ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY)
Device Facts
| Record ID | K971528 |
|---|---|
| Device Name | ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY) |
| Applicant | Fujinon, Inc. |
| Product Code | IYO · Radiology |
| Decision Date | Dec 12, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
Intended Use
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Device Story
The SP-701 Endoscopically Deliverable Ultrasound Point Probe System is a diagnostic ultrasound device designed for intra-luminal imaging. It utilizes various transducer models (e.g., PL-1726, PL-1926, PL-2226 series) operating at frequencies of 12, 15, or 20 MHz. The system captures ultrasound signals from within the body, which are processed to produce diagnostic images. It is intended for use by trained healthcare professionals in a clinical setting. The output is displayed for the clinician to visualize internal structures, aiding in clinical assessment and decision-making. The device is subject to prescription use requirements.
Clinical Evidence
Bench testing only. The clearance is based on the demonstration of substantial equivalence to existing diagnostic ultrasound systems, with a requirement for post-clearance submission of acoustic output measurements to verify safety parameters.
Technological Characteristics
The system consists of an ultrasound console and various transducer models (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). Transducers operate at 12, 15, or 20 MHz. The device is designed for intra-luminal imaging. It is a prescription-use device subject to 21 CFR 892.1560, 892.1570, and 892.1500.
Indications for Use
Indicated for diagnostic ultrasound imaging or Doppler analysis of the human body, specifically for intra-luminal applications.
Regulatory Classification
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.
Special Controls
*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.
Related Devices
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- K012239 — MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000 DIAGNOSTIC ULTRASOUND SCANNER; SP-711 SONOPROBE SYSTEM · Hitachi Medical Corp. · Aug 10, 2001
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Submission Summary (Full Text)
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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.
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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)
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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<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Total | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac<br>Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | X | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral<br>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
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| | 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<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac<br>Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | X | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral<br>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<br>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<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac<br>Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | X | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral<br>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<br>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<br>PL=1726-12<br>SP-701 | 12 MHZ<br>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<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac<br>Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | X | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral<br>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<br>510 (k) Number if known) : ___________________________________________________________________________________________________________________________________________________<br>Transducer<br>20 MHz |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | PL-1926-20<br>SP-701<br>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<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac<br>Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | X | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral<br>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<br>17 MHz<br>P1-1926-12<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
### 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<br>Application | A | B | M | PWD | CVD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac<br>Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | X | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral<br>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<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac adult | | | | | | | | | | |
| Cardiac<br>Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | X | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral<br>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<br>CARDA | K971528 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|--------|--------|--------------------------|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Nami | Pan 701 | 6<br>19776-11-1 | ransducer<br>1 20 1 200<br>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<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac<br>Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | X | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral<br>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<br>510(k) Number (if known) : ___________________________________________________________________________________________________________________________________________________ | |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | 12 MHz Transducer | |
| Device Name: | SP-701 PL-2226-12<br>property and the program and any and the program and the comments of<br>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<br>Application | A | B | M | PVD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac<br>Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | X | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral<br>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)
x-1
{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<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac<br>Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | X | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral<br>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<br>Application | A | B | M | PVD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac<br>Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | X | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral<br>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<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac<br>Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | X | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral<br>vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
DO NOT US TFP THE THE P
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