M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540

K014191 · Philips Medical Systems · IYN · Jan 7, 2002 · Radiology

Device Facts

• Record ID: K014191
• Device Name: M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540
• Applicant: Philips Medical Systems
• Product Code: IYN · Radiology
• Decision Date: Jan 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: [Clinical Application Table entries for various transducers including Ophthalmic, Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal/Adult Cephalic, Trans-rectal, Trans-vaginal, Gynecological, Cardiac, Peripheral Vessel, and Musculo-skeletal].

Device Story

M2540 Diagnostic Ultrasound System; console-based system with display and interchangeable transducers. System generates electronic voltage pulses sent to transducers; piezo-electric arrays convert pulses to ultrasonic pressure waves. Waves transmit through body tissues; reflected energy converted back to electrical signals. Advanced signal processing converts signals into tissue images; Doppler functions process frequency shifts from moving targets (blood) to display flow. Used in clinical settings by trained professionals. Output provides visual diagnostic information for clinical decision-making; aids in assessment of anatomy and hemodynamics.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technological characteristics, acoustic output measurements, and compliance with safety standards for diagnostic ultrasound systems.

Technological Characteristics

System console with power supply, electronic circuitry, and display. Transducers utilize piezo-electric arrays. Modes: B, M, PWD, CWD, Color Doppler, Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio, Doppler Tissue Imaging. Combined modes: Duplex (2D+Doppler), Triplex (2D+Doppler+Color). Acoustic output complies with Track 3 FDA limits. Electrical/physical safety per standard medical device requirements.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis of human body tissues and blood flow. Patient population includes adults, pediatrics, and neonates depending on the specific transducer and clinical application (e.g., cardiac, abdominal, fetal, vascular, small organ).

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

• M2410 Ultrasound system

Submission Summary (Full Text)

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K014191

## JAN 0 7 2002

#### 3.2 Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 as implemented in 21 C.F.R. §807.92.

The submitter of this premarket notification is:

Steve Singlar Regulatory Engineer Philips Medical Systems Philips Ultrasound Division 3000 Minuteman Road, MS 0135 Andover, MA 01810 Tel: [phone] Fax: [phone]

This summary was prepared on November 19, 2001.

The proprietary name of the device is the M2540 Diagnostic Ultrasound System. In combination with the new transducers - 21373B, 21422A, 21426A, 21475A - are 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.

The M2540 is a diagnostic ultrasound device. It consists of a system console containing the power supply and electronic circuitry required to generate the image, a display screen, and a connection to the separate transducers. It is substantially equivalent to the ultrasound systems including the M2410 Ultrasound system with transducers.

The 21422A. 21425A. 21446A. 21475A transducers are substantially equivalent to the Philips sector, linear and endo-cavity ultrasound transducers.

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The M2540 system and transducers function in a manner identical to all ultrasound systems and transducers. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo-electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The differing acoustic properties of the tissues in the body reflect some of the transmitted energy back to the transducer, where it is converted back to electrical signals and sent back to the system. In the system, advanced signal processing technologies convert the returned signals into images of the tissues. The Doppler functions of this system process the Doppler shift frequencies from the echoes of moving targets (such as blood), to detect and graphically display the Doppler shifts of these tissues as flow.

The M2540 is intended for diagnostic ultrasound imaging and fluid flow analysis.

The M2540 is substantially equivalent in safety and effectiveness to the predicates identified above:

- Both the predicate device and the M2540 are indicated for the diagnostic ultrasonic imaging ● and fluid flow analysis.
- Both the predicate device and the M2540 have the same gray-scale and Doppler capabilities. .
- Both the predicate device and the M2540 use essentially the same technologies for imaging, ● Doppler functions and signal processing.
- Both the predicate device and the M2540 have acoustic output levels below the Track 3 . FDA limits.
- Both the predicate device and the M2540 are manufactured under equivalent quality systems. .
- . Both the predicate device and the M2540 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 M2540 are designed and manufactured to the same electrical . and physical safety standards.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three parallel lines that curve to form the shape of a head and shoulders. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 0 7 2002

Phillips Medical Systems % Mr. Mark Job 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891

Re: K014191

Trade Name: M2540 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasound pulsed doppler imaging system Regulatory Class: II Product Code: 90 IYN Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYO Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 ITX Dated: December 20, 2001 Received: December 21, 2001

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 M2540 Diagnostic Ultrasound System, as described in your premarket notification:

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#### Transducer Model Number

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 (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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

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The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarket 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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Robert A Phillips at [phone].

Sincerely yours.

Nancy C brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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K014191

#### Indications for Use Tables 4.3.2

### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

510(k) number: K_014 |91

Device name: Philips Medical Systems M2540 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<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | N | N | N | N | N | N | N |
| Fetal Imaging<br>& Other | Fetal | N | N | N | N | N | N | N |
| | Abdominal | N | N | N | N | N | N | N |
| | Intra-operative<br>(vascular/epicardial) | N | N | N | N | N | N | N |
| | Intra-operative (Neuro) | N | N | N | N | N | N | N |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N |
| | Small Organ (thyroid, scrotum, breast) | N | N | N | N | N | N | N |
| | Neonatal Cephalic | N | N | N | N | N | N | N |
| | Adult Cephalic | N | N | N | N | N | N | N |
| | Trans-rectal | N | N | N | N | N | N | N |
| | Trans-vaginal | N | N | N | N | N | N | N |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Gynecological) | N | N | N | N | N | N | N |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N |
| | Cardiac Pediatric | N | N | N | N | N | N | N |
| | Trans-esoph. (Cardiac) | N | N | N | N | N | N | N |
| | Other (Fetal) | N | N | N | N | N | N | N |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | N | N |
| | Other (Specify) | | | | | | | |
| | Musculo-skel (conventional) | N | N | N | N | N | N | N |
| | Musculo-skel (superficial) | N | N | N | N | N | N | N |

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

* Other modes: Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging, Doppler Tissue Imaging

Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color NO previous 510(k) submissions are associated with this product.

(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

Nancy C. Hergdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K014191
510(k) Number

RA

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510(k) Number: K

Philips Medical Systems M2540 Diagnostic Ultrasound System System:

Transducer: 21221B (C1914C) Non-Imaging Pencil transducer

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

| Clinical Application | | Mode of Operation | | | | | | Other* (Specify) |
|----------------------------------------------------------------------------|------------------------------|-------------------|---|-----|-----|------------------|-----------------------|------------------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | N | | | |
| Cardiac | Cardiac Pediatric | | | | N | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | |
| *Other modes include: None | | | | | | | | |
| Combined modes: None. | | | | | | | | |
| Previous submission: K002470. Adult & Pediatric cardiac | | | | | | | | |

.

(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

Nancy C. Broadion

(Division Sign-Ofm
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K014191

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510(k) Number: K

Philips Medical Systems M2540 Diagnostic Ultrasound System System: Transducer: 21223B (D5014V) Non-Imaging Pencil transducer

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) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| Fetal Imaging<br>& Other | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | N | N | | | |
| | Other (Specify) | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | |
| *Other modes: None | | | | | | | | |
| Combined modes: None | | | | | | | | |

Previous submission: K002470, Peripheral vascular

(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)

:

MauricShridon

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510(k) Number: K

Philips Medical Systems M2540 Diagnostic Ultrasound System System:

Transducer: 21228B (D1914V) Non-imaging pencil transducer

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) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | N | N | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | N | | | | |
| | Other (Specify) | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |

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

| *Other modes: | None |
|----------------------|---------------------------------|
| Combined modes: | None |
| Previous submission: | K002470 for Peripheral vascular |

(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)

Nancy Chrzdon

510(k) Num

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510(k) Number: K

Philips Medical Systems M2540 Diagnostic Ultrasound System System:

Transducer: 21321A (C3540) Curved linear array transducer

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) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | N | | N | N | N |
| | Abdominal | N | N | N | | N | N | N |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | N | N | N | | N | N | N |
| | Small Organ (thyroid,<br>scrotum, breast) | N | N | N | | N | N | N |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Gynecological) | N | N | N | | N | N | N |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | N | N |
| | Other (Specify) | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |

N= new indication; P= previously cleared by FDA; E= added under Appendix E *Other modes: Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color Previous submission: K002470 for fetal, abdominal and PV; K990400 for fetal, pediatic, abdominal, small parts and PV

(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

Ylancy C. Hugdon

(Division St and Radiolo 510(k) Numb

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510(k) Number: K

Philips Medical Systems M2540 Diagnostic Ultrasound System System:

Transducer: 21330A (S4) Sector transducer

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) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | N | N | N | N | N | N | N |
| | Fetal | N | N | N | N | N | N | N |
| | Abdominal | N | N | N | N | N | N | N |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | N | N | N | N | N | N | N |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | N | N | N | N | N | N | N |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Gynecological) | N | N | N | N | N | N | N |
| | Cardiac Adult | N | N | N | N | N | N | N |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | N | N |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | N | N |
| | Other (Specify) | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |

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

*Other modes: Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging, Doppler Tissue Imaging

Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color

Previous submission: K002470 for Abdominal, Adult Cephalic, Cardiac, PV, Fetal and Ophthalmic; K990400 for Abdominal, Adult cephalic, Adult Cardiac; K990339 for Abdominal, Adult cephalic, Cardiac, Fetal and Ophthalmic; K980687 for Abdominal, Adult Cephalic, Fetal, Adult Cardiac, Ophthalmic and Harmonic Imaging

(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

Nancy Croglon
Sign-Off

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

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

510(k) Number: K

Philips Medical Systems M2540 Diagnostic Ultrasound System System:

Transducer: 21336A (E6509) Endocavity transducer

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) | Other*<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | N | N | N | | N | N | N | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | | | | | | | | |
| | Small Organ (Prostate) | N | N | N | | N | N | N | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | N | N | N | | N | N | N | |
| | Trans-vaginal | N | N | N | | N | N | N | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (Gynecological) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | | |

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

*Other modes: Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging, Doppler Tissue Imaging

Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color

Previous submission: K990339 for Fetal, Endorectal, Endovaginal, Small Parts; K972348 Endovaginal, Endorectal, Gynecological, Obstetrics, Urological

(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

Vancie Scizdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K014191

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510(k) Number: K

Philips Medical Systems M2540 Diagnostic Ultrasound System System:

Transducer: 21350A (S8) Sector transducer

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) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | N | | N | N | N |
| | Abdominal | N | N | N | N | N | N | N |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | N | N | N | N | N | N | N |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | N | N | N | | N | N | N |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Pelvic) | N | N | N | N | N | N | N |
| | Cardiac Adult | N | N | N | N | N | N | |
| Cardiac | Cardiac Pediatric | N | N. | N | N | N | N | N |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | N | N |
| Vessel | Other (Specify) | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |

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

*Other modes: Angio, Panoramic, 3-D Imaging, Directional Angio Imaging, Doppler Tissue Imaging Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color

Previous submission: K002470 for abdominal, adult & pediatric cardiac

(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

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

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

510(k) Number: K

Philips Medical Systems M2540 Diagnostic Ultrasound System System:

Transducer: 21359A (L7535) Linear array transducer

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) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | N | N | N | | N | N | N |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | N | N |
| | Small Organ (thyroid, scrotum, breast) | N | N | N | | N | N | N |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | N | N |
| | Other (Specify) | | | | | | | |
| | Musculo-skel (conventional) | N | N | N | | N | N | N |
| | Musculo-skel (superficial) | | | | | | | |

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

*Other modes: Angio, Panoramic, 3-D Imaging, Directional Angio Imaging

Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color

Previous submission: K954028 for PV, Pediatrics, Abdominal, Small Parts, and Musculo-skeletal (conventional)

(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

Nancy C. Scagdon

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

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

510(k) Number: K

Philips Medical Systems M2540 Diagnostic Ultrasound System System:

Transducer: 21360A (L5035) Linear array transducer

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) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | N | N | N | | N | N | N |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | N | N | N | | N | N | N |
| | Small Organ (thyroid,<br>scrotum, breast) | N | N | N | | N | N | N |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | N | N |
| | Other (Specify) | | | | | | | |
| | Musculo-skel (conventional) | N | N | N | | N | N | N |
| | Musculo-skel (superficial) | | | | | | | |

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

*Other modes: Angio, Panoramic, 3-D Imaging, Directional Angio Imaging

Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color

Previous submission: K954028 for Vascular, Pediatrics, Musculo-Skeletal (conventional) and Abdominal.

(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

Nancy C. Brogdon

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

{15}------------------------------------------------

510(k) Number: K

Philips Medical Systems M2540 Diagnostic Ultrasound System System:

Transducer: 21369A (Omni II) TEE Sector transducer

I ransuccer. - 21.0071 (Outrasound 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) | Other*<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | | | | | | | | |
| | Small Organ (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| | Cardiac Adult | N | N | N | N | N | | N | |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | | N | |
| | Trans-esoph. (Cardiac) | N | N | N | N | N | N | N | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | | |
| | N= new indication; P= previously cleared by FDA; E= added under Appendix E<br>*Other modes: Angio, Doppler Tissue Imaging, Directional Angio | | | | | | | | |

Combined modes: Duplex = 2D + Doppler

Previous submission: K954028 for Adult & pediatric cardiac, transesophageal

(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)

:

Nancy brondon

(Division Sign-Off) Division of Reproductive, and Radiological Devices 51 (Xk) Number -

{16}------------------------------------------------

510(k) Number: K

Philips Medical Systems M2540 Diagnostic Ultrasound System System:

Transducer: 21373A (C5040) Curved Linear array transducer

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) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | N | | N | N | N |
| | Abdominal | N | N | N | | N | N | N |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | N | N | N | | N | N | N |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | |…