(11 days)
Not Found
No
The document describes standard ultrasound technology and signal processing for image generation and Doppler analysis. There is no mention of AI, ML, or related concepts in the device description, intended use, or any other section.
No
The "Intended Use / Indications for Use" section explicitly states that the device is for "Diagnostic ultrasound imaging or fluid flow analysis of the human body," indicating a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body." Additionally, the "Device Description" section begins by stating "The HD15 is a diagnostic ultrasound device."
No
The device description explicitly states it consists of a system console, power supply, electronic circuitry, display screen, and connection to transducers, all of which are hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This device is a diagnostic ultrasound system that uses sound waves to create images of structures within the human body. It does not analyze blood, urine, tissue biopsies, or any other sample taken from the patient.
- The description focuses on imaging and fluid flow analysis in vivo. The intended use and device description clearly state that it is used for "diagnostic ultrasound imaging or fluid flow analysis of the human body" and describes how it transmits and receives ultrasonic waves to create images of tissues.
- There is no mention of analyzing biological samples. The entire description revolves around the physical interaction of ultrasound waves with the body's tissues and fluids.
Therefore, this device falls under the category of diagnostic imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The HD15 is intended for diagnostic ultrasound imaging and fluid flow analysis.
The HD15 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal, Abdominal, Intra-operative (vascular/epicardial, Neuro), Laparoscopic, Pediatric, Small Organ (thyroid, scrotum, breast, prostate), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skel (conventional, superficial), Intra-luminal, Other (Gynecological), Cardiac (Adult, Pediatric, Trans-esoph. (Cardiac)), Peripheral vessel, Other (Carotid, I/O).
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, and ITX
Device Description
The HD15 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.
The HD15 system and transducers function in a manner identical to all Philips 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Ophthalmic, Fetal, Abdominal, Intra-operative (vascular/epicardial, Neuro), Laparoscopic, Pediatric, Small Organ (thyroid, scrotum, breast, prostate), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skel (conventional, superficial), Intra-luminal, Other (Gynecological), Cardiac (Adult, Pediatric, Trans-esoph. (Cardiac)), Peripheral vessel, Other (Carotid, I/O).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.
0
510(k) Premarket Notification
JUN 2 4 2008
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. 8807.92.
The submitter of this premarket notification is:
William Picatti Manager, Regulatory Affairs Philips Ultrasound, Inc. 22100 Bothell Everett Highway Bothell, WA 98021-8431 Tel: (425) 487-7151 Fax: (425) 487-8666
This summary was prepared on May 12, 2009.
The proprietary name of the device is the HD15 Diagnostic Ultrasound System. In combination with transducers - 3D9-3v, BP10-5ec, C5-2, C6-3, C8-4v, C8-5, D2cwc, L 12-3, L 12-5, L 15-7io, S5-2, S8-3, S7-2omni and V6-2 - 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 |
- Diagnostic Ultrasound Transducer 90ITX
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 HD15 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 currently marketed HD11 Diagnostic Ultrasound System (K043535 and K062247).
1
Image /page/1/Picture/1 description: The image shows the text "K08166", "pg. 2 of 2", and "HD15 Diagnostic Ultrasound system". The text appears to be handwritten and typed. The text "K08166" and "pg. 2 of 2" are handwritten and are located at the top of the image. The text "HD15 Diagnostic Ultrasound system" is typed and is located at the bottom of the image.
The HD15 system and transducers function in a manner identical to all Philips 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 HD15 is intended for diagnostic ultrasound imaging and fluid flow analysis.
The HD15 is substantially equivalent in safety and effectiveness to the predicates identified above:
- . Both the predicate device and the HD15 are indicated for the diagnostic ultrasonic imaging and fluid flow analysis.
- . Both the predicate device and the HD15 have the same gray-scale and Doppler capabilities.
- Both the predicate device and the HD15 use essentially the same technologies for . imaging, Doppler functions and signal processing.
- . Both the predicate device and the HD15 have acoustic output levels below the Track 3 FDA limits.
- . Both the predicate device and the HD15 are manufactured under equivalent quality systems.
- . Both the predicate device and the HD15 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 HD15 are designed and manufactured to the same electrical and physical safety standards.
2
Image /page/2/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 overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2008
Philips Ultrasound, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K081661
Trade/Device Name: Philips Ultrasound, Inc. HD15 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: June 12, 2008 Received: June 13, 2008
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 Ultrasound, Inc. HD15 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
3D9-3v 4D Endovaginal BP10-5ec Endocavity C5-2 Curved Linear Array C6-3 Curved Linear (C8-4v) Endovaginal C8-5 Curved Linear
3
D2cwc Non-image Pencil L12-3 Linear Array L12-5 50mm Linear Array L15-7io Linear Array S5-2 Sector Phased Array S7-2 omni TEE Phased Array S8-3 Sector Phased Array V6-2 Mechanical 3D
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 1 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 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.
4
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 Lauren Hefner at (240) 276-3666.
Sincerely yours,
loni M Whay
lancy C. Brogdon E Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
5
4.3.2 Indications for Use Tables
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
K081661
Philips Ultrasound, Inc. HD15 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 | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (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 | ||||||||
| (vascular/epicardial) | N | N | N | N | N | N | N | |
| Intra-operative (Neuro) | N | N | N | N | N | N | N | |
| Laparoscopic | N | N | N | N | N | N | N | |
| Fetal Imaging | ||||||||
| & Other | 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 | N | N | N | N | N | N | N | |
| Trans-esoph. (non-Card.) | N | N | N | N | N | N | N | |
| Musculo-skel (conventional) | N | N | N | N | N | N | N | |
| Musculo-skel (superficial) | N | N | N | N | N | N | N | |
| Intra-luminal | N | N | N | N | N | N | N | |
| 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) | N | N | N | N | N | N | N | |
| Other (specify) | N | N | N | N | N | N | N | |
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | N |
| Other (Carotid, I/O) | N | N | N | N | N | N | N |
= new indication; P= previously cleared by FDA; E=added under Appendix E
*Other modes: Panoramic, Color Power Angio (CPA, formerly Angio), 3D/4D, Harmonics (Tissue and Contrast), Directional Angio Imaging, Tissue Doppler Imaging.
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color
(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
Signature Sign Off
6
208166 510(k) Number:
System: Philips Ultrasound, Inc. HD15 Diagnostic Ultrasound System
Transducer: 3D9-3v 4D Endovaginal transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | |||||||
| Small Organ (Prostate) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | P | P | P | P | P | P | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Trans-esoph. (Cardiac) | |||||||
| Other (specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) | ||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||
| *Other modes: Color Power Angio, Panoramic, 3D/4D Imaging, Directional Angio Imaging | ||||||||
| Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color | ||||||||
| Previous submission: First use on this ultrasound system (See 4.4.1.4) |
(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
Arque Arthing
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
7
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
1081661
System: Philips Ultrasound, Inc. HD15 Diagnostic Ultrasound System
Transducer: BP10-5ec Endocavity transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (vascular/epicardial) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | |||||||
| Small Organ (scrotum) | P | P | P | P | P | P | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | P | P | ||
| Trans-vaginal | P | P | P | P | P | P | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Carotid, I/O) | ||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||
| *Other modes: Color Power Angio, Panoramic, Harmonics (Tissue & Contrast), 3D/4D Imaging, Directional Angio | ||||||||
| Imaging, Tissue Doppler Imaging |
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color
Previous submission: First use on this ultrasound system (See 4.4.1.4)
(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
lonai Th. Whang
Islon of Reproductive, Abdominal, a adiological ! 610(k) N
8
510(k) Number: System: Philips Ultrasound, Inc. HD15 Diagnostic Ultrasound System
Transducer: C5-2 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 | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | P | P | P | P | P | P | |
| Abdominal | P | P | P | P | P | P | ||
| Intra-operative | ||||||||
| (vascular/epicardial) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (thyroid, | ||||||||
| scrotum, breast) | P | P | P | P | P | P | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | P | P | P | P | P | P | ||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | P | |
| Other (Carotid, I/O) | ||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||
| *Other modes: Color Power Angio, Panoramic, Harmonics (Tissue & Contrast), 3D/4D Imaging, Directional Angio |
Imaging,
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color Previous submission: First use on this ultrasound system (See 4.4.1.4)
(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)
Aomi McWhan
(Division Sign-Off) Division of Reproductive, Abdomina Radiological Devices 510(k) Number
9
Cardiac
Peripheral
Vessel
| 510(k) Number: | 19081641 | |||||||
|---|---|---|---|---|---|---|---|---|
| System: | Philips Ultrasound, Inc. HD15 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 | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | ||
| Intra-operative | ||||||||
| (vascular/epicardial) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | P | P | P | P | P | P | |
| Small Organ (thyroid, | ||||||||
| scrotum, breast) | P | P | P | P | P | P | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) |
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM 120811000
N= new indication; P= previously cleared by FDA; E= added under Appendix E *Other modes: Color Power Angio, Panoramic, Harmonics (Tissue & Contrast), 3D/4D Imaging, Directional Angio
P
P
P
Imaging, Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual
P
P
P
P
P
P
P
P
P
Previous submission: First use on this ultrasound system (See 4.4.1.4)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEBDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
Intra-luminal
Other (Gynecological) Cardiac Adult
Cardiac Pediatric Trans-esoph. (Cardiac) Other (Specify)
Peripheral vessel
Other (Carotid, VO)
Aoru Tn Whan
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
10
1081661 510(k) Number:
System: Philips Ultrasound, Inc. HD15 Diagnostic Ultrasound System
Transducer: (C8-4v) Endovaginal transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | P | P | P | P | P | P | |
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (vascular/epicardial) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (thyroid, | ||||||||
| scrotum, breast) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | P | P | P | P | P | P | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Carotid, I/O) | ||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||
| *Other modes: Color Power Angio, Panoramic, 3D/4D Imaging, Directional Angio Imaging | ||||||||
| Combined modes: Duplex = 2D + Doppler, Triplex = 2D + Doppler + Color | ||||||||
| Previous submission: First use on this ultrasound system (See 4 4 1 4) |
(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
Arzu M. Khan
(Division Sign-Off) ision of Reproductive, Abdominal, and Radiological Devices 510(k) Number
11
K081661 510(k) Number:
System: Philips Ultrasound, Inc. HD15 Diagnostic Ultrasound System
Transducer: C8-5 Curved linear Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | P | P | P | P | P | P | |
| Abdominal | P | P | P | P | P | P | ||
| Intra-operative | ||||||||
| (vascular/epicardial) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (thyroid, | ||||||||
| scrotum, breast) | ||||||||
| Neonatal Cephalic | P | P | P | P | P | P | ||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | P | P | P | P | P | P | ||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | P | |
| Other (Carotid, I/O) | ||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||
| *Other modes: Color Power Angio, Panoramic, 3D/4D Imaging, Harmonics (Tissue), Directional Angio Imaging, | ||||||||
| Tissue Doppler Imaging |
Combined modes: Duplex = 2D + Doppler, Triplex = 2D + Doppler + Color, Dual
Previous submission: First use on this ultrasound system (See 4.4.1.4)
(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)
Arzne M. Whtz
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
12
510(k) Number:
System: Philips Ultrasound, Inc. HD15 Diagnostic Ultrasound System
Transducer: D2cwc Non-Imaging Pencil
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | ||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| (Track I Only) | (Tracks I & III) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (vascular/epicardial) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | |||||||
| Small Organ (thyroid, | ||||||||
| scrotum, breast) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac Adult | P | |||||||
| Cardiac | Cardiac Pediatric | P | ||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Carotid, I/O) | ||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||
| *Other modes include: None | ||||||||
| Combined modes: None. | ||||||||
| Previous submission: First use on this ultrasound system (See 4.4.1.4) |
(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)
Sidn-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
13
510(k) Number: System: Philips Ultrasound, Inc. HD15 Diagnostic Ultrasound System
Transducer: L12-3 Linear array transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | P | P | ||
| Intra-operative | ||||||||
| (vascular/epicardial) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | P | P | P | P | P | P | |
| Small Organ (thyroid, | ||||||||
| scrotum, breast) | P | P | P | P | P | P | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel (conventional) | P | P | P | P | P | P | ||
| Musculo-skel (superficial) | P | P | P | P | P | P | ||
| Intra-luminal | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | P | |
| Other (Carotid, I/O) | P | P | P | P | P | P |
previo usiy cle ared by FD. ﺔ, ﻟ *Other modes: Color Power Angio, Panoramics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging
Combined modes: Duplex = 2D + Doppler, Triplex = 2D + Doppler + Color Previous submission: First use on this ultrasound system (See 4.4.1.4)
(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
Tori In Whang
(Division ar-Off Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
14
K081661 510(k) Number:
System: Philips Ultrasound, Inc. HD15 Diagnostic Ultrasound System
Transducer: L12-5 50mm Linear array transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | ||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| (Track I Only) | (Tracks I & III) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | P | P | ||
| Intra-operative | ||||||||
| (vascular/epicardial) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | Pediatric | P | P | P | P | P | P | |
| & Other | Small Organ (thyroid, | |||||||
| scrotum, breast) | P | P | P | P | P | P | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel (conventional) | P | P | P | P | P | P | ||
| Musculo-skel (superficial) | P | P | P | P | P | P | ||
| Intra-luminal | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | P | |
| Vessel | Other (Carotid, I/O) | |||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||
| *Other modes: Color Power Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio | ||||||||
| Imaging, Tissue Doppler Imaging |
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color
Previous submission: First use on this ultrasound system (See 4.4.1.4)
(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)
Aoyce M. Wher
Division of Reproductive, Abdomina Radiolo 510(k) Numb
15
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
K08166
System: Philips Ultrasound, Inc. HD15 Diagnostic Ultrasound System
L15-7io Linear array transducer Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color Doppler | Combined | ||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (vascular/epicardial) | P | P | P | P | P | P | ||
| Intra-operative (Neuro) | P | P | P | P | P | P | ||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | P | P | P | P | P | P | |
| Small Organ (thyroid, | ||||||||
| scrotum, breast) | P | P | P | P | P | P | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel (conventional) | P | P | P | P | P | P | ||
| Musculo-skel (superficial) | P | P | P | P | P | P | ||
| Intra-luminal | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | P | |
| Other (Carotid, I/O) | P | P | P | P | P | P | ||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||
| *Other modes: Amplitude Doppler, Panoramic, Directional Angio Imaging | ||||||||
| Combined modes: Duplex = 2D + Doppler, Triplex = 2D + Doppler + Color | ||||||||
| Previous submission: First use on this ultrasound system (See 4.4.1.4) |
(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)
Lorne M. Why
(Division Sign (Division of Sign-Ull)
Division of Reproductive, Abdominal, and Radiological De 510(k) Number
Page 24
16
510(k) Number:
System: Philips Ultrasound, Inc. HD15 Diagnostic Ultrasound System
Transducer: S5-2 Sector phased array transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (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 | ||||||||
| (vascular/epicardial) | P | P | P | P | P | P | P | |
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | P | P | P | P | P | P | P |
| Small Organ (thyroid, | ||||||||
| scrotum, breast) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | P | P | P | P | P | P | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) | ||||||||
| 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) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | P | P |
| Other (Carotid, I/O) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
*Other modes: Color Power Angio, Panoramic, Harmonics (Tissue & Contrast), 3D/4D Imaging, Directional Angio Imaging, Tissue Doppler Imaging
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color
Previous submission: First use on this ultrasound system (See 4.4.1.4)
(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
tons mhm
(Division S Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number
17
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
Koflidel
System: Philips Ultrasound, Inc. HD15 Diagnostic Ultrasound System
Transducer: S7-2 omni TEE phased array transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (vascular/epicardial) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (thyroid, | ||||||||
| scrotum, breast) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P |
| Cardiac Pediatric | P | P | P | P | P | P | P | |
| Trans-esoph. (Cardiac) | P | P | P | P | P | P | P | |
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Carotid, I/O) | ||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||
| *Other modes: Color Power Angio, Tissue Doppler Imaging, Directional Angio Imaging, | ||||||||
| Combined modes: Duplex = 2D + Doppler |
Previous submission: First use on this ultrasound system (See 4.4.1.4)
(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
Hose M. Whing
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
18
510(k) Number: System: Philips Ultrasound, Inc. HD15 Diagnostic Ultrasound System
Transducer: S8-3 Sector phased array transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track I Only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (Specify) | Other* | ||||||||
| (Specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | |||
| Abdominal | P | P | P | P | P | P | P | ||
| Intra-operative | |||||||||
| (vascular/epicardial) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal Imaging | |||||||||
| & Other | Pediatric | P | P | P | P | P | P | P | |
| Small Organ (thyroid, | |||||||||
| scrotum, breast) | |||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | ||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel (conventional) | |||||||||
| Musculo-skel (superficial) | |||||||||
| 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) | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | P | P | |
| Vessel | Other (Carotid, I/O) | ||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | |||||||||
| * Other modes: Color Power Angio, Panoramic, 3-D Imaging, Directional Angio Imaging, Tissue Doppler Imaging | |||||||||
| Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color |
Previous submission: First use on this ultrasound system (See 4.4.1.4)
(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)
Horge M. Whan
(Division Sidn-Off) Division of Reproductive, Abdominal, a Radiological Devices 510(k) Number
19
510(k) Number: K
System: Philips Ultrasound, Inc. Pathfinder Diagnostic Ultrasound System Transducer: V6-2 Mechanical 3D Transducer
| Clinical Application | | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation | | | | | | |
|---------------------------|------------------------------|-----------------------------------------------------------------------------------------------------------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General
(Track I Only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | Other*
(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
& Other | Pediatric | P | P | P | | P | P | P |
| | Small Organ (Scrotum, | | | | | | | |
| | Thyroid, Breast) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Gynecological) | P | P | P | | P | P | P |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (specify) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | |
| | Other (Carotid) | | | | | | | |
(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
VPrescription Use (Per 21 CFR 801.109)
Aonny M. Whing
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number