Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No
The device description and intended use indicate it is an ultrasound system used for imaging and diagnostic purposes across various anatomical sites, not for treating conditions.

Diagnostic

Yes
The device is an ultrasound system intended for various medical studies, which are typically performed to diagnose conditions or assess health status.

SaMD (Software as a Medical Device)

No

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

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use describes the device as being used for various types of ultrasound studies on different anatomical sites and patient populations. This is a description of a diagnostic imaging device used for visualizing internal structures, not for examining specimens derived from the human body (like blood, urine, or tissue samples) outside of the body.
Device Description: The description confirms it's an Ultrasound System, which is a medical imaging modality.
Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any processes typically associated with in vitro diagnostics.

In vitro diagnostics are tests performed on samples taken from the human body to detect diseases, conditions, or infections. This device is used for non-invasive imaging of the body itself.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

90-IYN, 90-IYO, 90-ITX

Device Description

The APLIO 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

Not Found

Anatomical Site

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

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

Not Found

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

Not Found

Predicate Device(s)

K992886, K013633

Reference Device(s)

Not Found

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

AUG 0 6 2002

Kozzyoo

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:	Michaela Mahl, Regulatory Affairs Specialist
Telephone No .:	(714) 730-5000

Device Proprietary Name:	SSA-700A, APLIO
Common Name:	Diagnostic Ultrasound System

Classification:

Regulatory Class:	II
Review Category:	Tier II

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

Identification of Predicate Devices:

Toshiba America Medical Systems believes that this device is substantially equivalent to the UIDM-400A, 510(k) control number K992886 and SSA-770A APLIO, control number K013633.

Device Description:

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

Safety Considerations:

This device is designed and manufactured in conjunction with the Quality System Regulation, IEC 60601 (applicable portions), IEC60601-2-37 (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 same to that of the Toshiba SSA-770A Aplio cleared and engineering assessments identify no unmitigated issues of risk or safety.

1

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting hair or movement. The profiles are stacked one behind the other, creating a sense of depth.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Toshiba America Medical Systems, Inc. % Mr. Mark Job Program Manager TÜV Product Services, Inc. 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891

Re: K022400

Trade Name: SSA-700A, APLIO Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: July 22, 2002 Received: July 23, 2002

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

AUG 0 6 2002

This determination of substantial equivalence applies to the following transducers intended for use with the SSA-700A, APLIO Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

PST-20CT
------------------------
PST-25AT
---------
PVT-375AT
---------
PVT-661VT

2

Image /page/2/Picture/1 description: The image shows a list of product codes. The product codes are PLT-805AT, PLT-1202S, PLT-1204AX, PET-704LA, and PC-20M. Each product code is underlined.

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.

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

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 (OS) 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 letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at (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

3

Page 3 – Mr. Job

notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

David A. Hyrum
for Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

4

KO22400

Diagnostic Ultrasound Indications For Use Form

System X Transducer_

Model SSA-700A

510(k) Number(s)

K022400

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

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

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

BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD;

CHI/2D; FEI/2D; CHI/BDF; FEI/BDF; FEI/BDF

Abdominal **

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)

David A. Seymon

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

5

Transducer Model Number: PST-20CT

510(k) Control Number: KO13633-

·

	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
Small Organ (Specify)
Neonatal Cephalic		P	P	P	P	P	P	P	P	P	P
Adult Cephalic		P	P	P	P	P	P	P	P	P	P
Cardiac		P	P	P	P	P	P	P	P	P	P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal
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; 2D/CWD; BDF/CWD;

CHI/2D; FEI/2D; CHI/BDF; FEI/BDF

( 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 A-5 510(k) Number _

6

Transducer Model Number: PST-25AT

. .

510(k) Control Number: K013633

		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; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D: FEI/2D; CHI/BDF; FEI/BDF; FEI/BDF = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =

( 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)

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

David A. Seggern
(Division Sign Off)

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

7

Transducer Model Number: PVT-375AT

510(k) Control Number: Korsoss

| 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; Additional Comments:

BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; CHI/2D;

FEI/2D; CHI/BDF; FEI/BDF______________________________________________________________________________________________________________________________________________________

( 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)

David A. Digum
(Division Sign-Off)

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

8

Transducer Model Number: PVT-661VT

510(k) Control Number: Katséss

	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	P
Transvaginal		P	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)

Additional Comments:_____ Combined ___________ B/M; ____ B/PWD; ____ B/PWD; BDF/MDF;BDF/MDF/PED; B-TDI; M-TDI

( 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)

David A. Lipson

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 027400 510(k) Number ________________________________________________________________________________________________________________________________________________________________

9

Transducer Model Number: PLT-805AT

510(k) Control Number: K013633

		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
Small Organ (Specify)***		P	P	P		P	P	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P	P		P	P	P	P	P
Laparoscopic
Musculo-skeletal
Superficial		P	P	P		P	P	P	P	P
Musculo-skeletal
Conventional		P	P	P		P	P	P	P	P
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; CHI/2D;

FEV2D; CHI/BDF; FEI/BDF

For example: thyroid, parathyroid, breast, scrotum and penis ***

David hi. Lipson
(P
Conc

( 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 K022400

10

Transducer Model Number: PLT-1202S

510(k) Control Number: K043693

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

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

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

Abdominal

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)

escription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number	K022400

11

Transducer Model Number: PLT-1204AX

510(k) Control Number: K013633

| 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 | | | | | | | | | | |
| 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 | | P | P | P | | P | P | P | P | |
| Superficial | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | | P | P | P | P | |
| Other (specify) | | | | | | | | | | |

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

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

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)

Prescrip

(Division Sign-Off)

(Division Sign-Off) V
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022400

12

Transducer Model Number: PET-704LA

510(k) Control Number: K013633

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Segerson
Division Sign-Off

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

13

Transducer Model Number: PC-20M

510(k) Control Number: K013633

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppier	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:

and the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of the states of the states

Combined Modes: ______________________________________________________________________________________________________________________________________________________________

( 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)

Torrid A. Legum

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022400