CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS

K091804 · Philips Ultrasound, Inc. · ITX · Jul 17, 2009 · Radiology

Device Facts

• Record ID: K091804
• Device Name: CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS
• Applicant: Philips Ultrasound, Inc.
• Product Code: ITX · Radiology
• Decision Date: Jul 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The CX50 2.0 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following clinical applications: Cardiac (adult), Ophthalmic, Fetal, Abdominal, Pediatric, Musculoskeletal, Peripheral Vessel, Small Organ, Trans-vaginal, Adult Cephalic, and Gynecological.

Device Story

CX50 2.0 is a compact diagnostic ultrasound system; modification of CX50 (1.0) (K081802). System processes ultrasound signals from compatible transducers to produce B-mode, M-mode, Doppler (Pulse Wave, Continuous Wave, Color, Tissue), and Harmonic images. Used in point-of-care, office, and hospital settings by clinicians for diagnostic imaging and fluid flow analysis. Includes 'Integrated Ultrasound' capability for workflow facilitation with Philips Allura Xper X-ray system (K041949). Output displayed for physician interpretation to support clinical decision-making. Benefits include expanded diagnostic capabilities via new transducers and integrated workflow features.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by performance testing, adherence to electrical/physical safety standards, and comparison of acoustic output levels to Track 3 FDA limits.

Technological Characteristics

Compact diagnostic ultrasound system. Transducers: S5-1, L12-3, C9-3v, C5-1, D5cwc. Imaging modes: B, M, PWD, CWD, Color Doppler, Tissue Doppler, Harmonics (Tissue/Contrast). Features: iSCAN, X-Res, SonoCT, 3D (Freehand), Angio Imaging, Biopsy guidance. Connectivity: Integrated workflow with Allura Xper X-ray. Electrical/physical safety per FDA standards. Acoustic output: Track 3.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in adult cardiac, ophthalmic, fetal, abdominal, pediatric, musculoskeletal, peripheral vessel, small organ, trans-vaginal, adult cephalic, and gynecological applications. Used in point-of-care, office, clinical, and hospital settings.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• Philips iU22 diagnostic ultrasound system (K030455)
• CX50 (1.0) compact diagnostic ultrasound system (K081802)

Reference Devices

• Philips Allura Xper X-ray system (K041949)

Submission Summary (Full Text)

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JUL 1 7 2009

#### Summary of Safety and Effectiveness: Philips CX50 2.0 K091804

The submitter of this premarket notification is:

Rob Butler Manager, Regulatory Affairs Philips Ultrasound, Inc. 3000 Minuteman Road Andover, MA 01810-6302 Tel: [phone] Fax: [phone]

This summary was prepared on June 17, 2009.

The proprietary name of the device is the CX50 Diagnostic Ultrasound System. In combination with its compatible transducers, the system is commonly known as a diagnostic ultrasound system and transducers.

These devices are classified as follows:

| 90IYN | Ultrasonic Pulsed Doppler Imaging System |
|-------|------------------------------------------|
| 90IYO | Ultrasonic Pulsed Echo Imaging System |

90ITX Diagnostic Ultrasound Transducer

As stated in 21 CFR, parts 892.1550, 892.1560 and 892.1570, each of these generic types of devices have been classified as Class II.

CX50 2.0 is a modification of the CX50 (1.0) compact diagnostic ultrasound system cleared for Philips Ultrasound in K081802. The 2.0 modification adds 4 additional transducers for use with the CX50 system; these transducers and software changes in release 2.0 enable expanded intended uses for the CX50 system. These expanded intended uses are all within the cleared intended uses for the predicate device, Philips iU22 diagnostic ultrasound system cleared in K030455), to which CX50 2.0 is substantially equivalent.

CX50 2.0 is intended for diagnostic ultrasound imaging and fluid flow analysis.

CX50 2.0 is substantially equivalent in safety and effectiveness to the predicate identified above:

- Both the predicate device and CX50 2.0 are indicated for the diagnostic ultrasonic . imaging and fluid flow analysis.
- . Both the predicate device and CX50 2.0 have the same gray-scale and Doppler capabilities.
- Both the predicate device and CX50 2.0 use essentially the same technologies for . imaging, Doppler functions and signal processing.

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- . Both the predicate device and CX50 2.0 have acoustic output levels below the Track 3 FDA limits.
- Both the predicate device and CX50 2.0 are manufactured under equivalent quality ● systems.
- Both the predicate device and CX50 2.0 are manufactured of materials with . equivalent biosafety. The materials have been evaluated and found to be safe for this application.
- . Both the predicate device and CX50 2.0 are designed and manufactured to the same electrical and physical safety standards.

### Introduction

This 510(k) premarket notification submission has been prepared in adherence with the FDA guidance; Information for Manufactures Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, issued on September 9, 2008.

# Basic Information

#### Manufacturer's Name

Philips Ultrasound 22100 Bothell Everett Highway Bothell, WA 98021-8431

Corresponding Official for this submission Rob Butler 3000 Minuteman Rd Andover, MA 01810 Phone [phone] Fax [phone]

#### Initial distributor:

Philips Ultrasound 22100 Bothell Everett Highway Bothell, WA 98021-8431

#### Device Name

CX50 Diagnostic Ultrasound System. This submission covers the 2.0 release of CX50.

#### Common Name:

Diagnostic Ultrasound System and Transducers

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### Classification

| Regulatory Class: | II |
|-------------------|-----------|
| Review Category: | Tier II |
| Review Panel: | Radiology |

| Device Name | FR Number | Product Code |
|------------------------------------------|-----------|--------------|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |

#### Establishment Registration Number

Philips Ultrasound, Inc. 1217116

#### 514 Performance Standards

There are no Sec. 514 performance standards for this device.

#### Prescription Status

This is a prescription device. The prescription device statement appears in the labeling.

### Manufacturing Location

Philips Ultrasound 22100 Bothell Everett Highway Bothell, WA 98021-8431

### Sterilization Site(s)

Not applicable. No components supplied sterile.

#### Reason for Submission

The contents of this submission describe the 2.0 release of CX50 - modifications to the CX50 (1.0 release) system previously cleared in K081802. The changes include:

- Adding to CX50 indications for use and features that are already cleared for use on the predicate device (Philips iU22 ultrasound system -K030455)
- Adding 4 transducers to CX50; 2 have been previously cleared on other Philips ultrasound systems; 2 are minor modifications of previously cleared transducers
- Adding Antegrated Ultrasound" capability, which facilitates workflow between the CX50 and the Philips Allura Xper X-ray system (K041949).

#### Track

This is a Track 3 system.

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## Indications for Use

The CX50 2.0 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following clinical applications: Cardiac (adult), Ophthalmic, Fetal, Abdominal, Pediatric, Musculoskeletal, Peripheral Vessel, Small Organ, Trans-vaginal, Adult Cephalic, and Gynecological.

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The clinical environments where the CX50 Diagnostic Ultrasound System can be used include point-of-care areas in offices, clinical and hospital settings for diagnosis of patients.

These use models are within the scope of and substantially equivalent to current indications for use for Diagnostic Ultrasound System.

The 510(k) Indications for Use forms on the following 6 pages show previously cleared indications for use for the CX50 (1.0 release) system and indications for use added with this 2.0 release of CX50. The CX50 2.0 release made no changes to the indications for use for the X7-2t and D2cwc transducers as cleared on K081802, so no Indications for Use form is provided for those two transducers. The CX50 2.0 release does add indications for use for the S5-1 transducer from what was cleared on K081802, so an Indication for Use form for S5-T is included in this submission, showing both previously cleared and new (with CX50 2.0) indications for use.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

#### Public Health Service

JUL 1 7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Ultrasound, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K091804

Trade/Device Name: CX50 2.0 Diagnostic Ultrasound System and Transducers Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 3, 2009 Received: July 6, 2009

Dear Mr. Job:

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

This determination of substantial equivalence applies to the following transducers intended for use with the CX50 2.0 Diagnostic Ultrasound System and Transducers, as described in your premarket notification:

SS-1 L12-3 C9-3v CS-1 DScwc

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact William C. Jung at [phone].

Sincerely yours,

Hubert Reiner

ne M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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# Indications for Use

510(k) Number (if known): K091804

Device Name: __ CX50 2.0 Diagnostic Ultrasound System and Transducers

Indications for Use:

Cardiac (Adult, Trans-esophageal) (previously cleared in K081802)

Applications added in CX50 2.0: Ophthalmic Fetal Abdominal Pediatric Musculoskeletal Peripheral Vessel Small Organ Trans-vaginal Adult Cephalic Gynecological

> "Integrated Ultrasound" - capable of facilitating work flow between CX50 and Philips Allura Xper X-ray system (K041949)

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|--------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal and Radiological Devices | |
| 510(k) Number | K091804 |

Page 1 of 7

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69/804 510(k) Number:

Device name: CX50 2.0 Diagnostic Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|----------------------------------------------------------------------------|-----------------------------------------------------|-------------------|------------------|-----|-----|------------------|------------------------------------|---------------------|
| General<br>(Track I<br>Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>See below | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | N | N | N | | N | N | N (1,4,6,7) |
| | Fetal/Obstetric | N | N | N | N | N | N | N (1,3-8) |
| | Abdominal | N | N | N | N | N | N | N (1,3-9) |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | N | N | N | | N | N | N (1,3-8) |
| | Small Organ (thyroid,<br>scrotum, prostate, breast) | N | N | N | | N | N | N (1,3-8) |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | N | N | N | N | N | N | N (1,3-7) |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | N | N | N | | N | N | N (1,3-8) |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Musculo-skel<br>(conventional) | N | N | N | | N | N | N (1,3-8) |
| | Musculo-skel (superficial) | N | N | N | | N | N | N (1,3-8) |
| | Other (Gynecological) | N | N | N | | N | N | N (1,3-9) |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P(1-4) |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | P | P | P | P | P | P | P(1-4) |
| | Other (Fetal) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | N | N (1,3-8) |
| | Other (Carotid) | N | N | N | | N | N | N (1,3-8) |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | |
| *Other modes: | | | 5. Angio Imaging | | | | | |

| *Other modes: | 5. Angio Imaging |
|---------------------------------------------------------------------------------|---------------------------------------------------|
| 1. Harmonics (Tissue or Contrast) | 6. 3D (Freedhand) Imaging |
| 2. Tissue Doppler Imaging | 7. SonoCT |
| 3. iSCAN | 8. Biopsy guidance |
| 4. X-Res | 9. Infertility monitoring of follicle development |
| Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD | |

Previous submission: K081802 for first release of CX50

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiotogical Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

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

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091804 510(k) Number:

S5-1 transducer for use with CX50 2.0 Diagnostic Ultrasound System Device name: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | Mode of Operation | | | | | | | | | |
|----------------------------------------------------------------------------|-----------------------------------------------------|-------------------|---|-------------------------------------------------------------------------|---------------------------|------------------|------------------------------------|---------------------|--|--|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>See below | Other*<br>(Specify) | | |
| Ophthalmic | Ophthalmic | N | N | N | | N | N | N<br>(1,4,6,7) | | |
| | Fetal/Obstetric | | | | | | | | | |
| | Abdominal | N | N | N | | N | N | N (1,3-8) | | |
| Fetal<br>Imaging<br>& Other | Intra-operative<br>(vascular/epicardial) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (thyroid,<br>scrotum, prostate, breast) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | N | N | N | N | N | N | N (1,3-7) | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Intra-luminal | | | | | | | | | |
| | Musculo-skel<br>(conventional) | | | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | | | |
| | Other (Gynecological) | | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | P | | |
| | Cardiac | Cardiac Pediatric | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | |
| Other (Fetal) | | | | | | | | | | |
| | | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | | | |
| *Other modes: | 1. Harmonics (Tissue & Contrast) | | | | 5. Angio Imaging | | | | | |
| | 2. Tissue Doppler Imaging | | | | 6. 3D (Freedhand) Imaging | | | | | |
| 3. iSCAN | | | | 7. SonoCT | | | | | | |
| 4. X-Res | | | | 8. Biopsy guidance<br>9. Infertility monitoring of follicle development | | | | | | |
| Combined modes: B+PWD. B+Color. B+M+Color. B+Color+PWD. B+CWD. B+Color+CWD | | | | | | | | | | |

Previous submission: K081802 - use of S5-1 transducer with first release of CX50

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801,109)

(Division Sign-Off)

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

page 3 of 7

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| 510(k) Number: | K091804 | | | | | | | |
|-----------------------------|--------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|------------------------------------|---------------------|
| Device name: | L12-3 transducer for use with CX50 2.0 Diagnostic Ultrasound System | | | | | | | |
| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General | Specific | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>See below | Other*<br>(Specify) |
| (Track I<br>Only) | (Tracks I & III) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetric | | | | | | | |
| | Abdominal | N | N | N | | N | N | N (1,3-8) |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | N | N | N | | N | N | N (1,3-8) |
| | Small Organ (thyroid,<br>scrotum, prostate, breast) | N | N | N | | N | N | N (1,3-8) |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Musculo-skel<br>(conventional) | N | N | N | | N | N | N (1,3-8) |
| | Musculo-skel (superficial) | N | N | N | | N | N | N (1,3-8) |
| | Other (Gynecological) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Fetal) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | N | N (1,3-8) |
| | Other (Carotid) | N | N | N | | N | N | N (1,3-8) |
| | N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | |

*Other modes: 5. Angio Imaging 1. Harmonics (Tissue & Contrast) 6. 3D (Freedhand) Imaging 2. Tissue Doppler Imaging 7. SonoCT 3. iSCAN 8. Biopsy guidance 4. X-Res 9. Infertility monitoring of follicle development Combined modes: B+PWD, B+Color, B+M+Color, B+Color+PWD, B+CWD, B+CWD, B+Color+CWD Previous submission:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

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

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804 00 510(k) Number: Device name: C9-3v transducer for use with CX50 2.0 Diagnostic Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|----------------------------------------------------------------------------|-----------------------------------------------------|-------------------|---------------------------------------------------|-----|-----|------------------|------------------------------------|---------------------|
| General<br>(Track I<br>Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>See below | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetric | N | N | N | | N | N | N (1,3-8) |
| | Abdominal | N | N | N | | N | N | N (1,3-9) |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | |
| | Small Organ (thyroid,<br>scrotum, prostate, breast) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | N | N | N | | N | N | N (1,3-9) |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Musculo-skel<br>(conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
| | Other (Gynecological) | N | N | N | | N | N | N (1,3-9) |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Fetal) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | |
| *Other modes: | | | 5. Angio Imaging | | | | | |
| 1. Harmonics (Tissue & Contrast) | | | 6. 3D (Freedhand) Imaging | | | | | |
| 2. Tissue Doppler Imaging | | | 7. SonoCT | | | | | |
| 3. iSCAN | | | 8. Biopsy guidance | | | | | |
| 4. X-Res | | | 9. Infertility monitoring of follicle development | | | | | |

Combined modes: B+PWD, B+Color, B+M+Color, B+Color+PWD, B+CWD, B+CWD, B+Color+CWD Previous submission:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

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

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

091804 510(k) Number:

C5-1 transducer for use with CX50 2.0 Diagnostic Ultrasound System Device name: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|----------------------------------|----------------------------------------------------------------------------|-------------------|---------------------------|---------------------------------------------------|------------------|------------------|-------------------------------------|---------------------|
| General<br>(Track I<br>Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined.<br>(Specify)<br>See below | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetric | N | N | N | | N | N | N (1,3-8) |
| | Abdominal | N | N | N | | N | N | N (1,3-9) |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | N | N | N | | N | N | N (1,3-9) |
| | Small Organ (thyroid,<br>scrotum, prostate, breast) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Musculo-skel<br>(conventional) | | | | | | | |
| | Musculo-skel (superficial) | N | N | N | | N | N | N (1,3-8) |
| | Other (Gynecological) | N | N | N | | N | N | N (1,3-9) |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Fetal) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | N | N (1,3-8) |
| | Other (Specify) | | | | | | | |
| | N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | |
| *Other modes: | | | | | 5. Angio Imaging | | | |
| 1. Harmonics (Tissue & Contrast) | | | 6. 3D (Freedhand) Imaging | | | | | |
| 2. Tissue Doppler Imaging | | | 7. SonoCT | | | | | |
| 3. iSCAN | | | | 8. Biopsy guidance | | | | |
| 4. X-Res | | | | 9. Infertility monitoring of follicle development | | | | |

Combined modes: B+PWD, B+Color, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD Previous submission:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

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

page 6 of 7

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

804 91 510(k) Number:

D5cwc transducer for use with CX50 2.0 Diagnostic Ultrasound System Device name: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|------------------------------|-----------------------------------------------------|-------------------|---|-----|-----|------------------|------------------------------------|---------------------|
| General<br>(Track I<br>Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>See below | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetric | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | |
| | Small Organ (thyroid,<br>scrotum, prostate, breast) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Musculo-skel<br>(conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Fetal) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | N | | |
| | Other (Carotid) | | | | | N | | |

Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD Previous submission:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Congurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

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