SSA-320A JUST VISION 200/ SSA-325A JUST VISION by TOSHIBA AMERICA MEDICAL SYSTEMS, INC.

The JustVision is intended to be used for the following type of studies; fetal organ, abdominal, pediatric, small organs, neonatal cephalic, cardiac, transrectal, transvaginal, peripheral vascular, and musculo-skeletal (both conventional and superficial).

Device Description

The JustVision Ultrasound System is available as a compact portable system or can be configured as a mobile system with a 12 inch monitor. This system is a Track 1 device that employs a wide array of probes that include flat linear array and convex linear array, with a frequency range of approximately 2 MHz to 10 MHz.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Toshiba JustVision Ultrasound System:

Summary of Device and Evidence:

The Toshiba JustVision 200 and JustVision 400 are Ultrasound Imaging Systems. The application focuses on demonstrating substantial equivalence to a predicate device (SSA-220A Capasee, K933747) and expanding the indications for use for various transducers. The "study" here is primarily a substantial equivalence comparison and declaration of compliance with relevant standards, rather than a clinical trial in the traditional sense for a new diagnostic accuracy claim.

1. Table of Acceptance Criteria and Reported Device Performance

Instead of traditional quantitative acceptance criteria (e.g., sensitivity, specificity), the approval documentation for the Toshiba JustVision Ultrasound System and its transducers relies on substantial equivalence to a predicate device and adherence to recognized safety standards. The "performance" is implicitly deemed equivalent if these conditions are met.

Acceptance Criterion (Implicit)	Reported Device Performance/Evidence
Substantial Equivalence to Predicate Device	The device (JustVision 200/400) is "substantially equivalent to the SSA-220A Capasee, 510(k) control number K933747."
Safety and Effectiveness Assessment (via Standards Compliance)	"This device is designed and manufactured in conjunction with the Quality System Regulation, ISO-60601 (applicable portions) and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 1 Ultrasound systems. This unit is similar to that of the Toshiba SSA-220A Capasee and engineering assessments identify no new issues of risk or safety." The FDA grants clearance "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... "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..."
Equivalent Intended Use/Clinical Indications	The document extensively lists various clinical applications for the system and each transducer. For many transducers, indications are marked "P" (Previously Cleared by FDA) indicating they match the predicate device's cleared indications. For some indications, they are marked "N" (New Indication), suggesting these were assessed as equivalent despite being new to that specific transducer.

2. Sample Size for the Test Set and Data Provenance

The provided text does not describe a specific clinical test set with patient data or a sample size in the context of diagnostic accuracy for this 510(k) submission. The "study" is primarily an engineering and regulatory assessment comparing the new device to a predicate. The compliance is based on:

Engineering assessments (comparison of design, specifications, and safety features to the predicate).
Adherence to recognized industry standards (ISO-60601, AIUM-NEMA UD2 for acoustic output).
A post-clearance report requiring acoustic output measurements from production units.

Therefore, there is no "test set" in the traditional sense of a patient cohort, nor is there information about data provenance (country of origin, retrospective/prospective).

3. Number of Experts and Qualifications for Ground Truth

No experts were used to establish ground truth for a diagnostic performance test set, as no such test set is described or required for this type of substantial equivalence submission. The "ground truth" here is compliance with safety standards and functional equivalence to the predicate device, which is assessed through engineering analysis and regulatory review.

4. Adjudication Method for the Test Set

Not applicable as there is no diagnostic test set requiring human expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done or is mentioned. The submission is not for an AI-assisted device in the context of improving human reader performance. It's for an ultrasound imaging system.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This device is an ultrasound imaging system, not an algorithm, and the submission is not focused on an AI algorithm's standalone performance.

7. Type of Ground Truth Used

The "ground truth" for this submission is established through:

Predicate Device Equivalence: The gold standard is the legally marketed predicate device (SSA-220A Capasee, K933747) and its established safety and effectiveness.
Engineering Standards Compliance: Adherence to recognized national and international safety and performance standards for ultrasound devices (Quality System Regulation, ISO-60601, AIUM-NEMA UD2).
Acoustic Output Measurements: Post-clearance measurements of acoustic output from production line devices to ensure they fall within approved levels.

8. Sample Size for the Training Set

Not applicable. This is not a submission for a machine learning or AI-driven device that requires a training set. The device is a traditional ultrasound imaging system.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device submission.

Summary

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3/2/99

q90490

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

Submitter's Name:	Toshiba America Medical Systems, Inc.
Address:	P.O. Box 2068,2441 Michelle Drive Tustin, CA 92781-2068
Contact:	Paul Biggins, Regulatory Affairs Specialist
Telephone No.:	(714) 730-5000

Just Vision 200 and Just Vision 400 Device Proprietary Name: Common Name: Ultrasound Imaging System

Classification:

Regulatory Class: II Review Category: Tier II Ultrasonic Pulsed Echo Imaging System [Fed.Reg.No .: 892.1560,Pro.Code:90-IYO]

Identification of Predicate Devices:

Toshiba America Medical Systems believes that this device is substantially equivalent to the SSA-220A Capasee, 510(k) control number K933747

Device Description:

Intended Use:

Safety Considerations:

This device is designed and manufactured in conjunction with the Quality System Regulation, ISO- 60601 (applicable portions) and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 1 Ultrasound systems. This unit is similar to that of the Toshiba SSA-220A Capasee and engineering assessments identify no new issues of risk or safety.

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

Image /page/1/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an emblem that features three stylized human figures, possibly representing people, in a flowing, abstract design.

MAR - 2 1999

Toshiba America Medical Systems, Inc. C/o Carole Stamp TUV Product Service 1775 Old Highway 8 NW, Suite 104 New Brighton, MN 55112-1891

K990490 Re: SSA-320A JustVision 200 and SSA-325A JustVision 400 Regulatory Class: II/ 21 CFR 892.1560/21 CFR 892.1570 Product Code: 90 IYO/ 90 ITX Dated: February 11, 1999 Received: February 16, 1999

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 applies to the following transducers intended for use with the SSA-320A JustVision 200 and SSA-325A JustVision 400, as described in your premarket notification:

Transducer Model Number PVG-366M PVG-381M PVG-681S PVG-600S PVG-601V PVG-720S PVG-738F PVF-738H PVF-745V PLG-308P PLG-506M

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 (OS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic OS 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}------------------------------------------------

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. 1. 1. 1. 1. 1. 18. 1. 18. 1. 1. 1. 1. 1. 1. 1. 1.

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 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 entitled, "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".

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

Sincerely vours.

Kamil A. Seymann

CAPT Daniel G. 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

Enclosures

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Transducer_ System X_ Model____SSA -320A/SSA-325A_ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number(s) _____________________________________________________________________________________________________________________________________________________________

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		n	n						n
Abdominal		n	n						n
Intraoperative (Specify)		n	n						n
Intraoperative Neurological
Pediatric		n	n						n
Small Organ (Specify)		n	n						n
Neonatal Cephalic		n	n						n
Adult Cephalic
Cardiac		n	n						n
Transesophageal
Transrectal		n	n						n
Transvaginal		n	n						n
Transurethral
Intravascular
Peripheral Vascular		n	n						n
Laparoscopic
Musculo-skeletal Superficial		n	n						n
Musculo-skeletalConventional		n	n						n
Other (specify)

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

Additional Comments: _________________________________________________________________________________________________________________________________________________________

and the comments of the comments of the comments of the comments of the comments of ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER CCC IS NEDDED --Concyfrence of CDRH, Office of Device Evaluation (ODE)

David A. Segner
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Device

Radiological Devices
510(k) Number K990490

{4}------------------------------------------------

Transducer_x__ System PVG-366M Model_ 510(k) Number(s) _

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P						P
Abdominal		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
Other (specify)

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

Additional Comments: Combined mode is B+M

Note: This transducer was originally cleared with the SSA-220A via 510(k) control number K933747

Concerrence of CDRH. Office of Device Evaluatio

David G. Severson

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

Prescription Use (Per 21 CFR 801.109)

{5}------------------------------------------------

Transducer_x System ___ PVG-381M_ Model 510(k) Number(s) _

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P						P
Abdominal		P	P						P
Intraoperative (Specify)
Intraoperative Neurological
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		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 mode is B+M

Note: This transducer was originally cleared with the SSA-220A via 510(k) control number K933747

Concurrence of CDRH. Office of Device Evalua

David A. Syzmon

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

{6}------------------------------------------------

Transducer_X System _ Model_ PVG-681S_ 510(k) Number(s) __

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal		N	N						N
Intraoperative (Specify)
Intraoperative Neurological
Pediatric
Small Organ (Specify)
Neonatal Cephalic		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 mode is B+M

Device Evaluat

Uhmil A. Syonn
(Division Sign-Off)

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

Prescription Use (Per 21 CFR 801.109)

{7}------------------------------------------------

System _ Transducer_X__ PVG-600S Model

510(k) Number(s) __

			Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative Neurological
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N						N
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 mode is B+M

Note: This transducer was originally cleared with the SSA-140A via 510(k) control number

K913798

Concurrence of CDRH. Office of Device Evaluatio

David A. Seznor
(Division Sign Off)

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Dev

510(k) Number K140440

{8}------------------------------------------------

Transducer_X_ System _ PVG-601V Model 510(k) Number(s) _

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P						P
Abdominal
Intraoperative (Specify)
Intraoperative Neurological
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal		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)

Additional Comments: Combined mode is B+M

Note: This transducer was originally cleared with the SSA-220A via 510(k) control number K933747

4PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON OTHER PA Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Tegner

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

{9}------------------------------------------------

System _ Transducer_X_ -PVG-720S Model_ 510(k) Number(s) _

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

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

Additional Comments: Combined mode is B+M

Note: This transducer was originally cleared with the SSA-220A via 510(k) control number

K933747

Concurrence of CDRH, Office of Device Evaluatio

David G. Segner

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

{10}------------------------------------------------

Transducer_X System PVF-738F Model ______________________________________________________________________________________________________________________________________________________________________________ 510(k) Number(s) _____________________________________________________________________________________________________________________________________________________________

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

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

Additional Comments: Combined mode is B+M

Note: This transducer was originally cleared as probe IOE-703F with the SSA-90A via 510(k) control number K852159

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

Concurrence of CDRH, Office of Device Evaluation (C

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K990490

Prescription Use (Per 21 CFR 801.109)

{11}------------------------------------------------

System __ Transducer_X_ PVF-738H_ Model ______________________________________________________________________________________________________________________________________________________________________________

510(k) Number(s) __

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

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

Additional Comments: Combined mode is B+M

Note: This transducer was originally cleared as probe IOE-703H with the SSA-90A via 510(k) control number K852159

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

Clint G. Seppam

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Devic

510(k) Number K992446

{12}------------------------------------------------

System __ __ Transducer_X_ Model_ PVF-745V 510(k) Number(s) _

	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
Intraoperative (Specify)		P	P						P
Intraoperative Neurological
Pediatric
Small Organ (Specify)		P	P						P
Neonatal Cephalic		N	N						N
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P						P
Laparoscopic
Musculo-skeletal Superficial		N	N						N
Musculo-skeletal		N	N						N
Conventional
Other (specify)

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

Additional Comments: Combined mode is B+M

Note: This transducer was originally cleared as probe IOE-703F with the SSA-90A via 510(k) control number K852159

Concurrence of CDR

David G. Segner
(Division Sign-Off)

Division of Reproductive, Abdominal, EN and Radiological Devi

510(k) Number K990445

{13}------------------------------------------------

Transducer_X_ System _ Model_ PLG-308P 510(k) Number(s) _

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal		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
Other (specify)

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

Additional Comments: Combined mode is B+M

Note: This transducer was originally cleared as probe GCE-406M With the SSA-90A via 510(k)

control number	K852159
----------------	---------

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

David A. Sezmann

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K990440

{14}------------------------------------------------

Transducer_X_ System _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ PLG-506M Model_ 510(k) Number(s) _

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

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

Additional Comments: Combined mode is B+M

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

David G. Segerson

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

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.