MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000 DIAGNOSTIC ULTRASOUND SCANNER; SP-711 SONOPROBE SYSTEM

K012239 · Hitachi Medical Corp. · IYN · Aug 10, 2001 · Radiology

Device Facts

• Record ID: K012239
• Device Name: MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000 DIAGNOSTIC ULTRASOUND SCANNER; SP-711 SONOPROBE SYSTEM
• Applicant: Hitachi Medical Corp.
• Product Code: IYN · Radiology
• Decision Date: Aug 10, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: endoscopic observation of the gastrointestinal tract (esophagus, stomach, duodenum, large intestine) and biliary system (pancreato-biliary ducts).

Device Story

The device is an ultrasound system consisting of the Hitachi EUB-525/EUB-2000 Diagnostic Ultrasound Scanner, the Fujinon SP-711UA Ultrasonic Probe Connecting Unit, a TL-1A Translator, and various PL-series probes. It is used for endoscopic ultrasound imaging of the gastrointestinal tract and biliary system. The system processes ultrasonic signals received from the probes to generate images for clinical observation. The device is operated by physicians in a clinical setting. The output is displayed to the physician to assist in diagnostic imaging, biopsy guidance, and therapeutic procedures like cryosurgery or brachytherapy. The system allows for improved visualization of internal structures, aiding in clinical decision-making and patient diagnosis.

Clinical Evidence

Bench testing only. The device relies on the substantial equivalence to previously cleared systems (K981434 and K011252) with identical technological characteristics and intended uses.

Technological Characteristics

Diagnostic ultrasound system utilizing ultrasonic probes (PL series). Connectivity via probe connecting unit and translator. System operates in B, M, PWD, CWD, Color Doppler, and Amplitude Doppler modes. Software-controlled imaging processing. Sterilization/disinfection per operation manual requirements.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, specifically for endoscopic observation of the gastrointestinal tract (esophagus, stomach, duodenum, large intestine) and biliary system (pancreato-biliary ducts). Includes guidance for biopsy, cryosurgery, and brachytherapy in relevant anatomical structures.

Regulatory Classification

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.

Predicate Devices

• Hitachi EUB-525 Diagnostic Ultrasound Scanner (K981434)
• Fujinon SP711 Sonoprobe system (K011252)

Submission Summary (Full Text)

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### 4.7 SUMMARY OF SAFETY AND EFFECTIVENESS

### 510(K) SUMMARY

#### Date Prepared June 14, 2001

#### Submitter's Information

Walter Weyburne Hitachi Medical Corporation of America 660 White Plains Road Tarrytown, NY 10591 [phone]

Joseph M. Azary III Azary Technologies LLC PO Box 2156 Huntington, CT 06484 [phone]

#### Trade Name, Common Name, Classification

The device trade names are:

- EUB-525 Ultrasound system ●
- EUB-2000 Ultrasound system .
- SP-711UA .
- SP-711 Sonoprobe system .

#### Predicate Device

The subject device consists of two separate assemblies. The Hitachi EUB-525/EUB-2000 Diagnostic Ultrasound Scanner and the Fujinon SP711 Sonoprobe system. The Fujinon SP711 Sonoprobe system is an optional add-on device for the Hitachi EUB-525/EUB-2000 which allows the EUB-525/EUB-2000 to utilize the Fujinon probes.

The Hitachi EUB-525 Diagnostic Ultrasound Scanner has previously been cleared by the FDA under 510(k) K981434. The Hitachi EUB-2000 was introduced as a modification of the EUB-525 under Appendix E of Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, dated September 30, 1997. The Fujinon SP711 Sonoprobe system was previously cleared for use with the Hitachi EUB-6000 by the FDA under 510(k) K011252.

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### Description Of The Device

The subject device consists of:

- EUB-525/EUB-2000 Diagnostic Ultrasound Scanner .
- SP-711UA Ultrasonic Probe Connecting Unit .
- TL-1A Translator .
- Probe (PL Series or PL26-7.5 Series) .
- Balloon and Sheath .

The Hitachi EUB-525/EUB-2000 operating controls and their associated functions do not change with the addition of the Fujinon SP-711 Sonoprobe system. The operating controls specific to the Fujinon SP-711 system are described in the operation manuals included with this document in Section 7.

The transducers subject to this submission are the same transducers described in the previously cleared 510(k) K011252. They are:

| PL1726-20 | PL1726-15 | PL1726-12 | PL1726-7.5 |
|-----------|-----------|-----------|------------|
| PL1926-20 | PL1926-15 | PL1926-12 | PL1926-7.5 |
| PL2226-20 | PL2226-15 | PL2226-12 | PL2226-7.5 |
| PL2220-20 | PL2220-15 | PL2220-12 | PL2220-7.5 |

The PL26-7.5 probe series includes one type for use with a balloon/sheath and the other type for use without a balloon. The only difference between probes is the structure of the tip. The probes made for use with a balloon/sheath have a groove on the tip to catch the balloon head. The probes made for use without a balloon are slightly shorter. The choice of the probe type is at the discretion of the physician. Since ultrasound waves are stronger in water, the physician may choose to use the balloon version to improve image quality. The probes made for use with a balloon/sheath are designated with a "B" (i.e. PL26B-7.5) and must be used with a balloon adapter, balloon sheath, and balloon as described in the operation manual.

#### Intended Use

Identical to device previously cleared by the FDA under 510(k) K011252. The intended use of the subject device is for endoscopic observation of the gastrointestinal tract (esophagus, stomach, duodenum, large intestine) and biliary system (pancreato-biliary ducts). The Ultrasound Device Indications Statements for each application and mode of the system/transducers are included with this document.

#### Technological Characteristics

Identical to device previously cleared by the FDA under 510(k) K011252.

#### Performance Data

Identical to device previously cleared by the FDA under 510(k) K011252.

#### Conclusion

We conclude that the subject device is as safe and effective as the predicate device. SECTION 4.7 Page 38 HITACHI EUB-5254FUB-2000 / FUJINON SP-711

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The text is in all capital letters and is evenly spaced around the circle.

AUG 1 0 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Walter Weyburne Regulatory Affairs Hitachi Medical Corporation of America Hitachi Medical Systems 660 White Plans Road TARRYTOWN NY 10591-5107

Re: K012239

Trade Name: EUB-525/EUB-2000 Diagnostic Ultrasound Scanner with Fujinon SP711UA/SP711 Sonoprobe System Regulatory Class: II/21 CFR 892.1550 Product Code: 90 IYN Regulatory Class: II/21 CFR 892.1560 Product Code: 90 IYO Dated: July 16, 2001 Received: July 17, 2001

Dear Mr. Weyburne:

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

This determination of substantial equivalence applies to the following transducers intended for use with the EUB-525/EUB-2000 Diagnostic Ultrasound Scanner, as described in your premarket notification:

| Transducer Model Number |
|-------------------------|
| PL1726-20 |
| PL1926-20 |
| PL2226-20 |
| PL2220-20 |
| PL1726-15 |
| PL1926-15 |
| PL2226-15 |
| PL2220-15 |
| PL1726-12 |
| PL1926-12 |
| PL2226-12 |

{3}------------------------------------------------

| PL2220-12 |
|------------|
| PL1726-7.5 |
| PL1926-7.5 |
| PL2226-7.5 |

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.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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 [phone].

Sincerely vours.

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)

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K012239

#### Diagnostic Ultrasound Indications for Use Form

#### System/Transducer: EUB-525/EUB-2000 System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|--------------------------------------|-------------------|----|-----|-----|------------------|----------------------|------------------------|----------------------|
| General<br>(Track 1 only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined*<br>(specify) | Other**<br>(specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>& Others | Fetal | P | P | P | P | P | P | N | P |
| | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Na | Pa |
| | Intraoperative (specify) | Pb | Pb | Pb | Pb | Pb | Pb | Nb | Pb |
| | Intraoperative (Neuro.) | | | | | | | | |
| | Laparoscopic | P | P | P | P | P | P | N | P |
| | Pediatric | P | P | P | P | P | P | N | P |
| | Small Organ (specify) | Pd | Pd | Pd | Pd | Pd | Pd | Nd | Pd |
| | Neonatal Cephalic | P | P | P | P | P | P | N | P |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | Ph | Ph | Ph | Ph | Ph | Ph | Nh | Ph |
| | Trans-vaginal | Pf | Pf | Pf | Pf | Pf | Pf | Nf | Pf |
| | Trans-urethral | | | | | | | | |
| | Trans-esophageal | | | | | | | | |
| | Muskulo-skeletal | | | | | | | | |
| | Conventional | | | | | | | | |
| | Musculo-skeletal | | | | | | | | |
| | Superficial | | | | | | | | |
| | Intra-luminal | Ni | | | | | | | |
| | Other (specify) | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | N | P |
| | Cardiac Pediatric | P | P | P | P | P | P | N | P |
| | Cardiac Transesophageal<br>Adult | P | P | P | P | P | P | N | P |
| | Cardiac Transesophageal<br>Pediatric | P | P | P | P | P | P | N | P |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vascular | P | P | P | P | P | P | N | P |
| | Other (specify) | | | | | | | | |

N=new indication; P=previously cleared by FDA under 510(k)# K981434; E=added under appendix E

*Combination of each operating mode, B, M, PWD, CWD, and Color Doppler

** Amplitude Doppler and Harmonic Imaging

Additional Comments:

Subscript "a": Includes imaging for guidaneous biopsy of abdominal organs and structures (including amniccentesis). Subscript "b": Includes imaging of organs and structures exposed during surgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.

Subscript "d": Includes thyroid, breast, scrotum, penis and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of transrectal biopsy.

Subscript "f": Includes imaging for guidance of tranvaginal biopsy.

Subscript "g": For pediatric patients.

Subscript "h": Includes imaging for guidance of transrectal biopsy, cryosurgery, and brachytherapy.

Subscript "": Includes imaging of the biliary system (pancreato-biliary) and gastrointestinal tract (esophagus, stomach, duodenum, and large intestine).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tamara C. Stockton
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
And Radiological Devices

510(k) Number:

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#### Diagnostic Ultrasound Indications for Use Form

#### System/Transducer: PL1726-20

| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|--------------------------------------|---------------------|---|-----|-----|------------------|----------------------|------------------------|----------------------|
| General<br>(Track 1 only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined*<br>(specify) | Other**<br>(specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>& Others | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intraoperative (specify) | | | | | | | | |
| | Intraoperative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esophageal | | | | | | | | |
| | Muskulo-skeletal | | | | | | | | |
| | Conventional | | | | | | | | |
| | Musculo-skeletal | | | | | | | | |
| | Superficial | | | | | | | | |
| | Intra-luminal | Pi | | | | | | | |
| | Other (specify) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Cardiac Transesophageal<br>Adult | | | | | | | | |
| | Cardiac Transesophageal<br>Pediatric | | | | | | | | |
| | Other (specify) | | | | | | | | |
| | Peripheral | Peripheral Vascular | | | | | | | |
| | Vessel | Other (specify) | | | | | | | |

N=new indication; P=previously cleared by FDA under 510(k)# K011252; E=added under appendix E

*Combination of each operating mode, B, M, PWD, CWD, and Color Doppler

** Amplitude Doppler and Harmonic Imaging

Additional Comments:

Subscript "a": Includes imaging for guidaneous biopsy of abdominal organs and structures (including amniccentesis).

Subscript "b": Includes imaging of organs and structures exposed during neurosurgery and laparoscopic procedures). Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.

Subscript "d": Includes thyroid, breast, scrotum, penis and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of transrectal biopsy.

Subscript "1": Includes imaging for guidance of tranvaginal biopsy.

Subscript "g": For pediatric patients.

Subscript "h": Includes imaging for guidance of transrectal biopsy, cryosurgery, and brachytherapy.

Subscript "": Includes imaging of the biliary system (pancreato-biliary) and gastrointesinal tract (esophagus, stomach, duodenum, and large intestine).

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

Nancy L Brogdon
(Division Sign Off)

Division

And Radiological Devices

510(k) Number: K012239

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

# Diagnostic Ultrasound Indications for Use Form

#### System/Transducer: PL1726-15

| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | | |

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|--------------------------------------|-------------------|----|-----|-----|------------------|----------------------|------------------------|----------------------|
| General<br>(Track 1 only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined*<br>(specify) | Other**<br>(specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>& Others | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intraoperative (specify) | | | | | | | | |
| | Intraoperative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esophageal | | | | | | | | |
| | Muskulo-skeletal | | | | | | | | |
| | Conventional | | | | | | | | |
| | Musculo-skeletal | | | | | | | | |
| | Superficial | | | | | | | | |
| | Intra-luminal | | Pi | | | | | | |
| | Other (specify) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Cardiac Transesophageal<br>Adult | | | | | | | | |
| | Cardiac Transesophageal<br>Pediatric | | | | | | | | |
| | Other (specify) | | | | | | | | |
| | Peripheral Vascular | | | | | | | | |
| Peripheral<br>Vessel | Other (specify) | | | | | | | | |

N=new indication; P=previously cleared by FDA under 510(k)# K011252; E=added under appendix E

* Combination of each operating mode, B, M, PWD, CWD, and Color Doppler

** Amplitude Doppler and Harmonic Imaging

Additional Comments:

Additional Comments:
Subscript "a": Includes imaging for guidaneous biopsy of abdominal organs and strestures (including annosences procedes procedes procedes procede

Subscript a : mcludes inaging of goldance of perculancede bropsy (excluding neurosurgery and laparoscopic procedures).
Subscript to: Includes imaging of organs and structures Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.

Subscript "c": includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of transrectal biopsy.

Subscript "1": Includes imaging for guidance of tranvaginal biopsy.

Subscript "g": For pediatric patients.

Subscript "h": Includes imaging for guidance of transrectal biopsy, cryosurgery, and brachytherapy.

Subscript I : Includes inaging of the billiary system (pancreato-biliary) and gastrontestinal tract (esophagus, stomach, ducdenum, and large intestine).

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

Nancy C. braggdon

hdomintal FNT Division of

510(k) Number: K012239

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

### Diagnostic Ultrasound Indications for Use Form

#### System/Transducer: PL1726-12

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|--------------------------------------|-------------------|---|-----|-----|------------------|----------------------|------------------------|----------------------|
| General<br>(Track 1 only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined*<br>(specify) | Other**<br>(specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intraoperative (specify) | | | | | | | | |
| | Intraoperative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| Fetal Imaging<br>& Others | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esophageal | | | | | | | | |
| | Muskulo-skeletal | | | | | | | | |
| | Conventional | | | | | | | | |
| | Musculo-skeletal | | | | | | | | |
| | Superficial | | | | | | | | |
| | Intra-luminal | Pi | | | | | | | |
| | Other (specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Cardiac Transesophageal<br>Adult | | | | | | | | |
| Cardiac | Cardiac Transesophageal<br>Pediatric | | | | | | | | |
| | Adult | | | | | | | | |
| | Cardiac Transesophageal | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vascular | | | | | | | | |
| | Other (specify) | | | | | | | | |

ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ

*Combination of each operating mode, B, M, PWD, CWD, and Color Doppler **Amplitude Doppler and Harmonic Imaging

Additional Comments:

Subscript "a": Includes imaging for guidaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery and laparoscopic procedures). Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.

Subscript "d": Includes thyroid, paralhyroid, breast, scrotum, penis and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of transrectal biopsy

Subscript "f": Includes imaging for guidance of tranvaginal biopsy.

Subscript "g": For pediatric patients.

Subscript "n": Includes imaging for guidance of transrectal biopsy, cryosurgery, and brachytherapy.

Subscript "": Includes imaging of the biliary system (pancreato-biliary) and gastrointestinal Iract (esophagus, stornach, ducdenum, and large intestine).

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

Marge Brogdon

Division

510(k) Number: KC

er: K012234

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

### Diagnostic Ultrasound Indications for Use Form

#### System/Transducer: PL1726-7.5

intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|--------------------------------------|-------------------|---|-----|-----|------------------|----------------------|------------------------|----------------------|
| General<br>(Track 1 only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined*<br>(specify) | Other**<br>(specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intraoperative (specify) | | | | | | | | |
| | Intraoperative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| Fetal Imaging<br>& Others | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esophageal | | | | | | | | |
| | Muskulo-skeletal | | | | | | | | |
| | Conventional | | | | | | | | |
| | Musculo-skeletal | | | | | | | | |
| | Superficial | | | | | | | | |
| | Intra-luminal | Pi | | | | | | | |
| | Other (specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Cardiac Transesophageal<br>Adult | | | | | | | | |
| Cardiac | Cardiac Transesophageal<br>Pediatric | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vascular | | | | | | | | |
| | Other (specify) | | | | | | | | |

N=new indication; P=previously cleared by FDA under 510(k)# K011252; E=added under appendix

*Combination of each operating mode, B, M, PWD, CWD, and Color Doppler

** Amplitude Doppler and Harmonic Imaging

Additional Comments:

Additional Comments.
Subscript "a": Includes imaging for guidaneous biopsy of abdominal organs and strenurser and lancessories procedes procedes procedes

Subscript a : niciouss inaging of goldane of percularied organs and structures and laparosurgery and laparoscopic procedures). Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.

Subscript "d": Includes thyroid, breast, scrotum, penis and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of transrectal biopsy.

Subscript "1": Includes imaging for guidance of tranvaginal biopsy.

Subscript "g": For pediatric patients.

Subscript "h": Includes imaging for guidance of transrectal biopsy, cryosurgery, and brachytherapy.

Subscript in : mcloces imaging of the blockers of the received inal tract (esophagus, stomach, ducdenum, and large intestine).

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

Nanny C. Brogdon
(Division Sign-Off)

Division of

510(k) Number:

K012239

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

# Diagnostic Ultrasound Indications for Use Form

#### System/Transducer: PL1926-20

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|--------------------------------------|-------------------|---|-----|-----|------------------|----------------------|------------------------|----------------------|
| General<br>(Track 1 only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined*<br>(specify) | Other**<br>(specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intraoperative (specify) | | | | | | | | |
| | Intraoperative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| Fetal Imaging<br>& Others | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esophageal | | | | | | | | |
| | Muskulo-skeletal | | | | | | | | |
| | Conventional | | | | | | | | |
| | Musculo-skeletal | | | | | | | | |
| | Superficial | | | | | | | | |
| | Intra-luminal | Pi | | | | | | | |
| | Other (specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Cardiac Transesophageal<br>Adult | | | | | | | | |
| Cardiac | Cardiac Transesophageal<br>Pediatric | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vascular | | | | | | | | |
| | Other (specify) | | | | | | | | |

**Amplitude Doppler and Harmonic Imaging Additional Comments:

Additional Comments:
Subscript "a": Includes imaging for guidaneous biopsy of abdominal organs (nouvding pourceurgen); procedi

Subscript a": Includes imaging of gularie of percularieds biopsy of abouting organd and laparoscopic procedures).
Subscript "b": Includes imaging of organs and structures exp Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.

Subscript "c": Includes thyroid, breast, scrotum, penis and imaging for guidance of biopsy.

Subscript "o": Includes imaging for guidance of transrectal biopsy.

Subscript "1": Includes imaging for guidance of tranvaginal biopsy.

Subscript "g": For pediatric patients.

Subscript "I . I or pediatio patistic of transrectal biopsy, cryosurgery, and brachytherapy.

Subscript "h": Includes imaging of thanslestal boysy, Crystirer), and practicely .
Subscript ":". Includes imaging of the biliary system (pancreato-biliary) and gastrointest large intestine).

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

Nancy C. Brogdon
(Division Sign Off)

Division of F

||

510(k) Number: K012239

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

### Diagnostic Ultrasound Indications for Use Form

#### System/Transducer: PL1926-15

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|--------------------------------------|---------------------|----|-----|-----|------------------|----------------------|------------------------|----------------------|
| General<br>(Track 1 only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined*<br>(specify) | Other**<br>(specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>& Others | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intraoperative (specify) | | | | | | | | |
| | Intraoperative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esophageal | | | | | | | | |
| | Muskulo-skeletal | | | | | | | | |
| | Conventional | | | | | | | | |
| | Musculo-skeletal | | | | | | | | |
| | Superficial | | | | | | | | |
| | Intra-luminal | | Pi | | | | | | |
| | Other (specify) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Cardiac Transesophageal<br>Adult | | | | | | | | |
| | Cardiac Transesophageal<br>Pediatric | | | | | | | | |
| | Other (specify) | | | | | | | | |
| | Peripheral<br>Vessel | Peripheral Vascular | | | | | | | |
| | | Other (specify) | | | | | | | |

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Combination of each operating mode, B, M, PWD, CWD, and Color Doppler

* Amplitude Doppler and Harmonic Imaging

Additional Comments:

Subscript "a": Includes imaging for guidaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during neurosurgery and laparoscopic procedures). Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrolum, penis and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of transrectal biopsy.

Subscript "1": Includes imaging for guidance of tranvaginal biopsy.

Subscript "g": For pediatric patients.

Subscript "h": Includes imaging for guidance of transrectal biopsy, cryosurgery, and brachytherapy.

Subscript "i": Includes imaging of the biliary system (panceato-biliary) and gastrontestinal tract (esophagus, stomach, duodenum, and large intestine).

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

Janus/C brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT
And Radiological Devices

And Radiological Devices

510(k) Number: K012239

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

# Diagnostic Ultrasound Indications for Use Form

### System/Transducer: PL1926-12

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------|-------------------|---|-----|-----|------------------|----------------------|------------------------|----------------------|
| General<br>(Track 1 only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined*<br>(specify) | Other**<br>(specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intraoperative (specify) | | | | | | | | |
| | Intraoperative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| Fetal Imaging<br>& Others | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esophageal | | | | | | | | |
| | Muskulo-skeletal | | | | | | | | |
| | Conventional | | | | | | | | |
| | Musculo-skeletal | | | | | | | | |
| | Superficial | | | | | | | | |
| | Intra-luminal | Pi | | | | | | | |
| | Other (specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| Cardiac | Cardiac Transesophageal | | | | | | | | |
| | Adult | | | | | | | | |
| | Cardiac Transesophageal | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral | Peripheral Vascular | | | | | | | | |
| Vessel | Other (specify) | | | | | | | | |

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

*Combination, I -provieusly enode B. M. PWD, CWD, and Color Doppler

** Amplitude Doppler and Harmonic Imaging

Additional Comments:

Additional Comments:
Subscript "a": Includes imaging for guidaneous biopsy of abdominal organs and structures and leaseeopling recogni

Subscript a": Includes imaging of gulance of percualledus blogs of abouting neurosurgery and laparoscopic procedures). Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.

Subscript "C": Includes thyroid, breast, scrotum, penis and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of transrectal biopsy.

Subscript "f": Includes imaging for guidance of tranvaginal biopsy.

Subscript "g": For pediatric patients.

Subscript "h": Includes imaging for guidance of transrectal biopsy, cryosurgery, and brachytherapy.

Subscript n : nclodes maging of the billiary system (pancreato-blian) and (esophagus, stomach, duodenum, and large intestine).

large intestine).
(PLEASE DO NOT V

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

Nancy L. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal,
And Radiological Devices

510(k) Number: K

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

### Diagnostic Ultrasound Indications for Use Form

#### System/Transducer: PL1926-7.5

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|--------------------------------------|---------------------|---|-----|-----|------------------|----------------------|------------------------|----------------------|
| General<br>(Track 1 only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined*<br>(specify) | Other**<br>(specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intraoperative (specify) | | | | | | | | |
| | Intraoperative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| Fetal Imaging<br>& Others | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esophageal | | | | | | | | |
| | Muskulo-skeletal | | | | | | | | |
| | Conventional | | | | | | | | |
| | Musculo-skeletal | | | | | | | | |
| | Superficial | | | | | | | | |
| | Intra-luminal | Pi | | | | | | | |
| | Other (specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Cardiac Transesophageal<br>Adult | | | | | | | | |
| Cardiac | Cardiac Transesophageal<br>Pediatric | | | | | | | | |
| | Other (specify) | | | | | | | | |
| | Peripheral | Peripheral Vascular | | | | | | | |
| | Vessel | Other (specify) | | | | | | | |

N=new indication; P=previously cleared by FDA under 510(K)# R

*Combination of each operating mode, B, M, PWD, CWD, and Color Doppler

** Amplitude Doppler and Harmonic Imaging

Additional Comments:

Subscript "a": Includes imaging for guidaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during neurosurgery and laparoscopic procedures). Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy,

Subscript "e": Includes imaging for guidance of transrectal biopsy.

Subscript "f": Includes imaging for guidance of tranvaginal biopsy.

Subscript "g": For pediatric patients.

Subscript "h": Includes imaging for guidance of transrectal biopsy, cryosurgery, and brachytherapy.

Subscript ":" Includes imaging of the biliary system (pancreato-biliary) and gastrointestinal tract (esophagus, stomach, and large intestine).

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

Nancy C. Gurydon
(Division Sign Off)

Division of

510(k) Number: KD12239

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

# Diagnostic Ultrasound Indications for Use Form

### System/Transducer: PL2226-20

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | B | M | PWD | CWD | Mode of Operation<br>Color<br>Doppler | Amplitude<br>Doppler | Combined*<br>(specify) | Other**<br>(specify) |
|---------------------------|--------------------------------------|----|---|-----|-----|---------------------------------------|----------------------|------------------------|----------------------|
| General<br>(Track 1 only) | Specific<br>(Tracks I & III) | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intraoperative (specify) | | | | | | | | |
| | Intraoperative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | |…