(15 days)
Not Found
No
The description mentions "advanced signal processing technologies" but does not explicitly mention AI, ML, or related terms like neural networks or deep learning. The focus is on standard ultrasound signal processing and equivalence to predicate devices.
No.
The device is clearly indicated for "Diagnostic ultrasound imaging or fluid flow analysis", and its description details its function in generating images for diagnosis, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". The "Device Description" also clearly identifies the device as a "diagnostic ultrasound device".
No
The device description explicitly states it consists of a system console, display screen, and transducers, which are hardware components. It describes the physical process of generating and receiving ultrasound waves.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is "Diagnostic ultrasound imaging or fluid flow analysis of the human body." This describes a device that interacts directly with the human body to produce images and analyze physiological processes in vivo.
- Device Description: The description details how the device generates and receives ultrasound waves to create images of internal tissues and analyze blood flow within the body.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue samples) outside of the body (in vitro) to provide information about a person's health. The description of this device does not mention the analysis of any such specimens.
Therefore, the HD11 ultrasound system is a diagnostic imaging device used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HD11 is intended for diagnostic ultrasound imaging and fluid flow analysis. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body.
Product codes (comma separated list FDA assigned to the subject device)
90IYN, 90IYO, 90ITX
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic
Anatomical Site
Ophthalmic, Fetal Imaging, Abdominal, Intra-operative (Epicardial/Vascular, Neuro), Laparoscopic, Pediatric, Small Organ (Thyroid, Scrotum, Breast), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esophageal (non-Cardiac), Intra-luminal, Gynecological, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac), Fetal Heart, Peripheral vessel, Carotid, Musculo-skeletal (conventional), Musculo-skeletal (superficial)
Indicated Patient Age Range
Adult, Pediatric, Neonatal, Fetal
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.
Philips M2540A EnVisor, HDI-5000 series Ultrasound systems
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.
K030455, K014191, K971116, K022303, K034003
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
K0435535
JAN - 6 2005
Summary of Safety and Effectiveness 3.2
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 Submissions Manager Philips Ultrasound MS 0135 3000 Minuteman Road Andover, MA 01810 Tel: (978) 659-2101 Fax: (978) 975-7324
This summary was prepared on November 12, 2004.
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.
The 3D8-4 and L15-7io transducers are substantially equivalent to other Philips sector, linear and endo-cavity ultrasound transducers.
1
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 ବି 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.
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 lines forming its body and wing. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 6 2005
Philips Ultrasound % Ms. Laura Danielson Responsible Third Party Official TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891
Re: K043535
Trade Name: HD11 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: December 11, 2004 Received: December 22, 2004
Dear Ms. Danielson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boouse as substantially equivalentially 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 Interstate continered problem to may 20, 1978, etc. ssified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to I cloudi i ood, Drug, and Cooments Free Act. The general controls provisions of the Act include the general controls provisions of and listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for I ins determination of substainter equirantee applied in your premarket notification:
Transducer Model Number
S3-1 (21711A) Sector Transducer S4-2 (989605344981) Sector Transducer PA 4-2 (21422A) Sector Transducer
3
S8-3 (21750A) Sector Transducer S12-4 (21780A) Sector Transducer T6H (21378A) Omni III Transesophagel Transducer S7-2omni (21778A) Omni III Sector Transducer S7-3t (21781A) Minimulti Sector Transducer D2cwc (4000-0947-01) 1.9 MHz non-imaging Pencil Probe D5cwc (4000-0950-01) 5.0 MHZ non-imaging Pencil Probe D2tcd (8500-1860-01) 2.0 MHz non-imaging Pencil Probe C8-5 (8500-1664-01) Curved Linear Transducer C5-2 (21426A) Curved Linear Transducer C9-4 (8500-1658-01) Curved Linear Transducer C8-4y (21437A) Curved Linear Transducer C9-5ec (8500-1655-01) Endocavity Transducer L12-5 (8500-1660-01) Linear Transducer L12-3 (21475A0 Linear Transducer L8-4 (8500-1659-01) Linear Transducer L15-7io (989605341571) Linear Intra-operative Transducer 3D8-4 (989605345331) Curved Linear Transducer 3D6-2 (8500-2023-01) Curved Linear Transducer 3D9-3V (8500-1715-01) Curved Linear Transducer
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.
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:
4
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 (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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David A. Logeman
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
5
Indications for Use Tables 4.3.2
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
510(k) Number: K
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 | ||||||||
| (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 Imaging | ||||||||
| & Other | Fetal | N | N | N | N | N | N | N |
| Abdominal | N | N | N | N | N | N | N | |
| Intra-operative | ||||||||
| (Epicardial/Vascular) | 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 | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | N |
| Other (Carotid, I/O) | 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 |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
*Other modes: Angio, Panoranics (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: None
(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
Daniel A. Seymour
(Division Sign-Off) Division of Reproductive, Abdominal ano Radiological Devices 5) Yk) Number ____
6
510(k) Number: K
System: Philips Ultrasound HD11 Diagnostic Ultrasound System
S3-1 (21711A) Sector 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 | N | N | N | N | N | N | N | |
| Abdominal | N | N | N | N | N | N | N | |
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | N | N | N | N | N | N | N |
| Small Organ (Scrotum, | ||||||||
| Thyroid, Breast) | ||||||||
| 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) | ||||||||
| 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 | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Carotid) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) |
new indication; P= previously cleared by FDA; E= added under Appendix E
*Other modes: X-Res, Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Freehand Imaging, Directional Angio Imaging, Tissue Doppler Imaging, Color Power Angio
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual
Previous submission: Cleared in K030455
(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
David A. Bergman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
7
510(k) Number: K
System: Philips Ultrasound HD11 Diagnostic Ultrasound System
S4-2 (989605344981) Sector 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 | 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 | ||||||||
| & Other | Pediatric | N | N | N | N | N | N | N |
| Small Organ (Scrotum, | ||||||||
| Thyroid, Breast) | ||||||||
| 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) GYN | 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 | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | N |
| Other (Carotid) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
*Other modes: X Res, Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging, Tissue Doppler Imaging
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual
Previous submission: Cleared as PA4-2 in K014191
(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
Daniel R. Seymore
(Division Sign-Off) Circision of Reproductive, Abdon and Radiological Devices 510(k) Number ___
8
510(k) Number: K
System: Philips Ultrasound HD11 Diagnostic Ultrasound System
PA 4-2 (21422A) Sector transducer Transducer:
I ransuacer .
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 (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | N | N | N | N | N | N | N |
| Small Organ (Scrotum, | ||||||||
| Thyroid, Breast) | ||||||||
| 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 | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Carotid) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) | ||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E |
11 Thew Indication, 1 - provider, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging, Tissue Doppler Imaging
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual
Previous submission: K014191
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (1 BE. 101 De 1 Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
David A. Leyson
:
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 5 PORQ Number ________________________________________________________________________________________________________________________________________________________________
9
510(k) Number: K
System: Philips Ultrasound HD11 Diagnostic Ultrasound System
Transducer: S8-3 (21750A) Sector 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 | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | N | |
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | N | N | N | N | N | N | N |
| Small Organ (Scrotum, | ||||||||
| Thyroid, Breast) | ||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | |
| Adult Cephalic | ||||||||
| 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 (Fetal Heart) | N | N | N | N | N | N | N | |
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | N |
| Other (Carotid) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) |
iously cleared by FDA; E= added under Appendix E
*Other modes: X-res, Angio, Panoramic, 3-D Imaging, Directional Angio Imaging, Tissue Doppler Imaging, Color Power Angio
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual
Previous submission: Cleared as s8 (21350A) in K014191
(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
David A. Larson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
10
510(k) Number: K
System: Philips Ultrasound HD11 Diagnostic Ultrasound System
S12-4 (21780A) Sector 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 Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Cardiac) | N | N | N | N | N | N | N | |
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | N | N | N | N | N | N | N |
| Small Organ (Scrotum, | ||||||||
| Thyroid, Breast) | ||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N |
| Cardiac Pediatric | N | N | N | N | N | N | N | |
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | N |
| Other (Carotid) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
*Other modes: X-Res, Angio, Panoramic, 3-D Inaging, Directional Angio Imaging, Tissue Doppler Imaging, Color Power Angio
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual
Previous submission: Cleared as s12 (21380A) in K014191, K971116
(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
Daniel A. Lyons
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
11
510(k) Number: K
System: Philips Ultrasound HD11 Diagnostic Ultrasound System T6H (21378A) Omni III Transesophagel 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 (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | |||||||
| Small Organ (Scrotum, | ||||||||
| Thyroid, Breast) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | ||||||||
| 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) | ||||||||
| Peripheral | ||||||||
| 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: X-Res, Angio, , Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging, Tissue Doppler Imaging
Combined modes: Duplex = 2D + Doppler, Triplex = 2D + Doppler + Color, Dual
Previous submission: K014191, K022303
(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
David R. Lyson
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdomina and Radiningical Devices 5 FO(k) Nomber __
12
510(k) Number: K
System: Philips Ultrasound HD11 Diagnostic Ultrasound System
S7-2omni (21778A) Omni III Sector transducer Transducer:
I ransuler : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| Specific | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| General | ||||||||
| (Track I Only) | (Tracks I & III) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | |||||||
| Small Organ (Scrotum, | ||||||||
| Thyroid, Breast) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | ||||||||
| 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) | ||||||||
| Peripheral | ||||||||
| 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: X-Res, Angio, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging, Tissue Doppler Imaging, Dual, Color Power Angio
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual
Previous submission: Cleared as 21378A in K022303
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (1 ESABE DO FOT WEBS and Radiological Health, Office of Device Evaluation
Daniel A. Jessop
(Division Sign-Off) Division of Reproductive, A and Radiological Devices 519(k) Number __
13
510(k) Number: K
System: Philips Ultrasound HD11 Diagnostic Ultrasound System
Transducer: S7-3t (21781A) Minimulti Sector 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 (Specify) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Fetal Imaging | ||||||||||
| & Other | Pediatric | |||||||||
| Small Organ (Scrotum, | ||||||||||
| Thyroid, Breast) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Intra-luminal | ||||||||||
| Other (Gynecological) | ||||||||||
| 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) | ||||||||||
| Peripheral | ||||||||||
| 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: X-Res, Angio, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging, Tissue Doppler | ||||||||||
| Imaging, Color Power Angio. |
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual
Previous submission: None
(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
Daniel A. Seymour
(Division Sign-Off) Division of Reproductive, Abdominal and Pachological Device bil grammamber __
14
510(k) Number: K
System: Philips Ultrasound HD11 Diagnostic Ultrasound System
D2cwc (4000-0947-01) 1.9MHz non-imaging Pencil Probe Transducer:
I ransuded 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 (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | |||||||
| Small Organ (Scrotum, | ||||||||
| Thyroid, Breast) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac Adult | N | |||||||
| Cardiac | Cardiac Pediatric | N | ||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| 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: None | ||||||||
| Combined modes: None | ||||||||
| Previous submission: Cleared as 21221B in K014191 |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (1 LEASE De of Center for Devices and Radiological Health, Office of Device Evaluation
Daniel A. Seymore
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
15
510(k) Number: K
System: Philips Ultrasound HD11 Diagnostic Ultrasound System
Transducer: D5cwc (4000-0950-01) 5.0 MHz non-imaging Pencil Probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: rate
| Clinical Application | | Mode of Operation | | | | | | Other*
(Specify) | |
|---------------------------|----------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|--|
| General
(Track I Only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging
& Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Scrotum,
Thyroid, Breast) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal · | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (Gynecological) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | N | N | | | | |
| | Other (Carotid) | | | | | | | | |
| | 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: Cleared as 21223B in K014191 | | | | | | | | |
(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
Daniel A. Swanson
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number ___
16
510(k) Number: K
System: Philips Ultrasound HD11 Diagnostic Ultrasound System
D2tcd (8500-1860-01) 2.0MHz non-imaging Pencil Probe 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 (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | |||||||
| Small Organ (Scrotum, | ||||||||
| Thyroid, Breast) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | N | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | ||||||
| Other (Carotid) | ||||||||
| 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: Cleared as D2TC in K030455
(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
David R. Ingram
(Division Sign-Off) Division of Reproductive, A and Radiological Devices 51 are spinner ___
17
510(k) Number: K
System: Philips Ultrasound HD11 Diagnostic Ultrasound System
Transducer: C8-5 (8500-1664-01) 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 | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | N | N | N | N | N | N | |
| Small Organ (Scrotum, | ||||||||
| Thyroid, Breast) | ||||||||
| Neonatal Cephalic | N | N | N | N | N | N | ||
| 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 (Fetal) | N | N | N | N | N | N | ||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | |
| 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, 3-D Imaging, Directional Angio Imaging, iSCAN, Doppler/2D, Color Power Angio
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual
Previous submission: Cleared on K030455
(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
David A. Hyman
(Division Sign-Off) Division of Reproductive, Ab and adiological Device 与:Number___
18
510(k) Number: K
System: Philips Ultrasound HD11 Diagnostic Ultrasound System
C5-2 (21426A) Curved Linear 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 | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | N | N | N | N | N | N | |
| Small Organ (Scrotum, | ||||||||
| Thyroid, 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 | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | |
| 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
Previous submission: K014191
(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
Daniel A. Layson
(Division Sign-Off) Division of Reproductive, Abo and Radiological Devices 510(k) Number _
19
510(k) Number: K
System: Philips Ultrasound HD11 Diagnostic Ultrasound System
Transducer: C9-4 (8500-1658-01) 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 | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | N | N | N | N | N | N | |
| Small Organ (Scrotum, | ||||||||
| Thyroid, Breast) | ||||||||
| 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 (Fetal) | N | N | N | N | N | N | ||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | |
| Other (Carotid) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) |
indication; P= previously cleared by FDA; E= added under Appendix E
*Other modes: SonoCT, X-Res, Angio, Panoramic, 3-D Imaging, Directional Angio Imaging, Color Power Angio Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual
Previous submission: Cleared on K030455
(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
David H. Lyman
(Division Sign-Off)4 Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
20
510(k) Number: K
System: Philips Ultrasound HDI Diagnostic Ultrasound System
C8-4v (21437A) Curved Linear Transducer Transducer:
I l'allsuded 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 | N | N | N | N | N | N | |
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Scrotum, | ||||||||
| Thyroid, Breast) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | N | N | N | N | N | N | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| 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, 3-D Imaging, Directional Angio Imaging, Color Power Angio | ||||||||
| Combined modes: Duplex = 2D + Doppler Triplex = 2D + Doppler + Color, Dual |
Previous submission: K014191
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (1 EE210E DO FOT WEES and Radiological Health, Office of Device Evaluation
David A. Legron
(Division Sign-Off) Division of Reproductive, Abd and Radiological Devices 51(X) Number _
21
510(k) Number: K
System: Philips Ultrasound HDI I Diagnostic Ultrasound System
Transducer: C9-5ec (8500-1655-01) 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 | N | N | N | N | N | N | ||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | |||||||
| Small Organ (Scrotum, | ||||||||
| Thyroid, Breast) | ||||||||
| 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) | N | N | N | N | N | N | ||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| 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, 3-D freehand Imaging, Directional Angio Imaging, Color Power Angio | ||||||||
| Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual | ||||||||
| Previous submission: Cleared on K030455 |
(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
David R. Lawson
(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number
22
510(k) Number: K
System: Philips Ultrasound HD11 Diagnostic Ultrasound System
L12-5 (8500-1660-01) Linear Transducer Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Intended Use: Diagnostic ultrasound imaging | ||||||||
|---|---|---|---|---|---|---|---|---|
| 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 | N | N | N | N | N | N | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | N | N | N | N | N | N | |
| Small Organ (Scrotum, | ||||||||
| Thyroid, 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) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | |
| Other (Carotid) | N | N | N | N | N | N | ||
| Musculo-skel (conventional) | N | N | N | N | N | N | ||
| Musculo-skel (superficial) | N | N | N | N | N | N |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
*Other modes: SonoCT, X-Res, Angio, Panoramic, 3-D Imaging, Directional Angio Imaging, IMT measures, Color Power Angio
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual
Previous submission: Cleared in K030455
(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
David Lehman
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number _
23
510(k) Number: K
System: Philips Ultrasound HD11 Diagnostic Ultrasound System
L12-3 (21475A) Linear Transducer Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| Specific | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) | |
| General | ||||||||
| (Track I Only) | (Tracks I & III) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | N | N | N | N | N | N | |
| Small Organ (Scrotum, | ||||||||
| Thyroid, 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) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | |
| Other (Carotid) | N | N | N | N | N | N | ||
| Musculo-skel (conventional) | N | N | N | N | N | N | ||
| Musculo-skel (superficial) | N | N | N | N | N | N | ||
| 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, IMT Measures, Color Power Angio | ||||||||
| Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual |
Previous submission: K014191
(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. Lehman
1
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
24
510(k) Number: K
System: Philips Ultrasound HD11 Diagnostic Ultrasound System
Transducer: L8-4 (8500-1659-01) Liner 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 | N | N | N | N | N | N | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | N | N | N | N | N | N | |
| Small Organ (Scrotum, | ||||||||
| Thyroid, 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) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | |
| Other (Carotid) | N | N | N | N | N | N | ||
| Musculo-skel (conventional) | N | N | N | N | N | N | ||
| Musculo-skel (superficial) | N | N | N | N | N | N |
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, IMT, Color Power Angio
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual
Previous submission: Cleared on K030455
(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
David R. Larson
(Division Sign-Off) Division of Reproductive. and Radiological Device 510(k) Number _
25
510(k) Number: K
System: Philips Ultrasound HDI 1 Diagnostic Ultrasound System
L15-7io (989605341571) Linear Intra-operative 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 Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Cardiac, | ||||||||
| Vascular) | N | N | N | N | N | N | ||
| Intra-operative (Neuro) | N | N | N | N | N | N | ||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | ||
| Small Organ (Scrotum, | ||||||||
| Thyroid, 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) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | |
| Other (I/O) | N | N | N | N | N | N | ||
| Musculo-skel (conventional) | N | N | N | N | N | N | ||
| Musculo-skel (superficial) | N | N | N | N | N | N | ||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||
| *Other modes: SonoCT, X-Res, Angio, Panoramic, 3-D Imaging, Directional Angio Imaging, | ||||||||
| Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual | ||||||||
| Previous submission: Cleared K030455 |
(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
David h. Leppan
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number .
26
510(k) Number: K
System: Philips Ultrasound HDI Diagnostic Ultrasound System
3D8-4 (989605345331) Curved Linear Transducer Transducer:
I l'ansuucer. - - - JDG - (7070055 15603) in the how 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 | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | N | N | N | N | N | N | |
| Small Organ (Scrotum, | ||||||||
| Thyroid, Breast) | ||||||||
| 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 (Fetal Heart ) | N | N | N | N | N | N | ||
| Peripheral | ||||||||
| 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
real Tical (opatial Temporal Intego Colex Triplex = 2D + Doppler + Color, Real Time Biopsy, Dual
Previous submission: None
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (I EEAOL DO NOT 171215 Devices and Radiological Health, Office of Device Evaluation
David R. Hanson
(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number _
27
510(k) Number: K
System: Philips Ultrasound HD11 Diagnostic Ultrasound System
Transducer: 3D6-2 (8500-2032-01) Curved Linear Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Cliniani A
| 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 | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | N | N | N | N | N | N | |
| Small Organ (Scrotum, | ||||||||
| Thyroid, Breast) | ||||||||
| 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 (Fetal Heart) | N | N | N | N | N | N | ||
| Peripheral | ||||||||
| 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 on 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. Johnson
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number
28
| 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 | Combined | Other * |
| (Track I Only) | (Tracks I & III) | Doppler | (Specify) | (Specify) | ||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | N | N | N | N | N | ||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | Pediatric | |||||||
| & Other | Small Organ (Scrotum, | |||||||
| Thyroid, Breast) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | N | N | N | N | N | N | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | N | N | N | N | N | N | ||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Fetal Heart ) | N | N | N | N | N | N | ||
| Peripheral | Peripheral vessel | |||||||
| 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 |
(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
David A. Seymann
(Division Sign-Off) Division of Reproductive, Abdon and Radiological Devices 51(){k) Number _