CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM

K123754 · Philips Ultrasound, Inc. · IYN · Dec 21, 2012 · Radiology

Device Facts

• Record ID: K123754
• Device Name: CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Philips Ultrasound, Inc.
• Product Code: IYN · Radiology
• Decision Date: Dec 21, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The CX50 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical -mode), Pulse Wave Doppler, continuous Wave Doppler, color Doppler, tissue Doppler Imaging and Harmonics (Tissue and contrast) modes. The device is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic, Intracardiac echo, Intraoperative, Laparoscopic, Fetal, Abdominal, Pediatric, Small Organ, Adult Cephalic, Neonatal Cephalic, Trans-vaginal, Musculoskeletal, Gynecological, Cardiac Adult, Cardiac pediatric, Trans-Esophogeal. (Cardiac), Peripheral Vessel, Other (Carotid).

Device Story

The CX50 is a portable, laptop-style, 128-channel cardiac ultrasound system. It processes acoustic signals from various transducers to generate B-mode, M-mode, Doppler (Pulse Wave, Continuous Wave, Color, Tissue), and Harmonic images. Used in point-of-care, clinical, and hospital settings by healthcare professionals. The system provides real-time diagnostic imaging and fluid flow analysis to assist clinicians in diagnosis. It supports specialized transducers for intracardiac echo (ICE), intraoperative, and laparoscopic applications. The device aids clinical decision-making by visualizing anatomy and blood flow, potentially improving patient management through non-invasive diagnostic assessment.

Clinical Evidence

No clinical data. The submission relies on bench testing and compliance with recognized standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993). Clinical safety and effectiveness of ultrasound systems with these characteristics are well-accepted based on predicate device performance.

Technological Characteristics

Portable, laptop-style, 128-channel ultrasound system. AC or battery powered. Employs digital electronic and fabrication technologies. Supports various transducers for B-mode, M-mode, Doppler, and Harmonic imaging. Complies with IEC 60601-1, 60601-1-1, 60601-1-2, 60601-2-37, and ISO 10993. Track 3 system.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in patients requiring Ophthalmic, Intracardiac echo, Intraoperative, Laparoscopic, Fetal, Abdominal, Pediatric, Small Organ, Adult/Neonatal Cephalic, Trans-vaginal, Musculoskeletal, Gynecological, Cardiac (Adult/Pediatric/Trans-Esophageal), and Peripheral Vessel/Carotid exams. Prescription use only.

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

• Philips Healthcare CX50 Diagnostic Ultrasound System (K111513)
• Philips Healthcare HD11 Diagnostic Ultrasound System (K062247)
• Philips iU22 (K030455)

Reference Devices

• St. Jude Medical ViewFlex Xtra catheter (K121381)

Submission Summary (Full Text)

{0}------------------------------------------------

510(k) Summary

K.123784

### 510(k) Premarket Notification CX50 Diagnostic Ultrasound System with Additional Indications

## DEC 2 1 2012

This summary of safety and effectiveness is provided as part of the Premarket Notification in compliance with 21CFR. Part 807, Subpart E, Section 807.92

#### 1) Submitter's name, address, telephone number, contact person

Penny Greco Philips Healthcare, Inc. Regulatory Affairs Specialist 3000 Minuteman Road Andover, MA 01810-6302 Tel: [phone] Fax [phone]

Date prepared: November 27, 2012

2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

Common/Usual Name: Diagnostic ultrasound system and transducers

Proprietary Name: · CX50 Diagnostic Ultrasound System Classification: Class II

| 21 CFR Section | Classification Name | Product Code |
|----------------|---------------------------------------------|--------------|
| 892.1550 | System, Imaging, Pulsed Doppler, Ultrasonic | 90 IYN |
| 892.1560 | System, Imaging, Pulsed Echo, Ultrasonic | 90 IYO |
| 892.1570 | Transducer, Ultrasonic, diagnostic | 90 ITX |

#### 3) Substantially Equivalent Devices

| Philips Healthcare CX50 Diagnostic Ultrasound System | K111513 |
|------------------------------------------------------|---------|
| Philips Healthcare HD11 Diagnostic Ultrasound System | K062247 |
| Philips iU22 (formerly known as Boris) | K030455 |

#### 3) Device Description

The CX50 Diagnostic Ultrasound System is a compact, AC or battery powered, 128 -channel, cardiac ultrasound imaging system. It uses custom digital electronic and fabrication technologies to provide diagnostic ultrasound information and is housed in a portable, laptop-style chassis.

The subject of this submission is the addition of new indications to Philips CX50 ultrasound system and the transducers that employ the new indications. The new indications include: ICE (intracardiac echo), Intraoperative, and Laparoscopic.

- The ICE indication employs St. Jude Medical's ViewFlex Xtra catheter (K121381). This ಂ indication is equivalent to that of Philips HD11 which supports the intracardiac echo indication and use of St. Jude Medical's ViewFlex ICE catheters (K062247/K 121381).
Philips Healthcare

{1}------------------------------------------------

### 510(k) Premarket Notification CX50 Diagnostic Ultrasound System with Additional Indications

- The Intraoperative indication employs the L15-7io and the C9-3io. The L15-7io was cleared. o for use with the Philips iU22 (formerly known as Boris, K030455). The C9-3io is similar to the L15-7io, but curved rather than linear.
- The laparoscopic indication employs the L10-4lap transducer that is equivalent to the L9-51ap O cleared for use with the Philips iU22 (formerly known as Boris, K030455).

#### 4) Intended Use

The CX50 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical -mode), Pulse Wave Doppler, continuous Wave Doppler, color Doppler, tissue Doppler Imaging and Harmonics (Tissue and contrast) modes. The device is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic, Intracardiac echo, Intraoperative, Laparoscopic, Fetal, Abdominal, Pediatric, Small Organ, Adult Cephalic, Neonatal Cephalic, Trans-vaginal, Musculoskeletal, Gynecological, Cardiac Adult, Cardiac pediatric, Trans-Esophogeal. (Cardiac), Peripheral Vessel, Other (Carotid).

#### 5) Technological comparison to predicate devices

With the implementation of the new indications CX50 employs the same technology as the HD11 with intracardiac echo and the iU22 with intraopertive and laparoscopic indications. The devices all use digital electronic and fabrication technologies to provide diagnostic ultrasound information. The CX50 is a Track 3 system that employs the same fundamental scientific technology as the iU22 and HD11.

#### 6) Determination of Substantial Equivalence

Non-clinical performance data

Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards:

- IEC 60601-1: Medical electrical equipment. General requirements for basic safety o and essential performance
- o IEC 60601-1-1: Medical Electrical Equipment - Part 1: General Requirements for Safety: Safety Requirements for Medical Electrical Systems
- IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for Safety - O Collateral standard: Electromagnetic Compatibility - Requirements and Tests
- IEC 60601-2-37: Medical electrical equipment. Particular requirements for the safety of o ultrasonic medical diagnostic and monitoring equipment
- ISO 10993: Biological evaluation of medical devices. 0

Quality assurance measures applied to the system design and development include, but were not limited to:

- . Rick Analysis
- Product Specifications .
- . Design Reviews
- Verification and Validation

Philips Healthcare

{2}------------------------------------------------

### 510(k) Premarket Notification CX50 Diagnostic Ultrasound System with Additional Indications

#### Summary of Clinical Tests

This release of CX50 introduces no new indications for use, modes, features, or technologies relative to the predicate devices (HD11, K062247, and iU22, K030455) that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices.

#### 7) Conclusions

CX50 with additional indications is substantially equivalent in safety and effectiveness to the predicates identified above:

- The predicate devices and CX50 with additional indications are indicated for the diagnostic . ultrasonic imaging and fluid flow analysis.
- . The predicate devices and CX50 with additional indications have the same gray-scale and Doppler capabilities.
- The predicate devices and CX50 with additional indications use essentially the same technologies . for imaging, Doppler functions and signal processing.
- . The predicate devices and CX50 with additional indications have acoustic output levels within the Track 3 FDA limits.
- The predicate devices and CX50 with additional indications are manufactured under equivalent . quality systems.
- . The predicate devices and CX50 with additional indications are manufactured of materials with equivalent bio safety. The materials have been evaluated and found to be safe for this application.
- The predicate devices and CX50 with additional indications are designed and manufactured to the . same electrical and physical safety standards.

#### 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,

#### Sterilization Site(s)

Not applicable. No components supplied sterile.

#### Track

This is a Track 3 system

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 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 representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 21, 2012

Philips Ultrasound, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO NY 55313

Re: K123754

Trade/Device Name: CX50 3.0 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasound pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: December 4, 2012 Received: December 6, 2012

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 intersule connivers price of hat 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 reductions of the Act. 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 I mis determination of Sabstanial of Ultrasound System, as described in your premarket notification:

| | Transducer Model Number | |
|-----------------------------------------|-----------------------------------------------------|------------------------------------------------------------------|
| S5-1<br>C9-3v<br>C5-1<br>D5cwc<br>D2cwc | X7-2t<br>L12-3<br>C8-5<br>S8-3<br>S12-4<br>L12-5 50 | C10-3v<br>L15-7io<br>C9-3io<br>L10-4lap<br>Medical ViewFlex Xtra |

{4}------------------------------------------------

Page 2 - Mr. Mark Job

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 it may be subject to basil as a legulations, Title 21, Parts 800 to 895. 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 r lease or ac note 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 or any I outral 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 CI K Part 807); aboning (21 OFF Part 820); and if applicable, the electronic form in the quality byool 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 I 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Mr. Joshua Nipper at [phone].

Sincerely Yours,

Janine M. Morris -S

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure(s)

{5}------------------------------------------------

## Indications for Use

510(k) Number (if known): k123754

Device Name: Philips CX50 Diagnostic Ultrasound System

Philips CX50 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 applications:

> Ophthalmic Intraoperative Laparoscopic Fetal Abdominal Pediatric Small Organ Adult Cephalic Neonatal Cephalic Trans-vaginal Musculo-skeletal Gynecological Cardiac Adult Cardiac Pediatric Trans-Esoph. (Cardiac) Intracardiac echo Peripheral Vessel Other (Carotid)

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.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Janine M. Morris -S 2012.12.21 16:56:42 -05'00'

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k123754

Page 1 of 18

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

k123754 · 510(k) Number: _

CX50 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 | | | | | | Other*<br>(Specify) |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------|-------------------|---------------------------------------------------|------------------|-----|------------------|------------------------------------|---------------------|
| General<br>(Track I<br>Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>See below | |
| Ophthalmic | Ophthalmic | P | P | P | | P | P | P (1,4,6,7) |
| | Fetal/Obstetric | P | P | P | P | P | P | P (1,3-8) |
| | Abdominal | P | P | P | P | P | P | P (1.3-9) |
| | Intraoperative<br>(vascular/epicardial) | N | N | N | | N | N | N (1,3,4,5,7) |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | N | N | N | | N | N | N (1.3.4,5,7) |
| Fetal<br>Imaging<br>& Other | Pediatric | P | P | P | | P | P | P (1,3-8) |
| | Small Organ (thyroid,<br>scrotum, prostate, breast) | P | P | P | | P | P | P (1,3-8) |
| | Neonatal Cephalic | P | P | P | P | P | P | P(1-8) |
| | Adult Cephalic | P | P | P | P | P | P | P (1,3-7) |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | P | P | P | | P | P | P (1,3-8) |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Musculo-skel<br>(conventional) | P | P | P | | P | P | P (1,3-8) |
| | Musculo-skel (superficial) | P | P | P | | P | P | P (1,3-8) |
| | Other (Gynecological) | P | P | P | | P | P | P (1,3-9) |
| | Cardiac Adult | P | P | P | P | P | P | P(1-4) |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P (1-7) |
| | Trans-esoph. (Cardiac) | P | P | P | P | P | P | P(1-4) |
| | Other (Intracardiac) | N | N | N | N | N | N | N (1-7) |
| | Other (Fetal) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | P | P (1,3-8) |
| | Other (Carotid) | P | P | P | | P | P | P (1,3-8) |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | |
| *Other modes: | | | | 5. Angio Imaging | | | | |
| 1. Harmonics (Tissue or Contrast) | | | 6. 3D 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: K111513 for CX50 | | | | | | | | |

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

Prescription Use (Per 21 CFR 801.109)

Page 2 of 18

Janine M. Morris -S 2012.12.21 16:56:15 -05'00'

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

k123754 ` 510(k) Number:

S5-1 transducer for use with CX50 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 | P | P | P | | P | P | P<br>(1,4,6,7) |
| | Fetal/Obstetric | | | | | | | |
| | Abdominal | P | P | P | | P | P | P (1,3-8) |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | |
| | Small Organ (thyroid. scrotum.<br>prostate, breast) | | | | | | | |
| | Neonatal Cephalic | P | P | P | P | P | P | P (1-8) |
| | Adult Cephalic | P | P | P | P | P | P | P (1,3-7) |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | P |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P (1-7) |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Intracardiac) | | | | | | | |
| | Other (Fetal) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Carotid) | | | | | | | |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | |
| *Other modes: | | 5. Angio Imaging | | | | | | |
| 1. Harmonics (Tissue & Contrast) | | 6. 3D Imaging | | | | | | |
| 2. Tissue Doppler Imaging | | 7. SonoCT | | | | | | |
| 3. iSCAN | | 8. Biopsy guidance | | | | | | |

9. Infertility monitoring of follicle development 4. X-Res -Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD Previous submission: K111513 CX50

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

Prescription Use (Per 21 CFR 801.109)

## Janine M. Morris -S 2012.12.21 16:55:43 -05'00'

Page 3 of 18

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

k123754 510(k) Number: C9-3v transducer for use with CX50 Diagnostic Ultrasound System Device name: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation Clinical Application Other* Color Combined General PWD CWD Specific B M (Specify) (Specify) (Tracks I & III) Doppler (Track I See below Only) Ophthalmic Ophthalmic P p P P (1,3-8) Fetal/Obstetric b P P P P P (1,3-9) Abdominal P P Intraoperative (vascular/epicardial) Intraoperative (Neuro) Laparoscopic Fetal Pediatric Imaging Small Organ (thyroid, scrotum, & Other prostate, breast) Neonatal Cephalic Adult Cephalic Trans-rectal P (1,3-9) P P P Trans-vaginal b P Trans-urethral Trans-esoph. (non-Card.) Intra-luminal Musculo-skel (conventional) Musculo-skel (superticial) P P P P P P (1,3-9) Other (Gynecological) Cardiac Adult Cardiac Pediatric Cardiac Trans-esoph. (Cardiac) Other (Intracardiac) Other (Fetal) Peripheral vessel Peripheral Vessel Other (Carotid) N= new indication; P= previously cleared by FDA; E= added under Appendix E 5. Angio Imaging *Other modes: 1. Harmonics (Tissue & Contrast) 6. 3D Imaging 2. Tissue Doppler Imaging 7. SonoCT 8. Biopsy guidance 3. iSCAN 9. Infertility monitoring of follicle development 4. X-Res Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD

Previous submission: K111513 CX50

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

Prescription Use (Per 21 CFR 801.109)

Janine M. Morris -S 2012.12.21 16:55:15 -05'00'

Page 4 of 18

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

k123754

#### 510(k) Number: C5-1 transducer for use with CX50 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 | P | P | P | | P | P | P (1,3-8) |
| | Abdominal | P | P | P | | P | P | P (1,3-9) |
| | Intraoperative (vascular/epicardial) | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | P | P | P | | P | P | P (1,3-9) |
| | Small Organ (thyroid, scrotum,<br>prostate, breast) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | P | P | P | | P | P | P (1,3-8) |
| | Other (Gynecological) | P | P | P | | P | P | P (1,3-9) |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Intracardiac) | | | | | | | |
| | Other (Fetal) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | P | P (1,3-8) |
| | Other (Carotid) | | | | | | | |
| | N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | |
| *Other modes: | | | 5. Angio Imaging | | | | | |
| 1. Harmonics (Tissue & Contrast) | | 6. 3D 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: K111513 CX50 | | | | | | | | |

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

Prescription Use (Per 21 CFR 801,109)

Janine M. Morris -S 2012.12.21 16:54:48 -05'00'

Page 5 of 18

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

| 510(k) Number: | k123754 |
|----------------|------------------------------------------------------------------------------------|
| Device name: | D5cwc transducer for use with CX50 Diagnostic Ultrasound System |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |

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

| *Other modes: | 5. Angio Imaging |
|----------------------------------|-----------------------------------------------------------------|
| 1. Harmonics (Tissue & Contrast) | 6. 3D 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: | K111513 CX50 |

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

Prescription Use (Per 21 CFR 801.109)

Janine M. Morris -S 2012.12.21 16:54:26 -05'00'

Page 6 of 18 .

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

510(k) Number: k123754 D2cwc transducer for use with CX50 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 Other* Specific B M PWD CWD Color Combined General Doppler (Specify) (Specify) (Tracks I & III) (Track I Only) Ophthalmic Ophthalmic Fetal/Obstetric Abdominal Intraoperative (vascular/epicardial) Intraoperative (Neuro) Laparoscopic Pediatric Fetal Small Organ (thyroid, scrotum, Imaging & Other prostate, breast) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Intra-luminal Musculo-skel (conventional) Musculo-skel (superficial) Other (Gynecological) Cardiac Adult P Cardiac Pediatric P Cardiac Trans-esoph. (Cardiac) Other (Intracardiac) Other (Fetal) Peripheral vessel Peripheral Vessel Other (Carotid) N= new indication; P= previously cleared by FDA; E= added under Appendix E * Other modes: Combined modes: Previous submission: K111513 CX50

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

Prescription Use (Per 21 CFR 801.109)

Janine M. Morris -S 2012.12.21 16:54:04 -05'00'

Page 7 of 18

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

k123754 510(k) Number: _

X 7-2t transducer for use with CX50 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 Doppler | Combined (Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetric | | | | | | | |
| | Abdominal | | | | | | | |
| | Intraoperative (vascular/epicardial) | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging & Other | Pediatric | | | | | | | |
| | Small Organ (thyroid, scrotum, prostate, breast) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | P | P | P | P | P | P | P (1-6) |
| | Other (Intracardiac) | | | | | | | |
| | Other (Fetal) | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | |
| | Other (Carotid) | | | | | | | |

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 Imaging |
| 3. ISCAN | 7. SonoCT |
| 4. X-Res | 8. Biopsy guidance |
| | 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: K111513 CX50

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

Prescription Use (Per 21 CFR 801.109)

Janine M. Morris -S 2012.12.21 16:53:39 -05'00'

Page 8 of 18

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

| 510(k) Number: | k123754 | | | | | | | | |
|----------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------|-----------|-------------------|------------------|------------------|------------------------------------|---------------------|--|
| Device name: | L12-3 transducer for use with CX50 Diagnostic Ultrasound System | | | | | | | | |
| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | Mode of Operation | | | | | |
| Clinical Application | | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>See below | Other*<br>(Specify) | |
| General<br>(Track I<br>Only) | Specific<br>(Tracks I & III) | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal/Obstetric | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P (1,3-8) | |
| | Intraoperative (vascular/epicardial) | | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | P | P | P | | P | P | P (1,3-8) | |
| | Small Organ (thyroid, scrotum,<br>prostate, breast) | P | P | P | | P | P | P (1,3-8) | |
| | Neonatal Cephalic | N | N | N | | N | N | N (1-8) | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Musculo-skel (conventional) | P | P | P | | P | P | P (1,3-8) | |
| | Musculo-skel (superficial) | P | P | P | | P | P | P (1,3-8) | |
| | Other (Gynecological) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Other (Intracardiac) | | | | | | | | |
| | Other (Fetal) | | | | | | | | |
| | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | P | P (1,3-8) | |
| | Other (Carotid) | P | P | P | | P | P | P (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 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: K 11513 for CX50 previously cleared indication (shown as N above); L12-3 transducer and other indications (P) cleared K091804

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

Prescription Use (Per 21 CFR 801.109)

Janine M. Morris -S 2012.12.21 16:53:13 -05'00'

{14}------------------------------------------------

Page 9 of 18

## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

k123754 510(k) Number: C8-5 transducer for use with CX50 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 | | | | | | Other*<br>(Specify) |
|-----------------------------|-----------------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | |
| Fetal<br>Imaging<br>& Other | Ophthalmic | | | | | | | |
| | Fetal/Obstetric | N | N | N | | N | N | N (1,3-8) |
| | Abdominal | N | N | N | | N | N | N (1,3-9) |
| | Intraoperative (vascular/epicardial) | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | N | N (1,3-8) |
| | Small Organ (thyroid, scrotum,<br>prostate, breast) | N | N | N | | N | N | N (1,3-8) |
| | Neonatal Cephalic | N | N | N | | N | N | N (1-8) |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Musculo-skel (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) |…