7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350

K050326 · Esaote, S.p.A. · IYN · Feb 28, 2005 · Radiology

Device Facts

• Record ID: K050326
• Device Name: 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350
• Applicant: Esaote, S.p.A.
• Product Code: IYN · Radiology
• Decision Date: Feb 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

Esaote's Model 7350 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal and Pediatric.

Device Story

The 7350 is a mainframe ultrasound system for diagnostic imaging; operates in B-Mode, M-Mode, Doppler, Color Flow Mapping, and Tissue Enhancement Imaging (TEI). Inputs are ultrasound signals from phased, convex, or linear array probes. The system processes these signals to produce real-time images on a CRT display. Used in clinical settings by healthcare professionals; supports on-screen patient data entry and annotations. Features include CD-RW storage and LAN connectivity for PC data transfer. Optional peripherals include VCRs and printers. Output assists clinicians in diagnostic assessment and clinical decision-making across various anatomical regions. Benefits include non-invasive diagnostic visualization.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Mainframe ultrasound system; CRT display; supports phased, convex, and linear array probes. Imaging frequencies: 2.0-10 MHz. Connectivity: LAN port, CD-RW drive. Electrical safety: IEC60601-1. Ultrasound safety: Track 3 (Acoustic Output Display). Includes Tissue Velocity Mapping and Tissue Enhancement Imaging (TEI).

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including cardiac, transesophageal, peripheral vascular, neonatal cephalic, small organ (thyroid, breast, testicles), musculoskeletal (conventional and superficial), abdominal, fetal, transvaginal, transrectal, and pediatric applications.

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

• 7250 Ultrasound Imaging System (K982444)
• 7250 Ultrasound Imaging System (K994369)
• 7300 Ultrasound Imaging System (K040596)

Submission Summary (Full Text)

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K050326

510(k) Summary 7350 Ultrasound Imaging System Esaote. S.p.A.

# FEB 2 8 2005 510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR¶807.92(a).

807.92(a)(1)

# Submitter Information

Carri Graham, Official Correspondent The Anson Group 7992 Castleway Drive Indianapolis, Indiana 46250 Phone: [phone] x103 Facsimile: [phone]

Esaote, S.p.A.

| Contact Person: | Carri Graham |
|-----------------|------------------|
| Date: | February 4, 2005 |

807.92(a)(2)

| Trade Name: | 7350 Ultrasound Imaging System |
|-------------------------|----------------------------------------------------------------------------------------------------|
| Common Name: | Ultrasound Imaging System |
| Classification Name(s): | Ultrasonic pulse doppler imaging system 892.1550<br>Ultrasonic pulsed echo imaging system 892.1560 |
| Classification Number: | 90IYN; 90IYO |

807.92(a)(3)

**Predicate Device(s)**

| Esaote, S.p.A. | 7250 Ultrasound Imaging System | K982444 |
|----------------|--------------------------------|---------|
| Esaote, S.p.A. | 7250 Ultrasound Imaging System | K994369 |
| Esaote, S.p.A. | 7300 Ultrasound Imaging System | K040596 |

System

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510(k) Summary 7350 Ultrasound Imaging System Esaote, S.p.A.

### 807.92 (a)(4)

### Device Description

The 7350 is a mainframe ultrasound system used to perform diagnostic general The 7500 is a first framimary modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes, Tissue Enhancement Imaging (TEI). The 7350 is equipped with a CRT Color Display. The full alphanumeric keyboard (1121). The plete on-screen data entry of patient information and on-screen annotations. The 7350 can drive phased (PA), convex (CA) and linear array (LA) probes. The 7350 is equipped with a CD-RW disk drive that can be used for image storage. Data can also be stored directly to a Personal Computer via a LAN port. Optional accessory devices available for the 7350 include an S-VHS video recorder; a monochrome or color page printer. The 7350 is equipped with an isolation transformer to adequately insulate the system's peripherals.

### 807.92(a)(5)

### Intended Use(s)

Esaote's Model 7350 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal and Pediatric.

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## 807.92(a)(6)

# Technological Characteristics

| | 7350 (This submission) | 7300 (K040596) | Megas (K982444 & 994369) |
|-------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| | IEC60601-1 | IEC60601-1 | IEC60601-1 |
| Electrical Safety<br>Ultrasound Safety | Track 3 (Acoustic Output Display) | Track 3 (Acoustic Output Display) | Track 3 (Acoustic Output Display) |
| Indication for Use | | | |
| • Cardiac | YES | YES | YES |
| • Transesophageal | YES | YES | YES |
| • Peripheral Vascular | YES | YES | YES |
| • Neonatal Cephalic | YES | YES | YES |
| • Adult Cephalic | YES | YES | YES |
| • Small organ | YES | YES | NO |
| • Musculoskeletal (conventional & superficial) | YES | YES | NO |
| • Abdominal | YES | YES | YES |
| • OB/Fetal | YES | YES | YES |
| • Transvaginal | YES | YES | YES |
| • Transrectal | YES | YES | YES |
| • Pediatric | YES | YES | YES |
| Probe Technology | | | |
| • Phased Array | YES | YES | YES |
| • Linear Array | YES | YES | YES |
| • Convex Array | YES | YES | YES |
| Doppler Probes | | | |
| Modes of operation | 2D, M-Mode, PW, CW, CFM, Amplitude Doppler, TEI | 2D, M-Mode, PW, CW, CFM, Amplitude Doppler, TEI | 2D, M-Mode, PW, CW, CFM, Amplitude Doppler, TEI |
| Imaging Frequencies | 2.0,2.5, 3.5, 5.0, 7.5, 10 MHz | 2.0,2.5, 3.5, 5.0, 7.5, 10 MHz | 2.0,2.5, 3.5, 5.0, 7.5, 10 MHz |
| CFM/Doppler Frequencies | 2.0, 2.5, 3.3, 5.0, 6.6, 8.0 MHz | 2.0, 2.5, 3.3, 5.0, 6.6 MHz | 2.0, 2.5, 3.3, 5.0 MHz |
| Tissue Velocity Mapping feature | YES | YES | NO |
| Biopsy Guidance | | | |
| Biopsy Intended Uses | General Purpose, Transrectal, Transvaginal | General Purpose, Transrectal, Transvaginal | General Purpose, Transrectal, Transvaginal |
| Biopsy Line Depth marker | 1 cm | 1 cm | 1 cm |
| Needle Guide Angle | ABS421: 20° 30°<br>ABS523: 45°<br>ABS123: 3.8° | ABS421: 20° 30°<br>ABS523: 45°<br>ABS123: 3.8° | ABS421: 20° 30°<br>ABS523: 45°<br>ABS123: 3.8° |
| | 7350 (This submission) | 7300 (K040596) | Megas (K982444 & 994369) |
| | ABS621: 25° 35° | ABS621: 25° 35° | ABS621: 25° 35° |
| Display type | CRT | LCD | LCD or CRT (optional) |
| Display Standard | SVGA | SVGA | SVGA |
| Digital Archival Capabilities | YES | YES | YES |
| DICOM Classes:<br>Media Storage, Storage<br>SCU | YES | YES | YES |
| VCR / Page Printer | YES | YES | YES |
| M&A Capabilities | Cardiac, Vascular, OB and<br>general purpose measurements | Cardiac, Vascular, OB and<br>general purpose measurements | Cardiac, Vascular, OB and<br>general purpose measurements |
| Weight | 90 kg | portable: 10 kg<br>with trolley: 40 kg | 25 kg |
| Dimensions | 60(w) x 155(h) x 90(d) cm | portable position:<br>35.5 (w) x 14 (h) x 49 (d) cm<br>use position:<br>35.5 (w) x 41 (h) x 49 (d) cm<br>with trolley:<br>50 (w) x 130 (h) x 51 (d) cm | portable position:<br>46 (w) x 23.5 (h) x 55 (d) cm<br>use position:<br>46 (w) x 23.5 (h) x 68 (d) cm |

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

FEB 2 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Esaote S.p.A. % Ms. Carri Graham The Anson Group 7992 Castleway Drive INDIANAPLOIS IN 46250

Re: K050326

Trade Name: 7350 Ultrasound Imaging System (or MyLab50) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: February 4, 2005 Received: February 9, 2005

Dear Ms. Graham:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because ermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use sutted in also 28, 1976, the enactment date of the Medical Device interstate continetee pror to May 20, 1978, extensified in accordance with the provisions of the Allentallents, of to devices marilate of Act (Act). You may, therefore, market the device, subject to Federal Food, Drug, and Oosmette Fee et. The general controls provisions of the Act include the general Controls of the Frein of the Press, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for This determination of substantial equil as a may be and the may be and in your premarket notification:

### Transducer Model Number

| PA230 | PA023 |
|-------|-------|
| PA121 | LA522 |
| PA122 | LA532 |

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### Page 2 -- Ms. Graham

| LA523 | CA123 |
|-------|--------|
| LA424 | 2.0 CW |
| CA421 | 5.0 CW |
| CA430 | EC123 |
| CA621 | TEE02 |

ff your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (See above) into ontrols. Existing major regulations affecting your device FDA it may be subject to such additional controls: "Darts 800 to 898. In addition, FDA
can be found in the Code of Federal Regulations, Title Rederal Register can be found in the Code of I cacral Regalations, and device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA \$ issualled of a substition with other requirements of the Act
that FDA has made a determination that your device on answeries - You must that FDA has made a decemination all. Jour areas by other Federal agencies. You must or any Federal statutes and regulations daministered by registration and listing (21
comply with all the Act's requirements, including, but not limited to set comply with an the Act s requirements, me, good manufacturing practice requirements as setter CFR Part 807), labeling (21 CFR Part 800); good analifan (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping as males I his determination of Substance special report. This report should complete the first device, you submit a postereditation special in production line devices, requested information, including acousine output measarements 30, 1997 "Information for Manufacturers
in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manu in Appendix CT, (enclosed) of the Center of Systems and Transducers." If the special Seeking Marketing Clearance of Diagnostic or allues (e.g., acoustic output greater than approved report is incomplete of contains anacepat of 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 The special report should be submitted in duplicated 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 This letter will anow you to ocgin manoling 5 wavalence of your device to a legally marketed notification. The I D71 miding of caseliantal varyour device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice in Joan as [phone]. Also, please note the regulation entitled, Contact the Office of Comphalled at (11 notification" (21CFR Part 807.97). You may obtain MISDrailding by ICICICleC to promatics nowledged on the Act from the Division of Small

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Page 2 – Ms. Graham

Manufacturers, International and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Collisantes are worked with insmaldsmamain.html
[phone] or at its Internet address http://www.fass.contact Rodrigo C. [phone] or at its Internet address mtp.7.www.ida.goveding and action of Rodrigo C. Perez at
If you have any questions regarding the content of this letter, please cont [phone].

Sincerely yours,

Qurilla depris...

f..

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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#### Mod.7350

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

| | | Mode of Operation | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|-----------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | | N [1] | N [3] |
| Abdominal | | N | N | N | | N | N | | N [1] | N [3] |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | N | N | N | | N [1] | N [3] |
| Small Organ (specify) [2] | | N | N | N | N | N | N | | N [1] | N [3] |
| Neonatal Cephalic | | N | N | N | N | N | N | | N [1] | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | N | N | N | | | N [1] | N [3] |
| Transesophageal | | N | N | N | N | N | | | N [1] | |
| Transrectal | | N | N | N | | N | N | | N [1] | |
| Transvaginal | | N | N | N | | N | N | | N [1] | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | N | N | N | | N [1] | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | N | N | N | N | N | | N [1] | |
| Musculo-skeletal Superficial | | N | N | N | N | N | N | | N [1] | |
| Other (specify) | | | | | | | | | | |

N=new indication; P=previously cleared by FDA; E= added under Appendix E

Additional Comments:

[1] Applicable combined modes: B+M+PW+CW+CFM+PD

[2] Small organs include Thyroid, Breast and Testicles.

[3] Tissue Harmonic Imaging

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

concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Lippman

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

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### Transducer: PA230

| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows. | | | | | | | | Mode of Operation | | |
|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-------------------|---|-------------|-----|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | N | N | N | N | N | N | | N [1] | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | N | N | N | N | N | N | | N [1] | N [3] | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculoskeletal Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| Clinical Application | A | B | M | PWD (PW) | CWD | Color Doppler (CFM) | Amplitude Doppler (PD) | Color Velocity Imaging | Combined (specify) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | N | N | N | | N | N | | N [1] | N [3] | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | N [1] | N [3] | |
| Cardiac | | N | N | N | N | | N | N | N [1] | N [3] | |
| Tranesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | N[1] | | |
| Pediatric | | N | N | N | N | N | N | | | | |
| Small Organ (specify) | | | | | | | | | N[1] | | |
| Neonatal Cephalic | | N | N | N | N | N | N | | | | |
| Adult Cephalic | | | | | | | | | N[1] | | |
| Cardiac | | N | N | N | N | N | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | N[1] | | |
| Peripheral Vascular | | N | N | N | N | N | N | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| | Mode of Operation | | | | | | | | | | |
| Clinical Application | A | B | M | PWD<br>(PW) | CWD | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>(specify) | | | | | | | | | | | |
| Intraoperative<br>Neurological | | N | N | N | N | N | N | | N [1] | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(specify) | | | | | | | | | | | |
| Neonatal Cephalic | | N | N | N | N | N | N | | N [1] | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | N | N | N | N | N | | | N [1] | | |
| Tranesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral<br>Vascular | | N | N | N | N | N | N | | N [1] | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| | Mode of Operation | | | | | | | | | | |
| Clinical Application | A | B | M | PWD<br>(PW) | CWD | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>(specify) | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | | N [1] | | |
| Small Organ<br>(specify) [2] | | N | N | N | | N | N | | N [1] | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Tranesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral<br>Vascular | | N | N | N | | N | N | | N [1] | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| | | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD<br>(PW) | CWD | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>(specify) | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | N [1] | | |
| Pediatric | | N | N | N | N | N | N | | N [1] | N [3] | |
| Small Organ<br>(specify) [2] | | N | N | N | N | N | N | | N [1] | N [3] | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Tranesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral<br>Vascular | | N | N | N | N | N | N | | N [1] | N [3] | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |

#### of the human body as follows: . . . . ﺎ.

N=new indication; P=previously cleared by FDA; E= added under Appendix E

Additional Comments:

al Comments:
[1] Applicable combined modes: B+M+PW+CW+CFM+PD

- [3] Tissue Harmonic Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED

concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel G. Legum

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

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

### Appendix F

#### PA121

# Diagnostic Ultrasound Indications for Use Form

# Fill out one form for each uitrasound system and each transducer.

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

N = new indication: P = previously cleared by FDA; E= added under Appendix E

Additional Comments:

Additional Comments:
[1] Applicable combined modes: B+PW+CFM+M+PD

[3] Tissue Harmonic Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON
Darice Subluation (ODF)Concurrence of CDRH, Office of Device

i Prescription Use

| (Division Sign-Off) | |
|--------------------------------------|---------|
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K050326 |

18

ron D

FROED)

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

### Transducer: PA122

fluid flow analysis of the human body as follows:

Since (1) == lication; P=previously cleared by FDA; E= added under Appendix E

Additional Comments:

nal Comments:
{ } } Applicable combined modes: B+M+PW+CW+CFM+PD

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PACE IF NEEDED

concurrence of CDRH, Office of Device Evaluation (ODE)

Darold h. Kyper

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

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

### Appendix F

# Diagnostic Ultrasound Indications for Use Form

# Fill out one form for each ultrasound system and each…