CX50 DIAGNOSTIC ULTRASOUND SYSTEM

K111513 · Philips Ultrasound, Inc. · IYN · Jun 24, 2011 · Radiology

Device Facts

• Record ID: K111513
• Device Name: CX50 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Philips Ultrasound, Inc.
• Product Code: IYN · Radiology
• Decision Date: Jun 24, 2011
• 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, Fetal, Abdominal, Pediatric, Small Organ, Adult Cephalic, Neonatal Cephalic, Trans-vaginal, Musculo-skeletal, Gynecological, Cardiac Adult, Cardiac pediatric, Trans-Esoph. (Cardiac), Peripheral Vessel, Other (Carotid)

Device Story

The CX50 is a portable, laptop-style, 128-channel diagnostic ultrasound system; AC or battery-powered. It processes ultrasonic signals to generate B-mode, M-mode, Doppler (Pulse Wave, Continuous Wave, Color, Tissue), and Harmonic imaging. Used in point-of-care, clinical, and hospital settings by clinicians for diagnostic imaging and fluid flow analysis. The system utilizes custom digital electronics to transform transducer inputs into diagnostic images/data. Output is displayed for clinician review to support clinical decision-making. This 510(k) adds Cardiac Pediatric and Neonatal Cephalic indications to an existing platform; no new technical features introduced.

Clinical Evidence

No clinical data was generated for this submission. The safety and effectiveness of the CX50 system were established in previous submissions (K091804, K081802). The added Cardiac Pediatric and Neonatal Cephalic indications are well-accepted for ultrasound systems, including the predicate HD11 (K043535).

Technological Characteristics

Portable, laptop-style 128-channel ultrasound system. Employs pulsed echo and pulsed Doppler imaging. Supports various transducers (e.g., S5-1, L12-3, C9-3v, C5-1, D5cwc, D2cwc, X7-2t). Operates under Track 3 FDA limits. Connectivity includes standard ultrasound imaging modes (B, M, Doppler, Harmonics, Tissue Doppler).

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in patients requiring Ophthalmic, Fetal, Abdominal, Pediatric, Small Organ, Adult/Neonatal Cephalic, Trans-vaginal, Musculo-skeletal, Gynecological, Cardiac (Adult/Pediatric/Trans-Esophageal), and Peripheral Vessel/Carotid examinations.

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

• CX50 Diagnostic Ultrasound System (K091804 / K081802)
• HD11 Diagnostic Ultrasound System (K043535)

Submission Summary (Full Text)

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

K111513

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

JUN 2 4 2011

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

Date prepared: May 23, 2011

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 Name: Class II

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

3) Substantially Equivalent Devices

| CX50 Diagnostic Ultrasound System | K091804 / K081802 |
|-----------------------------------|-------------------|
| HD11 Diagnostic Ultrasound System | K043535 |

#### 3) Device Description

The CX50 Diagnostic Ultrasound System is a compact, AC or battery powered, 128 channel, cardiac ultrasound imaging. It uses custom digital electronic and fabrication technologies to provide diagnostic ultrasound information and is housed in a portable, laptop-style chassis. The only changes made in this CX50 510(k) are the additional indications of Cardiac Pediatric and Neonatal Cephalic. There are no new or unique features/technical characteristics introduced with the addition of the new indications.

Page 6 of 33

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

Cardiac Pediatric and Neonatal Cephalic indications have been previously cleared for other Philips Ultrasound systems, including the predicate device, HD11 Ultrasound system (K043535). This modification to the CX50 involves only the two new indications, as reflected in labeling.

#### 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, Fetal, Abdominal, Pediatric, Small Organ, Adult Cephalic, Neonatal Cephalic, Trans-vaginal, Musculo-skeletal, Gynecological, Cardiac Adult, Cardiac pediatric, Trans-Esoph. (Cardiac), Peripheral Vessel, Other (Carotid)

#### 5) Technological comparison to predicate devices

Philips CX50 and HD11 Diagnostic Ultrasound are Track 3 systems that employ the same fundamental scientific technology.

#### 6) Determination of Substantial Equivalence

### Non-clinical performance data

No new hazards were identified with the addition of cardiac pediatric and neonatal cephalic indications. No new testing was required to determine safety and efficacy of the CX50 with the new indications.

#### Summary of Clinical Tests

The CX50 required no modifications to support the neonatal cephalic and cardiac pediatric indications. The clinical safety and effectiveness of the system and transducers were identified in previous CX50 submissions (K091804 and K081802). The clinical safety and effectiveness of the Neonatal Cephalic and Cardiac Pediatric indications are well accepted for use with ultrasound systems including the predicate device, Philips HD11 (K043535).

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

### 7) Conclusions

CX50 with additional indications is substantially equivalent in safety and effectiveness to the predicate 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 . below 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.

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

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

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

JUN 2 4 2011

Re: K111513

Trade/Device Name: Philips CX50 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 31, 2011 Received: June 1, 2011

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 Philips CX50 Diagnostic Ultrasound System, as described in your premarket notification:

> Transducer Model Number ટર-I L12-3

C9-3v C2-1 D5-cwc D2cwc X7-2t

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

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 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 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 (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html 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 Joshua Nipper at [phone].

Sincerely Yours,

Mary S Patil

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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

### Indications for Use

510(k) Number (if known): KIJ1513

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 Fetal Abdominal Pediatric Small Organ Adult Cephalic Neonatal Cephalic Trans-vaginal Musculo-skeletal Gynecological Cardiac Adult Cardiac Pediatric Trans-Esoph. (Cardiac) 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.

Prescription Use _ X (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 In Vitro Diagnostic Devices (OIVD)

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

510(k) K111513

Page 1 of 9

ﺳﺮﺓ ﺍﻟﺘﻮﺩﻳ

24 11:52 :

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

મારા ક

CX50 Diagnostic Ultrasound System Device name:

510(k) Number: _

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 (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) |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| 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 | N | N | N | N | N | N | N(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 | Cardiac Adult | P | P | P | P | P | P | P(1-4) |
| | Cardiac Pediatric | N | N | N | N | N | N | N (1-7) |
| | Trans-esoph. (Cardiac) | P | P | P | P | P | P | P(1-4) |
| | 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:<br>1. Harmonics (Tissue or Contrast) | | | | | | 5. Angio Imaging<br>6. 3D (Freedhand) 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: K091804 for 2.0 release of CS50 | |

(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 9

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

1111513 510(k) Number: _

S5-1 transducer for use with CX50 Diagnostic Ultrasound System Device name:

Intended Use: Diagnostic ultrasound imaging or tluid 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) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | |
| | Small Organ (thyroid, scrotum,<br>prostate, breast) | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | N | N (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 | N | N | N | N | N | N | N (1-7) |
| | 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, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD | | | | | | | |

Previous submission: K091804 – use of S5-1 transducer with the 2.0 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 In Vitro Diagnostics

Prescription Use (Per 21 CFR 801.109)

| (Division Sign-Off) |
|---------------------|
|---------------------|

Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

| 510K | K111513 |
|------|---------|
|------|---------|

Page 3 of 9

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

1111513 510(k) Number:

L12-3 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 | | | | | | | | | |
|----------------------------------|----------------------------------------------------------------------------|---------------------------|--------------------|-----------|-----|------------------|------------------------------------|---------------------|--|--|
| 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 | P | P | P | | P | P | P (1,3-8) | | |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | | | |
| | Intra-operative (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 | | | | | | | | | |
| | 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 (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 (Freedhand) Imaging | | | | | | | | |
| | 2. Tissue Doppler Imaging | | | 7. SonoCT | | | | | | |
| 3. iSCAN | | | 8. Biopsy guidance | | | | | | | |

Previous submission: K091804- use of L12-3 transducer with the 2.0 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 In Vitro Diagnostics

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

Prescription Use (Per 21 CFR 801.109)

4. X-Res ·

| (Division Sign-Off) | |
|------------------------------------------------------------|---------|
| Division of Radiological Devices | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | |
| 510K | K111513 |

9. Infertility monitoring of follicle development

Page 4 of 9

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

K111513 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:

| 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) | | | |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | | | | |
| | Small Organ (thyroid, scrotum,<br>prostate, breast) | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | P | P | P | | P | P | P (1,3-9) | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | |
| | Intra-luminal | | | | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | | | | |
| | Other (Gynecological) | P | P | P | | P | P | P (1,3-9) | | | |
| | Cardiac Adult | | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | |
| | Other (Fetal) | | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |

Previous submission: K091804 - use of C9-3v transducer with the 2.0 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 In Vitro Diagnostics

Prescription Use (Per 21 CFR 801.109)

| (Division Sign-Off) |
|---------------------|
|---------------------|

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

| 510K | K111513 |
|------|---------|
|------|---------|

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

111513 510(k) Number:

Device name: C5-1 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 | | | | | | | |
|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-------------------|---------------------------|-----|-----|------------------|---------------------------------------------------|---------------------|--|
| 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) | |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | | |
| | Intra-operative (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 | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| Peripheral<br>Vessel | Other (Fetal) | | | | | | | | |
| | Peripheral vessel | P | P | P | | P | P | P (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 | | | | | | |
| | | | | | | | 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: K091804- use of C5-1 transducer with the 2.0 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 In Vitro Diagnostics

Prescription Use (Per 21 CFR 801.109)

| (Division Sign-Off) | |
|------------------------------------------------------------|---------|
| Division of Radiological Devices | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | |
| 510K | K111513 |

Page 6 of 9

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

1111513 510(k) Number: J

D5cwc 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 | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative | | | | | | | | | |
| | (vascular/epicardial) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Laparoscopic | | | | | | | | | |
| | 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 Adult | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | N | | | N (1-7) | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Other (Fetal) | | | | | | | | | |
| Peripheral | Peripheral vessel | | | | P | | | | | |
| Vessel | Other (Carotid) | | | | P | | | | | |
| | N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | | |
| *Other modes: | | | | | | | | | | |
| | 1. Harmonics (Tissue & Contrast) | | | | | | | | | |
| | 2. Tissue Doppler Imaging | | | | | | | | | |
| 3. iSCAN | | | | | | | | | | |
| 4. X-Res | | | | | | | | | | |

Combined modes: B+PWD, B+Color, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD Previous submission: K091804- use of D5cwc transducer with the 2.0 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 In Vitro Diagnostics

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

| 510K | K111513 |
|------|---------|
|------|---------|

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

| 510(k) Number: | K111573 |
|----------------|------------------------------------------------------------------------------------|
| Device name: | D2cwc 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 | | | | | |
|---------------------------|--------------------------------------------------|---|-------------------|-----|-----|---------------|--------------------|------------------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging & Other | Fetal/Obstetric | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | 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 | | | | P | | | |
| | Cardiac Pediatric | | | | N | | | N (1-7) |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Fetal) | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

| N= new indication; P= previously cleared by FDA; E= added under Appendix E |
|----------------------------------------------------------------------------|
| * Other modes: |
| Combined modes: |

Previous submission: K081802- use of D2cwc transducer with the 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 In Vitro Diagnostics

Prescription Use (Per 21 CFR 801.109)

| (Division Sign-Off) |
|------------------------------------------------------------|
| Division of Radiological Devices |
| Office of In Vitro Diagnostic Device Evaluation and Safety |

| 510K | K111513 |
|------|---------|
|------|---------|

Page 8 of 9

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

KII 213 510(k) Number:

Device name: X7-2t transducer for use with CX50 Diagnostic Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Property 1.7 Mode of Operation

| 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) | Other*<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal/Obstetric<br>Abdominal<br>Intra-operative<br>(vascular/epicardial)<br>Intra-operative (Neuro)<br>Laparoscopic<br>Pediatric<br>Small Organ (thyroid, scrotum,<br>prostate, breast)<br>Neonatal Cephalic<br>Adult Cephalic<br>Trans-rectal<br>Trans-vaginal<br>Trans-urethral<br>Trans-esoph. (non-Card.)<br>Intra-luminal<br>Musculo-skel (conventional)<br>Musculo-skel (superficial)<br>Other (Gynecological) | | | | | | | | |
| Cardiac | Cardiac Adult<br>Cardiac Pediatric<br>Trans-esoph. (Cardiac)<br>Other (Fetal) | P | P | P | P | P | P | P | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| | N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | |

* Other modes: Harmonics (Tissue & Contrast), Tissue Doppler Imaging

| Combined modes: | B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD |
|----------------------|-----------------------------------------------------------------|
| Previous submission: | K081802- use of X7-2t transducer with the 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 In Vitro Diagnostics

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

| 510K | K111513 |
|------|---------|
|------|---------|

Page 9 of 9