Predicate Devices

K933743, K943303, K963705, K964805, K970047, K981397

Reference Devices

K970047, K933743, K943303, K852159, K990490, K964865, K890969

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no information about training or test sets, performance metrics, or specific image processing techniques that would indicate AI/ML use.

Therapeutic

No
The device, an ultrasound system, is used for imaging and diagnostic purposes across various anatomical sites and patient age ranges, not for treating conditions.

Diagnostic

Yes
The device is an ultrasound system with indications for use across various anatomical sites and studies, which are typically used to diagnose medical conditions, making it a diagnostic device.

SaMD (Software as a Medical Device)

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.

IVD (In Vitro Diagnostic)

Based on the provided information, the Power Vision 8000 is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that the Power Vision 8000 is an ultrasound system used for imaging various parts of the human body directly (fetal, abdominal, cardiac, etc.). It does not involve the analysis of biological samples like blood, urine, or tissue.
The input imaging modality is ultrasonic. This is a non-invasive imaging technique applied externally or internally to the body, not a method for analyzing in vitro samples.

Therefore, the Power Vision 8000 falls under the category of medical imaging devices, not IVD devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Power Vision 8000 is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transesophageal, peripheral vascular, and musculo-skeletal (both conventional and superficial).

Product codes

90-IYN, 90-IYO, 90-ITX

Device Description

The PowerVision 8000 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 10 MHz.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic

Anatomical Site

Fetal, Abdominal, Intraoperative, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transesophageal, Peripheral Vascular, Musculo-skeletal (both conventional and superficial).

Indicated Patient Age Range

Neonatal, Pediatric, Adult

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)

K933743, K943303, K963705, K964805, K970047, K981397

Reference Device(s)

K970047, K933743, K943303, K852159, K990490, K964865, K890969

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

K991858

JUN 1 6 1999 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, Regulatory Affairs Specialist
Telephone No.:	(714) 730-5000

Device Proprietary Name: SSA-390A/PowerVision 8000 Ultrasound Imaging System Common Name:

Classification:

:

Regulatory Class:	II
Review Category:	Tier II

Ultrasonic Pulsed Doppler Imaging System - Procode: 90-IYN [Fed.Reg.No .: 892.1550] Ultrasonic Pulsed Echo Imaging System - Procode: 90-IYO [Fed.Reg.No .: 892.1560] Diagnostic Ultrasonic Transducer - Procode: 90-ITX [Fed. Reg. No .: 892.1570]

Identification of Predicate Devices:

Toshiba America Medical Systems believes that this device is substantially equivalent to the SSA-380A/PowerVision 7000, 510(k) control numbers K933743,K943303, K963705, K964805,K970047,K981397

Device Description:

The PowerVision 8000 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 10 MHz.

Intended Use:

The Power Vision 8000 is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, 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 (applicable portions), the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard. This unit is similar to that of the Toshiba SSA-380A/PowerVision 7000 and engineering assessments identify no new issues of risk or safety.

1

IIII

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 16 1999

Toshiba America Medical Systems, Inc. C/O Carole Stamp 510(k) Program Manager TUV Product Service 1775 Old Highway 8 New Brighton, MN 55112-1891

K991858 RE:

SSA-390A PowerVision 8000 Diagnostic Ultrasound System Dated: May 28, 1999 Received: June 21, 1999 Regulatory Class: II 21 CFR 892.1550/Procode: 90 IYN 21 CFR 892.1560/Procode: 90 IYO 21 CFR 892.1570/Procode: 90 ITX

Dear Ms. Stamp:

We have reviewed your Section 510(k) 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 also applies to the following transducers intended for use with the SSA-390A Power Vision 8000 Diagnostic Ultrasound System as described in your premarket notification:

Transducer Model Number(s):

PSN-20CT, PSN-37CT, PSN-25AT, PSN37AT, PSN-50AT, PSN-70AT, PLN-503AT, PLN-703AT, PLN-805AT, PVN-375AT, PVM-656AT, PVN-672AT, PC-19M, PLF-308P, PVF-738F, PVF-738H, PVF-745V, PVM-740RT, PEF-5190MB, PEK-510MB, PVN-661VT and PVN-760ST

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

2

Page -2 -- Ms. Carole Stamp

Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.

This determination of substantial equivalence is granted on the condition that prior to shipping of the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurement based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturer's Seeking Marketing Clearance of Diagnostic Ultrasound System and Transducers." If the special report is incomplete or contains unacceptable values, (e.g., not apply to the production units which is 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 as " 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entifled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

3

Page -3 - Ms. Carole Stamp

If you have any questions regarding the content of this letter, please contact Robert Phillips, Ph.D at (301) 594-1212.

Sincerely yours,

David li. dyarm

hn

CAPT Daniel Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

4

Diagnostic Ultrasound Indications For Use Form

Transducer____________________________________________________________________________________________________________________________________________________________________ System X Model SSA-390A 510(k) Number(s) __

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Harmonic
Imaging
Ophthalmic	n	n	n	n	n	n	n	n	n	n
Fetal	n	n	n	n	n	n	n	n	n	n
Abdominal	n	n	n	n	n	n	n	n	n	n
Intraoperative (Specify)	n	n	n	n	n	n	n	n	n	n
Intraoperative Neurological
Pediatric	n	n	n	n	n	n	n	n	n	n
Small Organ (Specify)	n	n	n	n	n	n	n	n	n
Neonatal Cephalic	n	n	n	n	n	n	n	n	n
Adult Cephalic	n	n	n	n	n	n	n	n	n
Cardiac	n	n	n	n	n	n	n	n	n	n
Transesophageal	n	n	n	n	n	n	n	n	n
Transrectal	n	n	n	n	n	n	n	n	n
Transvaginal	n	n	n	n	n	n	n	n	n
Transurethral
Intravascular
Peripheral Vascular	n	n	n	n	n	n	n	n	n
Laparoscopic
Musculo-skeletal Superficial	n	n	n	n	n	n	n	n	n
Musculo-skeletal	n	n	n	n	n	n	n	n	n
Conventional
Other (specify)

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

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

SEE DO NOT WRITE BELOW THIS LINE CONTINUE ON OTHER Concurrence of CDRH, Office of Device Evaluation

David A. Slegmm
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological I

510(k) Number Prescription Use (Per 21 CFR 801.109)

5

Transducer Model Number: PSN-20CT 510(k) Control Number: K970047

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (Specify)	Other (Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative Neurological
Pediatric
Small Organ (Specify)
Neonatal Cephalic		P	P	P	P	P	P	P	P
Adult Cephalic		P	P	P	P	P	P	P	P
Cardiac		P	P	P	P	P	P	P	P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal
Conventional
Other (specify)

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

NOTE: Original model number was PSK-20C

PLEASE DO NOT WRITTE BELOW THIS LINE-CONTINUE ON Concurrence of CDRH, Office of Device Eval

Vland A. Legrim

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

6

Transducer Model Number: PSN-37CT 510(k) Control Number: K933743

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Harmonic
Imaging
Ophthalmic
Fetal	E	E	E	E	E	E	E	E	E
Abdominal	E	E	E	E	E	E	E	E	E
Intraoperative (Specify)
Intraoperative Neurological
Pediatric	E	E	E	E	E	E	E	E	E
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	E	E	E	E	E	E	E	E	E
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal
Conventional
Other (specify)

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

NOTE: Original model number was PSK-37CT

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

David A. Lyman

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

7

Transducer Model Number: PSN-25AT 510(k) Control Number: K933743

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Harmonic
Imaging
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative Neurological
Pediatric		P	P	P	P	P	P	P	P	P
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P	P	P	P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal
Conventional
Other (specify)

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

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

NOTE: Original model number was PSK-25AT

Color Harmonic Imaging is applied to BDF & BDF/PWD Modes

Concurrence of CDRH, Office of Device Evaluation (ODE) 49451

David W. Ayres

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

8

Transducer Model Number: PSN-37AT 510(k) Control Number: K933743

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative Neurological
Pediatric		E	E	E	E	E	E	E	E
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	E	E	E	E	E	E	E	E	E
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal
Conventional
Other (specify)

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

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

NOTE: Original model number was PSK-37AT

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

Elvin A. Lyons
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Devi 510(k) Number .

9

Transducer Model Number: PSN-50AT 510(k) Control Number: K933743

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative Neurological
Pediatric		E	E	E	E	E	E	E	E
Small Organ (Specify)
Neonatal Cephalic		E	E	E	E	E	E	E	E
Adult Cephalic
Cardiac		E	E	E	E	E	E	E	E
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal
Conventional
Other (specify)

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

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

NOTE: Original model number was PSK-50AT

(PLEASE DO NOT WRITTS RELOW THIS LINE-CONTINUE ON OTHER PAGES IF NEFFICED Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seymour
(Division Sign-Off)

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

10

Transducer Model Number: PSN-70AT 510(k) Control Number: K933743

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative Neurological
Pediatric		E	E	E	E	E	E	E	E
Small Organ (Specify)
Neonatal Cephalic		E	E	E	E	E	E	E	E
Adult Cephalic
Cardiac		E	E	E	E	E	E	E	E
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal
Conventional
Other (specify)

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

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

NOTE: Original model number was PSK-70LT

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON OTHER Concurrence of CDRH, Office of Device Evaluation (C

David A. Lugann
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Dev

s10(k) Number K911834

11

Transducer Model Number: PLN-503AT 510(k) Control Number: K933743

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative Neurological
Pediatric
Small Organ (Specify)		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
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal		E	E	E		E	E	E	E
Conventional
Other (specify)

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

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

NOTE: Original model number was PLK-703AT

ISLE ASE DO NOT WAITE DELOW THIS LINE CONTINUE ON OTHER DAGES IS NEEDERS Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segerson

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

12

Transducer Model Number: PLN-703AT 510(k) Control Number: K933743

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
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		P	P	P		P	P	P	P
Conventional
Other (specify)

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

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

NOTE: Original model number was PLK-703AT

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

Elind M. Segura
(Division Sign-Off)

Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number J

13

Transducer Model Number: PLN-805AT 510(k) Control Number: K933743

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (Specify)	Other (Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative Neurological
Pediatric
Small Organ (Specify)		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
Laparoscopic
Musculo-skeletal Superficial		E	E	E		E	E	E	E
Musculo-skeletal		E	E	E		E	E	E	E
Conventional
Other (specify)

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

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

NOTE: Original model number was PLK-703AT

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

David G. Nygren
(Division Sign-Off)

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

14

Transducer Model Number: PVN-375AT

510(k) Control Number: K943303

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Harmonic
Imaging
Ophthalmic
Fetal		P	P	P		P	P	P	P	P
Abdominal		P	P	P		P	P	P	P	P
Intraoperative (Specify)
Intraoperative 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
Conventional
Other (specify)

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

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

NOTE: Original model number was PVK357AT

Color Harmonic Imaging is applied to BDF & BDF/PWD Modes

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ep

David Myers
(Division Sign-Off)

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

15

NEW TRANSDUCER TABLE

Transducer Model Number: PVM-656AT 510(k) Control Number:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal		N	N	N		N	N	N
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
Other (specify)

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

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

Concurrence of CDRH, Office of Device Evaluation

David L. Segura
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number .

16

NEW TRANSDUCER TABLE

Transducer Model Number: PVN-672AT 510(k) Control Number:

Clinical Application	B	M	PWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative Neurological
Pediatric	N	N	N	N	N	N	N
Small Organ (Specify)
Neonatal Cephalic	N	N	N	N	N	N	N
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal
Conventional
Other (specify)

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

SELL OW THE LINE CONTINUE ON OTHER D Concurrence of CDRH, Office of Device Evaluation (ODE)

Edward A. Ingram
(Division Sign Off)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Dev 510(k) Number .

17

Transducer Model Number: PC-19M 510(k) Control Number: K933473

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative Neurological
Pediatric					P
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac					P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal
Conventional
Other (specify)

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

Additional Comments:__________________________________________________________________________________________________________________________________________________________

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

David C. Ryane

(Division Sign-Off)

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

18

Transducer Model Number: PLF-308P 510(k) Control Number: K852159

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Harmonic
Imaging
Ophthalmic
Fetal
Abdominal		P	P	P		P	P	P	P
Intraoperative (Specify)		P	P	P		P	P	P	P
Intraoperative Neurological
Pediatric		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
Conventional
Other (specify)

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

NOTE: Original model number was GCE-406M

ALL ASE DO NOT WRITE BELOW THIS LINE CONTINUE ON OTHER PA Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Stigdonn
(Division Sign-Off)

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

19

Transducer Model Number: PVF-738F 510(k) Control Number: K990490

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal		P	P	P		P	P	P	P
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
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal
Conventional
Other (specify)

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

NOTE: Original model number was IOE-703F (K852159)

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

(Division Sign-Off)

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

20

Transducer Model Number: PVF-738H

510(k) Control Number: K990490

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal		P	P	P		P	P	P	P
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
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal
Conventional
Other (specify)

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

NOTE: Original model number was IOE-703H (K852159)

4PLEASE DO NOT WRITTS BELOW THIS LINE-CONTINUE ON OTHER PAGES IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

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

21

Transducer Model Number: PVF-745V 510(k) Control Number: K990490

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal		P	P	P		P	P	P	P
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
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal
Conventional
Other (specify)

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

NOTE: Original model number was IOE-703F (K852159)

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

Ehmil G. Stymm
(Division Sign-Off)

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

22

EXISTING TRANSDUCER TABLE Transducer Model Number: PVM-740RT 510(k) Control Number: K964865

			Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative Neurological
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P	P		P	P	P	P
Transvaginal		P	P	P		P	P	P	P
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal
Conventional
Other (specify)

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

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

NOTE: Original model number was PVK-720ST (K964865)

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

Elinil C. Sypm
(Division Sign-Off)

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

23

EXISTING TRANSDUCER TABLE Transducer Model Number: PEF-510MB 510(k) Control Number: K964865

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(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
Other (specify)

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

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

NOTE: Original model number was PEF-511SA (K890969)

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

David L. Ingram
(Division Sign-Off)

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

24

Transducer Model Number: PEK-510MB 510(k) Control Number: K964865

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(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
Other (specify)

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

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

NOTE: Original model number was PEF-511SA (K890969)

(PLEASE DO NOT WRITTS BELOW THIS LINE CONTINUE ON OTHER PAC IF NEFFED Concurrence of CDRH, Office of Device Evaluation (ODE)

Ehristi Lynn

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

25

NEW TRANSDUCER TABLE

Transducer Model Number: PVN-661VT 510(k) Control Number:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		N	N	N		N	N	N	N
Abdominal
Intraoperative (Specify)
Intraoperative Neurological
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N		N	N	N	N
Transvaginal		N	N	N		N	N	N	N
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal
Conventional
Other (specify)

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

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON OTH Concurrence of CDRH, Office of Device Evaluation

Elinh. Seym

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

26

Transducer Model Number: PVN-760ST 510(k) Control Number: K964865

Mode of Operation CWD Amplitude Color Combined PWD Color Harmonic B M A Clinical Application Doppler Velocity (Specify) Doppler Imaging Imaging Ophthalmic Fetal Abdominal Intraoperative (Specify) Intraoperative Neurological Pediatric Small Organ (Specify) Neonatal Cephalic Adult Cephalic Cardiac Transesophageal Transrectal P P P P P P Р P P P P P P P Transvaginal Transurethral Intravascular Peripheral Vascular Laparoscopic Musculo-skeletal Superficial Musculo-skeletal Conventional Other (specify)

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

NOTE: Original model number was PVK-760ST

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

Ehrid A. Syrm
(Division Sign-Off)

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