ultrasound; 510(k) K081065
    1. Hitachi Medical Systems America Inc. HI VISION 900 Diagnostic Ultrasound Scanner 510(k) K063518

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 types 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three human figures underneath. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 9-2008

Toshiba America Medical Systems. Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K082119

Trade/Device Name: Aplio XG v3.0 SSA-790A Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 26, 2008 Received: July 28, 2008

Dear Mr. Job:

This letter corrects our substantially equivalent letter of August 12, 2008.

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 v3.0 SSA-790A, as described in your premarket notification:

Transducer Model Number

PVT-375BTPET-510MB
PVT-661VTPST-25BT
PLT-1202SPLT-604AT
PC-20MPLT-704AT

2

PLT-805ATPLT-1204MV
PLT-1204ATPVT-382MV
PLT-1204AXPVT-681MV
PVT-382BTPET-511BTM
PVT-674BTPC-50M
PVT-575MVPLT-705BTF
PVT-770RTPLT-705BTH
PST-30BTPLT-1204BT
PST-50ATPLT-1204BX
PST-65ATPVT-745BTV
PLT-704SBT

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

3

Page 2 - Mr. Job

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,

Logu Mkhang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

4

Diagnostic Ultrasound Indic Thous For Use Form

System Transducer

Model & PVT-575MVAN Comments www.manage.com a

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 K081065

(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)

Evaluation (ODE)

Hebert Lewin

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

መጨረሻ መጨረሻ የሚያስተዋል። መልክ አይነት የመጣለት የሚያስተዋል። በማምጣት ነው። የ

5

Diagnostic Ultrasound Indications For

Transducer

Model PVT-770RT

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 K081065

(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)

Hulutten
Division Sign-Off

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

6

Diagnostic Ultrasound Indications For Use Forn

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Transducer X Model + PST-30BT =============================================================================================================================================================

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)

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; FEVBDF

Previous S10{k) for this device K081065

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

Prescription Use (Per 21 CFR 801.109)

(Division Sidn-Off Division of Reproductive, Abdominal and Radiological Devi 510(k) Number

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System PST-50AT --------------------------------------------------------------------------------------------------------------------------------------------------------------

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;

(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 Sigh-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082119

8

. Diagnostic Ultrasound Indications For Use Form .

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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)

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; FEVBDF

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

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082119

9

iagnostic Ultrasound Indications Tor I

ransducer

Model -- PLT-704SBT

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)

Combined Modes: B/M; B/PWD; Additional Comments: 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)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082119

10

. Diagnosne Ultrasound Indications For Use Edrin

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e - - - - - - - - - - - - - - - - - - - - -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)*PPPPPPPPP
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethra!
Intravascular
Peripheral VascularPPPPPPPPP
Laparoscopic
Musculo-skeletal
SuperficialPPPPPPPPP
Musculo-skeletal
ConventionalPPPPPPPPP

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 K081065

(PLEASE DO NOT WRITE BEL

SE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)
---------------------

Prescription Use (Per 21 CFR 801.109)

(Uivision Sign-Off) Division of Reproductive, Abdominal and Radiological Devices K682119 510(k) Number ________________________________________________________________________________________________________________________________________________________________

11

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Transducer stem Model -- PVT-382MV ---------------------------------------------------------------------------------------------------

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)

Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD

Previous 510(k) for this device K0810650

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NE 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

Diagnostic Ultrasound Indications For Use Form .

Model PVT-681MV

ransdi

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 K081065

(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

Diagnostic Ultrasound Indications Cor Use Form

System -----------------------------------------------------------------------------------------------------------------------------------------------------------------------", " . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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)

Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD;

(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) Number15082119

14

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System "Tra

Model PC-50M

510(k) Number(s)

  • 33-
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 K081065

(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 ા તા 510(k) Number ________________________________________________________________________________________________________________________________________________________________

15

Diagnostic Ultrasound Indications For Use Form

Transducer X System PLT-705BTF Model 510(k) Number(s)

Mode of Operation
Clinical ApplicationBTHIMColor DopplerPowerDynamic FlowTDIPWCWCHI 2DCHI Dynamic FlowCombined (Specify)
Ophthalmic
Fetal
AbdominalNNNNNNNN
Intraoperative (Specify)NNNNNNNN
Intraoperative
Neurological
Pediatric
Small Organ (Specify)*NNNNNNNN
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

(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 K082119

16

Diagnostic Ultrasound Indications For Use Form

Transducer _X System _ PLT-705BTH Model 510(k) Number(s)

Clinical ApplicationBTHIMColor DopplerPowerDynamic FlowTDIPWCWCHI 2DCHI Dynamic FlowCombined (Specify)
Ophthalmic
Fetal
AbdominalNNNNNNNN
Intraoperative (Specify)NNNNNNNN
Intraoperative
Neurological
Pediatric
Small Organ (Specify)*NNNNNNNN
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:
BDF/PWD; BDF/MDF; BDF/MDF/PWD
Combined Modes: B/M; B/PWD;Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082119

17

iagnostic Ultrasound Indications For Use Form

ות מאי

State State of the markets of the state and the

. . P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

12:27:54

ransducer X min - 1 1 % to em 204B 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)*NNNNNNNNNNNN
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNNNNNNNN
Laparoscopic
Musculo-skeletal
SuperficialNNNNNNNNNNNN
Musculo-skeletal
ConventionalNNNNNNNNNNNN

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (QD) (Division Sign-Off) Prescription Use (Per 21 CFR 801.109) Division of Reproductive, Abdomina

Radiological Devices 510(k) Number

18

Diagnostic Ultrasound Indications For Use Form

System X Transducer Aplio XG v3.0 SSA-790A_ Model 510(k) Number(s)

Carlos Concession Consideration of Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Chil

Mode of Operation
Clinical ApplicationBTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI
Dynamic
FlowCombined
(Specify)
Ophthalmic
FetalPPPPPPPP
AbdominalPPPPPPPPP
Intraoperative (Specify)PPPPPPP
Intraoperative
Neurological
PediatricPPPPPPPPPP
Small Organ (Specify)*PPPPPNNPP
Neonatal CephalicPPPPPPPPP
Adult CephalicPPPPPPPPP
CardiacPPPPPPPPPPP
TransesophagealPPPPPPPP
TransrectalPPPPPPPP
TransvaginalPPPPPPPP
Transurethral
Intravascular
Peripheral VascularPPPPPNNPPP
Laparoscopic
Musculo-skeletal
SuperficialPPPPPNNPP
Musculo-skeletal
ConventionalPPPPPNNPP

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/MDE: BDF/MDE/PWD:B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D: FEI/2D: CHI/BDF: FEVBDF

All indications were previously reported via K081065

  • : 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

lu

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 12082114 510(k) Number

A-4

19

े में में में में में मिले में में प्रशासन में मिल सुरुवा बाद मिल रहे हैं कि र
िक में बाद में बाद में ही गुजावन में किसी में प्रकार किया था। बाह प्रकार किस स
े बाद में बाद म

ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ

నిరా

Transduce 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 K081065

(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)

.

Helson

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

20

iagnosita l'Ion Folind Indica TOTIC

1954

.. ﺔ ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ

Model PVT-66IVT

Model 1-FOOT V
5100's Number(s)

510(k) Number(s)

发

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 K081065

(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 4082119 510(k) Number _

21

. Co., Diagnostic Ultrasound Infolla (mir ann ann an Sans

Start of Transducer Sos

PLT-1202S Model

510(k) Number(s)

and the comments of the comments of the comments of the comments of the comments of the first of the first of the first of the first of the first of the first of the first of

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

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

Previous 510(k) for this device K081065

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

Prescription Use (Per 21 CFR 801.109)

Helena Sommer

(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices 11-08211 510(k) Number -

22

nostic 1014, com of the more of

ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ

nsdi Model PC-20M

510(k) Number(s)

1 4 4 4 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

1.17.20

Mode of Operation
Clinical Application8THIMColor
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 K081065

(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)

Vell Lence

(Division Sign-Off)

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

23

Diagnostacaging and the China China (Italia ya Post
a

الموالي الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع المو

2:21 80.000

ינק יוני עינו

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 K081065

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

Prescription Use (Per 21 CFR 801.109)

Haddad Limmen

... ... ... ..

2.01.6222

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 1082119 510(k) Number

24

में स्वास्थ्य में स्वागति में प्रतीय साल में कि महिला है। शुरू किया

ાં ડાંગ

1991 11:49

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Fransduce Model_PST-25BT

510(k) Number(s)

,一

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

Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TD1; 2D/CWD; BDF/CWD; CHI/2D; FEV2D; CHI/BDF; FEI/BDF; FEI/BDF

Previous 510(k) for this device K081065

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

Prescription Use (Per 21 CFR 801.109)

Hh. Rem

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices K082119 510(k) Number __

25

Diagnostica di tra Komita bitlio Tihak di majin (li

1999 - 1999

人的 ાં

A .. Both Combines St.

ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ

Transducer X and

રિક ન

PLT-604AT 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 K081065

(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 Sign-Off) Division of Reproductive, Abdominal and Radiological Devices NO82119 510(k) Number _

26

وال سال المقال بين صورت الوالي الصحي الروالي الصحي التي في ال

: 上一篇:

1003 1295

19:12:43 19:54

ansducer and the ,在此

Model PLT-704AT --------------------------------------------------------------------------------------------------------------------------------------------------------------

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-skeletalPPPPPPPP
Superficial
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 K081065

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

Prescription Use (Per 21 CFR 801.109)

signature

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

27

. PD lagnostical in provincia maile dipus provinsi Porm .

11 21 21

ಿಗೆ ಮ ાં છે. આ ગ ત જેવાયું I ransduce ਤੇ ਸਿੰਘ ਸੀ। ਉਹ

.. 1.15

Model PL L-805AT - 805AT 11 - 1944 12 2017 11:54 ్రాలు . የራ 510(k) Number(s)

an and the se

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: _________________________________________________________________________________________________________________________________________________________ BDF/PWD; BDF/MDF; BDF/MDF/PWD

Previous 510(k) for this device K081065

(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 _

28

A plagnosticounts connabhalty affacy formic fivilian

177

aller & States of the County of Court of Courself

T and Architers Transducer ystem

  • Model -- PLT-1204AT
    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 K081065

(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)

Evaluation (SDE)

(Division Sign-Off)

Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082119

29

্রামের মাধ্যমে মানুষ মানুষ মানুষ মানুষ প্রতিষ্ঠান করে বিশ্বকাপে পারে।

প্রতিষ্ঠান
প্রকল্পিত বিশ্বকাপ ្រ

173 - 1 1997 ਰ ਦੇ ਜਾਂ ਨਾਲ ਅੰਮ 1 2017 el PET 204AX -it de la versioner in die voor de voor het het het het het health het het health het het health het het health het health and het health and held hand the been and the been a

510(k) Number(s)

.

4 35 44

Mode of Operation
Clinical ApplicationBTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI
Dynamic
FlowCombined
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric
Small Organ (Specify)*PPPPPPPPP
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)

Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD

Previous 510(k) for this device K081065

(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)

Helentame

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

30

ហាន់​ខ្លាំង​ទៅ​របស់​ក្រុង​ព្រៃ​ជា​ជា​គ្រប់​ទេ មាន​ក្រុម​នោះ​ នេះ​ក្រោះ​ អនុ​រ 的

13 - 201

2.5 (2) 2

System - - - Transducer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Model : PVT-382BT

510(k) Number(s)

Mode of Operation
Clinical ApplicationBTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI
Dynamic
FlowCombined
(Specify)
Ophthalmic
FetalPPPP .PPPP
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 K081065

(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)

e Evaluation (ODE)

(Division Sign-Off)

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

31

of makins 1 the coom Tricks (got Cara, 1981 Bojana -

:

Transducet &

Model PVT-674BT-- States of the

510(k) Number(s)

Mode of Operation
Clinical ApplicationBTHIMColorDopplerPowerDynamicFlowTDIPWCWCHI2DCHIDynamicFlowCombined(Specify)
OphthalmicP
FetalPPPPPPPP
AbdominalPPPPPPPP
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)

Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD

Previous 510(k) for this device K081065

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

Prescription Use (Per 21 CFR 801.109)

luation (ODE)

(Division Sign-Off)

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

A-17

32

े में भी में मुक्त पूर्व स्वास् र करानी शिक्षा मिलान रिकास रिकास है कि म

िली के मुख्यमंत्री में स्वास्त्री के लिए सितंबर बिहार स्टेशन के बाद हो गया
। अ

:

* System - Transdueds X - Transducer - Same - System

Model PLT-1204BX Model > PLT-1204BX > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > >

:

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

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

(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)

Helin Sume

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082119

33

ে প্রকাশন ও পরিবার প্রধানমন্ত্রী করে না করে বাস্তার করে বাস্তারী ও

,在一起的 . System Ministration of the mail of the state of the mail of the comments of the comments of the comments of the counter

S i 0(x) Number(s)

Mode of Operation
Clinical ApplicationBTHIMColor
DopplerPowerDynamic
FlowTDIPWCWCHI
2DCHI
Dynamic
FlowCombined
(Specify)
Ophthalmic
Fetal
AbdominalNNNNNNNN
Intraoperative (Specify)NNNNNNNN
Intraoperative
Neurological
Pediatric
Small Organ (Specify)*NNNNNNNN
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;

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

Prescription Use (Per 21 CFR 801.109)

:

Helstema
(Division Sign-Off)

:

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