Predicate Devices

The provided text does not contain any predicate devices with K/DEN numbers. Therefore, I cannot extract them.

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided text does not mention AI, ML, or any related concepts like deep learning, neural networks, or specific algorithms typically associated with AI/ML in medical imaging. The description focuses on the hardware components and intended use of a standard ultrasound system.

Therapeutic

No
The device is described as for "Diagnostic ultrasound imaging or Doppler analysis," indicating a diagnostic rather than therapeutic purpose.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or Doppler analysis of the human body."

SaMD (Software as a Medical Device)

No

The device description explicitly mentions "transducers" and a "Point Probe System," which are hardware components essential for ultrasound imaging.

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 is "Diagnostic ultrasound imaging or Doppler analysis of the human body". This describes a device that interacts directly with the patient's body to produce images or analyze blood flow.
Device Description: The description confirms it's an "Endoscopically Deliverable Ultrasound Point Probe System". This is a medical device used for imaging within the body.
Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The provided information does not mention any interaction with specimens or analysis performed outside the body.

Therefore, this device falls under the category of a medical imaging device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Intra-luminal

Product codes

90 IYO, 90 ITX, 78 KOG

Device Description

Endoscopically Deliverable Ultrasound Point Probe System (SP-701)
Transducer Model Number: PL-1726-20, PL-1726-15, PL-1726-12, PL-1926-20, PL-1926-15, PL-1926-12, PL-2226-20, PL-2226-15, PL-2226-12

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Intra-luminal

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)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the bird symbol.

DEC 1 2 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Gary A. Adler Fuginon, Inc. c/o Marks and Murase 399 Park Avenue New York, NY 10022-4689 Re: K971528 Endoscopically Deliverable Ultrasound Point Probe System (SP-701) Dated: September 19, 1997 Received: September 19, 1997 Regulatory Class: II 21 CFR 892.1560/Procode: 90 IYO 21 CFR 892.1570/Procode: 90 ITX 21 CFR 892.1500/Procode: 78 KOG

Dear Mr. Adler:

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 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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Encoscopically Deliverable Ultrasound Point Probe System (SP-701), as described in your premarket notification:

Transducer Model Number

PL-1726-20	PL-1726-15	PL-1726-12	PL-1926-20
PL-1926-15	PL-1926-12	PL-2226-20	PL-2226-15
PL-2226-12

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.

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.

1

Page - 2 - Mr. Gary A. Adler

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 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 Paul Gammell, Ph.D., at (301) 594-1212.

Sincerely yours,

William Yin

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

2

1971528 510(k) Number (دي known) . Bliverable Ultrasound Point Probe System Device Name: SP-701

Fill our one form for each ultrasound system or transducer.

Diagnostic ultrasound imaging or Doppler analysis Indications For Use: (Specify) of the human body as follows:

Hode of Operation

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Total | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac
Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | X | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral
vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

PLEASE DO NOT WRITE BELOW THIS LINE-OFFICE OR AGENCY BANK IT (FEDERAL)

Comments of CDR, Steffen at Purdue Polytechnic (153)

William Ym
Division Sign Off

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

Prescription Use (Per 21 CFR 801.109)

:

K-1

3

	8971528
	510(k) Number if known) : 20 MHz Transducer
	Company of the country of the count of the contribution of the commend of the management of the manufactures of

Fill our one form for each ultrasound system or cransducer.

Diagnostic ultrasound imaging or Dopplar analysis Indications For Use: (Spacify) of the human body as follows: Hode of Operation

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac
Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | X | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral
vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

PLEASE DO MOT VRETT EFLOW THIS of C

William Yri

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

510(k) Number K971528

Prescription Use (Per 21 CFR 801.109)

K-1

4

1

Ultrasound Device Indications Statement Page

K971528
510 (k) Number : if known) : _________________________________________________________________________________________________________________________________________________
15 MHz Transducer
Device Name: SP-701 PL1726-15

Fill our one form for each ultrasound system or cransducer.

Diagnostic ultrasound imaging or Doppler analysis Indications For Use: (Specify) of the human body as follows:

Mada of Operation

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac
Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | X | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral
vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

LET DATE DO MOT WELLER BERLON THE CHE CHER CHEFFECT CAL . . . . . . . . . . . . . .

William Y

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

Prescription Use (Per 21 CFR 801.109)

K-1

5

| | 8971528
510(k) Number if known): ___ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: __ | Comments of Children Comments of Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Childr
PL=1726-12
SP-701 | 12 MHZ
Transducer |

Fill out one form for each ultrasound system or cransducer.

Diagnostic ultrasound imaging or Doppler analysis Indications For Use: (Specify) of the human body as follows:

Mode of Operation

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac
Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | X | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral
vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

OPLEASE DO OF VELTY 395.09 THIS LINE . CONTINUT ON ANOTHER PAGE IT I .! CORE, Office

William Yi

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

510(k) Number

X-1

6

| | 1971528
510 (k) Number if known) : ___________________________________________________________________________________________________________________________________________________
Transducer
20 MHz |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | PL-1926-20
SP-701
and and a many and the many of the many of the many of the many of |

Fill out one form for each ultrasound system or cransducer.

Diagnostic ultrasound imaging or Doppler analysis Indications For Use: (Specify) of the human body as follows:

Mode of Operazion

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac
Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | X | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral
vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

LIULPASE DO NOT GRITTY BELOW THES I T PACE 3 .

William Yis
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Device

K-1

・・

Prescription Use (Per 21 CFR 801.109)

.

510(k) Number

7

510(k) Number (if known):	K971528
Device Name:	SP-701 PL-1926-15 15 MHz Transducer

Fill out one form for each ultrasound system or cransducer.

Diagnostic ultrasound imaging or Doppler analysis Indications For Use: (Specify) of the human body as follows:

Hase of Operacina

Clinical Application	A	B	M	PWD	CWD	Color Doppler	Power (Amplitude) Doppler	Color Velocity Imaging	Combined (Specify)	Other (Specify)
Ophthalmic
Focal
Abdominal
Intra-operative (Specify)
Intra-operative Neurological
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Trans-esophageal
Trans-rectal
Trans-vaginal
Intra-luminal		X
Trans-urethral
Peripheral vessel
Laparoscopic

(PLEASE DO MOT WRITT BELOW THE SHIP CO

K-J

William Yin

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

Radiological Devices
510(k) Number K971528

8

	510(k) Number (if known) : _	K971528
Device Name :	SP-701	Transducer
17 MHz
P1-1926-12
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Fill out one form for each ultrasound system or transducer.

Diagnostic ultrasound imaging or Doppler analysis Indications For Use: (Specify) of the human body as follows: Nada of Operation

| Clinical
Application | A | B | M | PWD | CVD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac
Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | X | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral
Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

(PLEASE DO NOT VELLE BELLEW THIS LINE CON of CDIE, OLLI

Prescription Use (Per 21 CFR 801.109)

William Y

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

x-1

510(k) Number K9715

9

	K971528	510(k) Number if known): -- 2226-20 20 ME Transducer

	Device Name: _________________________________________________________________________________________________________________________________________________________________

Fill our one form for each ultrasound system or cransducer.

Diagnostic ultrasound imaging or Doppler analysis Indications For Use: (Specify) of the human body as follows:

Hads of Operation

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac adult | | | | | | | | | | |
| Cardiac
Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | X | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral
vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

PLEASE DO NOT WRITE BELOW THIS LINE - FOR OJP STATISTICAL REVIEW
Commission on Crime, Office of Justice Planning (OJP)

K-1

William

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

510(k) Number K971528

10

| 510(k) | Number | To the days and
CARDA | K971528 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|--------|--------|--------------------------|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Nami | Pan 701 | 6
19776-11-1 | ransducer
1 20 1 200
The first and the contract and any and the comments of the county of |

Fill our one form for each ultrasound system or transducer.

Diagnostic ultrasound imaging or Doppler analysis Indicacions For Use: (Specify) of the human body as follows: Mode of Operacion

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac
Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | X | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral
vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

(PLEASE DO MOT 93779 9972 I THETE T.THE ... PH

William Y

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K971528

K-1

. . . .

11

, "

10 Ultrasound Device Indications Statement Page 13

| | K971528
510(k) Number (if known) : ___________________________________________________________________________________________________________________________________________________ | |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | 12 MHz Transducer | |
| Device Name: | SP-701 PL-2226-12
property and the program and any and the program and the comments of
Status and American and Comments of | |

Fill our one form for each ultrasound system or transducer.

Diagnostic ultrasound imaging or Doppler analysis Indications For Use: (Specify) of the human body as follows:

Hode of Operation

| Clinical
Application | A | B | M | PVD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac
Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | X | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral
vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Comencenes of Cf, Office of Device Evaluation (CDI)

William

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

510(k) Number K971528

Prescription Use (Per 21 CFR 801.109)

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12

Ultrasound Device Indications Statement Page__________________________________________________________________________________________________________________________________ 13

K971528 510(k) Number (if known): _ SP-701 PL-2220-20 20 MHz Transducer Device Name:_

Fill out one form for each ultrasound system or transducer.

Diagnostic ultrasound imaging or Doppler analysis Indications For Use: (Specify) of the human body as follows:

Hose of Operacion

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac
Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | X | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral
vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

SE DO NOT WRITE BELOW THES LINE - Office

K-1

13

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ 510(k) Number (TE known) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fill out one form for each ultrasound system or transducer.

Indications For Use: Diagnostic ultrasound imaging or Doppler analysis (Specify) of the human body as follows: Node of Operation

| Clinical
Application | A | B | M | PVD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac
Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | X | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral
vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Other Indications or Modes: | | | | | | | | | | |

100% US TTP S 197.0% THE C

14

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ 12 MHz Transducer

Fill our one form for each ultrasound system or transducer.

Indications For Use: Diagnostic ultrasound imaging or Doppler analysis (Specify) of the human body as follows: Mode of Operation

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac
Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | X | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral
vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

DO NOT US TFP THE THE P

Q