HD11 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K062247 |
|---|---|
| Device Name | HD11 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Philips Ultrasound, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Aug 18, 2006 |
| Decision | SESE |
| Submission Type | Special |
| 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: Fetal, Abdominal, Pediatric, Intracardiac, Intraoperative, Musculo-skeletal, Peripheral Vascular, Small Organ, Cardiac (Adult, Pediatric, Trans-esoph), Endo-cavity (Trans-rectal, Trans-vaginal), Adult and Neonatal Cephalic, Gynecological.
Device Story
HD11 Diagnostic Ultrasound System performs diagnostic imaging and fluid flow analysis. System console generates electronic voltage pulses transmitted to connected transducers; piezo-electric arrays convert pulses into ultrasonic pressure waves. Waves reflect off body tissues; transducer converts reflected energy back to electrical signals. System processes signals into images; Doppler functions detect and display blood/tissue flow. Used in point-of-care, clinic, and hospital settings by physicians/technicians. Output displayed on screen for clinical diagnosis. Benefits include non-invasive visualization of internal structures and hemodynamics. Includes renamed transducers (C6-3, V6-2, V8-4) and integration of EP MedSystems ViewFlex catheter.
Clinical Evidence
Bench testing only. No clinical data presented. Substantial equivalence based on technological characteristics, acoustic output measurements, and comparison to predicate devices.
Technological Characteristics
Diagnostic ultrasound system; consists of console, display, and transducers. Piezo-electric array sensing. Modes: B, M, PWD, CWD, Color/Amplitude Doppler, 3D, Harmonics, combined modes. Track 3 system. Materials evaluated for biosafety. Electrical/physical safety per standard requirements.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in patients requiring screening or diagnosis in clinical, office, or hospital settings. Applications include fetal, abdominal, pediatric, cardiac, vascular, small organ, musculoskeletal, and endo-cavity imaging. 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 M2540A EnVisor (K043535)
- HDI-5000 series Ultrasound systems (K043535)
- EP MedSystems ViewMate System with ViewFlex catheter VF-PA9F64ED (K031066)
Related Devices
- K043535 — HD11 DIAGNOSTIC ULTRASOUND SYSTEM · Philips Ultrasound, Inc. · Jan 6, 2005
- K080548 — HD7 DIAGNOSTIC ULTRASOUND SYSTEM · Phillips Medical Systems · Mar 27, 2008
- K081661 — HD15 DIAGNOSTIC ULTRASOUND SYSTEM · Philips Ultrasound, Inc. · Jun 24, 2008
- K081802 — CX50 DIAGNOSTIC ULTRASOUND SYSTEM · Philips Ultrasound, Inc. · Jul 11, 2008
- K100598 — PENRITH ELETTRA ULTRASOUND SYSTEM · Penrith Corporation · Nov 19, 2010
Submission Summary (Full Text)
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### 3.2 Summary of Safety and Effectiveness
Kob2247
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 Senior manager, Regulatory Submissions Philips Ultrasound MS 0135 3000 Minuteman Road Andover, MA 01810 Tel: (978) 659-2101 Fax: (978) 975-7324
This summary was prepared on 28 June 2006
The proprietary name of the device is the HD11 Diagnostic Ultrasound System. In combination with the transducers listed in the Indications for Use tables 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 HD11 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 other ultrasound systems including the Philips M2540A EnVisor and HDI-5000 series Ultrasound systems with transducers and EP MedSystems ViewMate® System with ViewFlex™ catheter VF-PA9F64ED.
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The HD11 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 HD11 is intended for diagnostic ultrasound imaging and fluid flow analysis.
The HD11 is substantially equivalent in safety and effectiveness to the predicates identified above:
- Both the predicate device and the HD11 are indicated for the diagnostic ultrasonic imaging . and fluid flow analysis.
- Both the predicate device and the HD11 have the same gray-scale and Doppler capabilities. .
- Both the predicate device and the HD11 use essentially the same technologies for imaging, . Doppler functions and signal processing.
- Both the predicate device and the HD11 have acoustic output levels below the Track 3 ● FDA limits.
- Both the predicate device and the HD11 are manufactured under equivalent quality systems. .
- Both the predicate device and the HD11 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 HD11 are designed and manufactured to the same electrical . and physical safety standards.
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### 4.0 General Information
### 4.2 Basic Information
#### 4.2.1 Manufacturer's Name
- 4.2.1.1 Manufacturer's Name (System and Transducers) Philips Ultrasound 22100 Bothell Everett Highway Bothell, WA. 98021
### 4.2.1.2 Manufacturer's Name (Catheter)
EP MedSystems Cooper Run Executive Park 575 Route 73 North Unit D West Berlin, NJ 08091
# 4.2.2. Initial distributor
Philips Ultrasound
- 4.2.3 Device Name HD11 Diagnostic Ultrasound System
#### 4.2.4 Common Name
Diagnostic Ultrasound System and Transducers
#### Classification Name and Panel 4.2.5
Regulatory Class: II Review Tier: II
| Device Name | CFR Reference | Product Code |
|------------------------------------------|---------------|--------------|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
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#### 4.6.2 Establishment registration Number
### 4.2.6.1 Philips Ultrasound Establishment Registration Number
3019216
### 4.2.6.2 EP MedSystems Establishment Registration Number
2248049
#### 4.2.7 514 Performance Standards
There are no Sec. 514 performance standards for this device
#### 4.2.8 Special Controls: 510(k) Special Report
The 510(k) Special Report, containing the final acoustic output, Doppler Sensitivity and labeling will be submitted prior to first customer shipment.
#### 4.2.9 Prescription Status
This is a prescription device. The prescription device statement appears in the labeling.
### 4.2.10 Manufacturing Location
### 4.2.10.1 Philips Ultrasound Manufacturing Location
Philips Ultrasound 22100 Bothell Everett Highway Bothell, WA. 98021
### 4.2.10.2 EP MedSystems Manufacturing Location
EP MedSystems Cooper Run Executive Park Unit D 575 Route 73 North West Berlin, NJ 08091
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### 4.2.11 Sterilization Site(s) (EP MedSystems Catheter ONLY)
North American Sterilization & Packaging Company 17 Park Drive Franklin, NJ 07416
# 4.2.12 Reason for Submission
The contents of this submission describe an the addition of three renamed Philips ultrasound transducers: C5-2 (K043535) renamed to C6-3, 3D6-2 (K043535) renamed to V6-2, 3D8-4 (K043535) renamed to V8-4 and the addition of the EP MedSystems ViewFlex™ catheter (K031066).
### 4.2.13 Track
This is a Track 3 system. The 510(k) Special Report will be submitted prior to domestic shipments of this device.
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#### 4.3 Indications for Use
#### 4.3.1 Summary
The Philips HD11 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B, M, Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler (Color) and Amplitude Doppler (Angio), 3D, Harmonics, and combined mode (see table 4.3.2). It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
> Fetal Abdominal Pediatric Intracrdiac Intraoperative Musculo-skeletal Peripheral Vascular Small Organ Cardiac (Adult, Pediatric, Trans-esoph) Endo-cavity (Trans-rectal, Trans-vaginal) Adult and Neonatal Cephalic Gynecological
(Please see the Indications for Use Summary page in section 4.3.2)
The clinical environments where the HD11 can be used include point-of-care areas in offices, clinical and hospital settings for screening and diagnosis of patients. These use models are within the scope of and substantially equivalent to current indications for use for ultrasound systems. See Table 4.4.1.4.
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 2006
Philips Ultrasound % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K062247
Trade Name: HD11 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: August 1, 2006 Received: August 3, 2006
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 HD11 Diagnostic Ultrasound System, as described in your premarket notification:
Image /page/6/Picture/11 description: The image is a circular logo for the FDA Centennial, celebrating 1906-2006. The letters "FDA" are prominently displayed in a bold, stylized font at the center of the logo. Below the letters, the word "Centennial" is written in a smaller, cursive font. Three stars are arranged in a horizontal line beneath the word "Centennial". The entire logo is encircled by a dotted line, with text following the curve of the circle.
*Protecting and Promoting Public Health*
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!
### Transducer Model Number
# C6-3 Curved Linear V8-4 Curved Linear V6-2 Curved Linear ViewFlex™ Ultrasonic Catheter (Model# VF-PA9F64E2D)
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 or any 1 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.
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 I nitification. 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.
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Page 3 - Mr. Job
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Andrew Kang, MD at (301) 594-1212.
Sincerely yours,
David A. Lyon
Image /page/8/Picture/5 description: The image contains a handwritten word that appears to be "for". The writing is in a cursive style with the letters connected. The image is a close-up of the word, and the background is plain white.
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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#### Indications for Use Tables 4.3.2
### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
510(k) Number: 10023333 K 062247
System: Philips Ultrasound HD11 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 | P | P | P | P | P | P | P |
| | Fetal | P | P | P | P | P | P | P |
| | Abdominal | P | P | P | P | P | P | P |
| | Intra-operative<br>(Epicardial/Vascular) | P | P | P | P | P | P | P |
| | Intra-operative (Neuro) | P | P | P | P | P | P | P |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (Thyroid,<br>Scrotum, Breast) | P | P | P | P | P | P | P |
| | Neonatal Cephalic | P | P | P | P | P | P | P |
| | Adult Cephalic | P | P | P | P | P | P | P |
| | Trans-rectal | P | P | P | P | P | P | P |
| | Trans-vaginal | P | P | P | P | P | P | P |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Gynecological) | P | P | P | P | P | P | P |
| | Cardiac Adult | P | P | P | P | P | P | P |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P |
| | Trans-esoph. (Cardiac) | P | P | P | P | P | P | P |
| | Other (Fetal) | P | P | P | P | P | P | P |
| | Other (Intra-Cadriac) | N | N | N | N | N | | P |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | P | P |
| | Other (Carotid, I/O) | P | P | P | P | P | P | P |
| | Musculo-skel (conventional) | P | P | P | P | P | P | P |
| | Musculo-skel (superficial) | P | P | P | P | P | P | P |
| N= new indication: P= previously cleared by FDA: E= added under Appendix E | | | | | | | | |
* Other modes: Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D/4-D Imaging, Directional Angio Imaging, Tissue Doppler Imaging, 4D Fetal Heart, STIC (Spatial Temporal Image Correlation), SonoCT, X-Res, IMT Measures, iSCAN, 2D Doppler, Color Power Angio.
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual Mode,
Previous submission: Cleared in K043535
and Radiological Devices
510(k) Number _
(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)
David A. Stigman
(Division Sign-Off)
Division of Reproductive, Abdominal,
{10}------------------------------------------------
| 510(k) Number: K062247 | | | | | | | | |
|--------------------------------------------------------------------------------------------------------------|-------------------------------------------|---|---|-----|-----|---------------|-----------------------|---------------------|
| System: Philips Ultrasound HD11 Diagnostic Ultrasound System | | | | | | | | |
| Transducer: C6-3 Curved Linear 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 Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | P |
| | Abdominal | P | P | P | | P | P | P |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | P | P | P | | P | P | P |
| | Small Organ (Scrotum,<br>Thyroid, Breast) | P | P | P | | P | P | P |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Gynecological) | P | P | P | | P | P | P |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | P | P |
| | Other (Carotid) | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | |
| *Other modes: SonoCT, X-Res, Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio | | | | | | | | |
| Imaging, iSCAN, Doppler/2D, Color Power Angio | | | | | | | | |
| Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual | | | | | | | | |
(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)
David A. Bergman
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices 1 Q 510(k) Number ___
{11}------------------------------------------------
K062247
System: Philips Ultrasound HD11 Diagnostic Ultrasound System
V8-4 Curved Linear Transducer Transducer:
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 Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | P |
| | Abdominal | P | P | P | | P | P | P |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | P | P | P | | P | P | P |
| | Small Organ (Scrotum,<br>Thyroid, Breast) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Gynecological) | P | P | P | | P | P | P |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Fetal Heart ) | P | P | P | | P | P | P |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Carotid) | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | |
*Other modes: SonoCT, X-Res, Angio, Panoramic, Harmonics (Tissue), 3-D/4-D Imaging, Directional Angio Imaging, Fetal Heart (Spatial Temporal Image Correlation), Color Power Angio
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Real Time Biopsy, Dual
Previous submission: Cleared as 3D8-4 on K043535
(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)
David A. Seymore
(Division Sign-Off)
Division of Reproductive, Abdominal, and The Secretal Devices 51 970 between _______________________________________________________________________________________________________________________________________________________________
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ﺳﯿﺮ ﮨﮯ ﮨﯿﮟ ﮨﯿﮟ ﮨﯿﮟ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﯽ ﻣﺠﻤﻮﻋﯽ ﺁﺑﺎﺩ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﯽ ﻣﺠﻤﻮﻋﯽ ﺁﺑﺎﺩ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍ K062247
System: Philips Ultrasound HD11 Diagnostic Ultrasound System
V6-2 Curved Linear Transducer Transducer:
510(k) Number:
I ransacer .
Intended Use: Diagnostic ultrasound imaging or 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 | P | P | P | | P | P | P |
| | Abdominal | P | P | P | | P | P | P |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | P | P | P | | P | P | P |
| | Small Organ (Scrotum,<br>Thyroid, Breast) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Gynecological) | P | P | P | | P | P | P |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | P | P | P | | P | P | P |
| | Other (Fetal Heart) | P | P | P | | P | P | P |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Carotid) | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
| | N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | |
*Other modes: SonoCT, X-Res, Angio, Panoramic, Harmonics (Tissue), 3-D/4-D Imaging, Directional Angio Imaging, Fetal Heart (Spatial Temporal Image Correlation), Color Power Angio
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Real Time Biopsy, Dual
Previous submission: Cleared as 3D6-2 on K 043535, K034003
(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)
David R. Leyshon
(Division Sign-Off)
Division of Reproductive, Abdomina ਕਸ਼ਾ ਦੇ ਬਹੁਤ ਹੈ ਅਤੇ ਹੋਵਾਂ ਦੇ ਮਿਸ਼ਹਿਰ ליימיניווייטי ווי וויינו י לו
18
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062247 510(k) Number:
System: Philips Ultrasound HD11 Diagnostic Ultrasound System
ViewFlex™ Ultrasound Catheter (Model# VF-PA9F64E2D) 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 | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. | | | | | | | |
| | Other (Intra-cardiac) | P | P | P | N | P | 1, 2, 3 | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | |
| *Other modes: | | | | | | | | |
Combined modes: 1. B-Mode + M-Mode, 2. B-Mode + Pulsed Wave Doppler, 3. B-Mode + Color Doppler.
Previous submission: Cleared in K031066
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ENSE DO No . Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
Elavil A. Lozano
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal and Tadiological Devices 530x; Number ... ..........
