(17 days)
Not Found
No
The document describes standard ultrasound technology and signal processing, with no mention of AI, ML, or related concepts.
No
The device is described as a "diagnostic ultrasound device" intended for "ultrasound imaging or fluid flow analysis," which are diagnostic rather than therapeutic functions.
Yes
The "Intended Use / Indications for Use" states "Diagnostic ultrasound imaging or fluid flow analysis of the human body," and the "Device Description" explicitly calls it a "diagnostic ultrasound device."
No
The device description explicitly states it consists of a system console, display screen, and transducers, which are hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The description clearly states that this device is used for "Diagnostic ultrasound imaging or fluid flow analysis of the human body." It directly interacts with the patient's body to generate images and analyze fluid flow within the body, not to test samples taken from the body.
- The mechanism of action is ultrasound. The device uses ultrasonic waves transmitted into the body and reflected back to create images. This is a physical imaging modality, not a chemical or biological test performed on a sample.
- The intended use is diagnostic imaging and fluid flow analysis. These are typical applications for ultrasound devices used for visualizing internal structures and blood flow, not for analyzing the composition or characteristics of biological samples.
In summary, this device is a diagnostic imaging device that uses ultrasound to visualize and analyze structures and fluid flow within the human body. This falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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 M2540 is a diagnostic ultrasound device. It consists of a system console containing the power supply and electronic circuitry required to generate the image, a display screen, and a connection to the separate transducers. 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), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (thyroid, scrotum, breast, prostate), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Intra-luminal, Gynecological, Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Pelvic, Peripheral vessel, Musculo-skeletal (conventional), Musculo-skeletal (superficial).
Indicated Patient Age Range
Adult, Pediatric, Fetal, Neonatal
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.
Not Found
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.
K002470, K990400, K990339, K980687, K972348, K954028, K971116, K001711, K990330
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
JAN 0 7 2002
3.2 Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 as implemented in 21 C.F.R. §807.92.
The submitter of this premarket notification is:
Steve Singlar Regulatory Engineer Philips Medical Systems Philips Ultrasound Division 3000 Minuteman Road, MS 0135 Andover, MA 01810 Tel: (978) 659-2101 Fax: (978) 975-7324
This summary was prepared on November 19, 2001.
The proprietary name of the device is the M2540 Diagnostic Ultrasound System. In combination with the new transducers - 21373B, 21422A, 21426A, 21475A - are commonly known as a diagnostic ultrasound system and transducers.
These devices are classified as follows:
| 90IYN | Ultrasonic Pulsed Doppler Imaging System |
|---|---|
| 90IYO | Ultrasonic Pulsed Echo Imaging System |
| 90ITX | Diagnostic Ultrasound Transducer |
As stated in 21 CFR, parts 892.1550, 892.1560 and 892.1570, each of these generic types of devices have been classified as Class II.
The M2540 is a diagnostic ultrasound device. It consists of a system console containing the power supply and electronic circuitry required to generate the image, a display screen, and a connection to the separate transducers. It is substantially equivalent to the ultrasound systems including the M2410 Ultrasound system with transducers.
The 21422A. 21425A. 21446A. 21475A transducers are substantially equivalent to the Philips sector, linear and endo-cavity ultrasound transducers.
1
The M2540 system and transducers function in a manner identical to all ultrasound systems and transducers. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo-electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The differing acoustic properties of the tissues in the body reflect some of the transmitted energy back to the transducer, where it is converted back to electrical signals and sent back to the system. In the system, advanced signal processing technologies convert the returned signals into images of the tissues. The Doppler functions of this system process the Doppler shift frequencies from the echoes of moving targets (such as blood), to detect and graphically display the Doppler shifts of these tissues as flow.
The M2540 is intended for diagnostic ultrasound imaging and fluid flow analysis.
The M2540 is substantially equivalent in safety and effectiveness to the predicates identified above:
- Both the predicate device and the M2540 are indicated for the diagnostic ultrasonic imaging ● and fluid flow analysis.
- Both the predicate device and the M2540 have the same gray-scale and Doppler capabilities. .
- Both the predicate device and the M2540 use essentially the same technologies for imaging, ● Doppler functions and signal processing.
- Both the predicate device and the M2540 have acoustic output levels below the Track 3 . FDA limits.
- Both the predicate device and the M2540 are manufactured under equivalent quality systems. .
- . Both the predicate device and the M2540 are manufactured of materials with equivalent biosafety. The materials have been evaluated and found to be safe for this application.
- Both the predicate device and M2540 are designed and manufactured to the same electrical . and physical safety standards.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three parallel lines that curve to form the shape of a head and shoulders. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 7 2002
Phillips Medical Systems % Mr. Mark Job 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891
Re: K014191
Trade Name: M2540 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasound pulsed doppler imaging system Regulatory Class: II Product Code: 90 IYN Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYO Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 ITX Dated: December 20, 2001 Received: December 21, 2001
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the M2540 Diagnostic Ultrasound System, as described in your premarket notification:
3
Transducer Model Number
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
4
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Robert A Phillips at (301) 594-1212.
Sincerely yours.
Nancy C brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
5
Indications for Use Tables 4.3.2
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
510(k) number: K_014 |91
Device name: Philips Medical Systems M2540 Diagnostic Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (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 | ||||||||
| (vascular/epicardial) | N | N | N | N | N | N | N | |
| Intra-operative (Neuro) | N | N | N | N | N | N | N | |
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | N | |
| Small Organ (thyroid, scrotum, breast) | N | N | N | N | N | N | N | |
| Neonatal Cephalic | N | N | N | N | N | N | N | |
| Adult Cephalic | N | N | N | N | N | N | N | |
| Trans-rectal | N | N | N | N | N | N | N | |
| Trans-vaginal | N | N | N | N | N | N | N | |
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | N | N | N | N | N | N | N | |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N |
| Cardiac Pediatric | N | N | N | N | N | N | N | |
| Trans-esoph. (Cardiac) | N | N | N | N | N | N | N | |
| Other (Fetal) | N | N | N | N | N | N | N | |
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | N |
| Other (Specify) | ||||||||
| Musculo-skel (conventional) | N | N | N | N | N | N | N | |
| Musculo-skel (superficial) | N | N | N | N | N | N | N |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
- Other modes: Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging, Doppler Tissue Imaging
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color NO previous 510(k) submissions are associated with this product.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Nancy C. Hergdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K014191
510(k) Number
RA
6
510(k) Number: K
Philips Medical Systems M2540 Diagnostic Ultrasound System System:
Transducer: 21221B (C1914C) Non-Imaging Pencil transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Other* (Specify) | ||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | (Specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | |||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | N | |||||||
| Cardiac | Cardiac Pediatric | N | ||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) | ||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||
| *Other modes include: None | ||||||||
| Combined modes: None. | ||||||||
| Previous submission: K002470. Adult & Pediatric cardiac |
.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Nancy C. Broadion
(Division Sign-Ofm
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K014191
7
510(k) Number: K
Philips Medical Systems M2540 Diagnostic Ultrasound System System: Transducer: 21223B (D5014V) Non-Imaging Pencil transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Fetal Imaging | ||||||||
| & Other | Intra-operative (Specify) | |||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | |||||
| Other (Specify) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) | ||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||
| *Other modes: None | ||||||||
| Combined modes: None |
Previous submission: K002470, Peripheral vascular
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
:
MauricShridon
8
510(k) Number: K
Philips Medical Systems M2540 Diagnostic Ultrasound System System:
Transducer: 21228B (D1914V) Non-imaging pencil transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (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 (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | N | N | ||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | ||||||
| Other (Specify) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
| *Other modes: | None |
|---|---|
| Combined modes: | None |
| Previous submission: | K002470 for Peripheral vascular |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
Nancy Chrzdon
510(k) Num
9
510(k) Number: K
Philips Medical Systems M2540 Diagnostic Ultrasound System System:
Transducer: 21321A (C3540) Curved linear array transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (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 (thyroid, | ||||||||
| scrotum, breast) | N | N | N | N | N | N | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (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 (Specify) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E *Other modes: Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color Previous submission: K002470 for fetal, abdominal and PV; K990400 for fetal, pediatic, abdominal, small parts and PV
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Ylancy C. Hugdon
(Division St and Radiolo 510(k) Numb
10
510(k) Number: K
Philips Medical Systems M2540 Diagnostic Ultrasound System System:
Transducer: 21330A (S4) Sector transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (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 (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | N | N | N | N | N | N | N | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | N | N | N | N | N | N | N | |
| Cardiac Adult | N | N | N | N | N | N | N | |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | N | N |
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | N |
| Other (Specify) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
*Other modes: Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging, Doppler Tissue Imaging
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color
Previous submission: K002470 for Abdominal, Adult Cephalic, Cardiac, PV, Fetal and Ophthalmic; K990400 for Abdominal, Adult cephalic, Adult Cardiac; K990339 for Abdominal, Adult cephalic, Cardiac, Fetal and Ophthalmic; K980687 for Abdominal, Adult Cephalic, Fetal, Adult Cardiac, Ophthalmic and Harmonic Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Nancy Croglon
Sign-Off
(Division Sign-Off Division of Reproductive, Abdomin and Radiological Devices 510(k) Number _
11
510(k) Number: K
Philips Medical Systems M2540 Diagnostic Ultrasound System System:
Transducer: 21336A (E6509) Endocavity transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (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 (Prostate) | N | N | N | N | N | N | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | N | N | N | N | N | N | |||
| Trans-vaginal | N | N | N | N | N | N | |||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Intra-luminal | |||||||||
| Other (Gynecological) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (Specify) | |||||||||
| Musculo-skel (conventional) | |||||||||
| Musculo-skel (superficial) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
*Other modes: Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging, Doppler Tissue Imaging
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color
Previous submission: K990339 for Fetal, Endorectal, Endovaginal, Small Parts; K972348 Endovaginal, Endorectal, Gynecological, Obstetrics, Urological
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Vancie Scizdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K014191
12
510(k) Number: K
Philips Medical Systems M2540 Diagnostic Ultrasound System System:
Transducer: 21350A (S8) Sector transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (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 (Specify) | ||||||||
| Neonatal Cephalic | N | N | N | N | N | N | ||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Pelvic) | N | N | N | N | N | N | N | |
| Cardiac Adult | N | N | N | N | N | N | ||
| Cardiac | Cardiac Pediatric | N | N. | N | N | N | N | N |
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | |
| Vessel | Other (Specify) | |||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
*Other modes: Angio, Panoramic, 3-D Imaging, Directional Angio Imaging, Doppler Tissue Imaging Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color
Previous submission: K002470 for abdominal, adult & pediatric cardiac
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
13
510(k) Number: K
Philips Medical Systems M2540 Diagnostic Ultrasound System System:
Transducer: 21359A (L7535) Linear array transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | N | N | N | N | N | N | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | ||
| Small Organ (thyroid, scrotum, breast) | N | N | N | N | N | N | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | |
| Other (Specify) | ||||||||
| Musculo-skel (conventional) | N | N | N | N | N | N | ||
| Musculo-skel (superficial) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
*Other modes: Angio, Panoramic, 3-D Imaging, Directional Angio Imaging
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color
Previous submission: K954028 for PV, Pediatrics, Abdominal, Small Parts, and Musculo-skeletal (conventional)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Nancy C. Scagdon
(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
14
510(k) Number: K
Philips Medical Systems M2540 Diagnostic Ultrasound System System:
Transducer: 21360A (L5035) Linear array transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (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 (thyroid, | ||||||||
| scrotum, breast) | N | N | N | N | N | N | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | |
| Other (Specify) | ||||||||
| Musculo-skel (conventional) | N | N | N | N | N | N | ||
| Musculo-skel (superficial) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
*Other modes: Angio, Panoramic, 3-D Imaging, Directional Angio Imaging
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color
Previous submission: K954028 for Vascular, Pediatrics, Musculo-Skeletal (conventional) and Abdominal.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdor and Radiological Devices 510(k) Number _
15
510(k) Number: K
Philips Medical Systems M2540 Diagnostic Ultrasound System System:
Transducer: 21369A (Omni II) TEE Sector transducer
I ransuccer. - 21.0071 (Outrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (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 (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Intra-luminal | |||||||||
| Other (Specify) | |||||||||
| Cardiac Adult | N | N | N | N | N | N | |||
| Cardiac | Cardiac Pediatric | N | N | N | N | N | N | ||
| Trans-esoph. (Cardiac) | N | N | N | N | N | N | N | ||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (Specify) | |||||||||
| Musculo-skel (conventional) | |||||||||
| Musculo-skel (superficial) | |||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | |||||||||
| *Other modes: Angio, Doppler Tissue Imaging, Directional Angio |
Combined modes: Duplex = 2D + Doppler
Previous submission: K954028 for Adult & pediatric cardiac, transesophageal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
:
Nancy brondon
(Division Sign-Off) Division of Reproductive, and Radiological Devices 51 (Xk) Number -
16
510(k) Number: K
Philips Medical Systems M2540 Diagnostic Ultrasound System System:
Transducer: 21373A (C5040) Curved Linear array transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (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 (Specify) | ||||||||
| 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 (Specify) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) | ||||||||
| N= new indication: P= previously cleared by FDA: E= added under Appendix E |
*Other modes: Angio, Panoramic, 3-D Imaging, Directional Angio Imaging
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color
Previous submission: (K954028) for Fetal, Small Parts, Abdominal, Neonatal Cephalic, Cardiac and Vascular.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Nancy Hugdon
(Division Sign-Off)
Division of Reproductive, Abdominal
Division of Reproductive, Abdomina and Radiological Devices 510/k) Number ................................................................................................................................................................
17
510(k) Number: K
Philips Medical Systems M2540 Diagnostic Ultrasound System System:
Transducer: 21373B (C5040) Curved Linear array transducer
I raustucer : 21373B (C5940) Curved Einear and your analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| General | ||||||||
| (Track I Only) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | ||
| Fetal Imaging | ||||||||
| & Other | Small Organ (Specify) | |||||||
| 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 (Specify) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) |
N= new indication; P= previously cleared by FDA; E= added under Appen *Other modes: Angio, Panoramic, 3-D Imaging, Directional Angio Imaging
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color
Comother modes. Duplex - 2D + Dopper, Triplex - 2D + Fetal, Small Parts, Abdominal, Neonatal Cephalic, Cardiac and Vascular.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEDED) (FLEASE DO NOT WATE BEBO N. IN Radiological Health, Office of Device Evaluation
Nancye Brogdon
IDivision Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 5100k) Number ................................................................................................................................................................
18
510(k) Number: K
Philips Medical Systems M2540 Diagnostic Ultrasound System System:
Transducer: 21376A (L1038) 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 | |||||||
| Abdominal | N | N | N | N | N | N | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| 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 (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | |
| Other (Specify) | ||||||||
| 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: Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging, Doppler Tissue Imaging.
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color
Previous submission: K990400 for Small parts, Peripheral Vascular and Musculo-skeletal (Conventional & Superficial).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
Nancy C. Cropton
(Division Sign-Off)
Division of Reproductive, Abdom ind Radiological Devices : 1000 Number ......
19
510(k) Number: K
Philips Medical Systems M2540 Diagnostic Ultrasound System System:
Transducer: 21380A (S12) 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 Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| ((vascular/epicardial) | N | N | N | N | N | N | ||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | N | |
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | |
| Cardiac Pediatric | N | N | N | N | N | N | ||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | N |
| Other (Specify) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
*Other modes: Angio, Panoramic, 3-D Imaging, Directional Angio Imaging, Doppler Tissue Imaging
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color
Previous submission: K971116 for Intraoperative (cardiovascular), Pediatric, Cardiac (Adult & Pediatric), Peripheral Vascular
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
519KI Number A12777
20
510(k) Number: K
Philips Medical Systems M2540 Diagnostic Ultrasound System System:
Transducer: 21390A (15-6l) 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 | ||||||||
| Intra-operative | ||||||||
| (vascular/epicardial) | N | N | N | N | N | N | ||
| Intra-operative (Neuro) | N | N | N | N | N | N | ||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | N | N | N | N | N | ||
| Small Organ (Thyroid) | N | N | N | N | N | N | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | |
| Other (Specify) | ||||||||
| Musculo-skel (conventional) | N | N | N | N | N | N | ||
| Musculo-skel (superficial) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
*Other modes: Amplitude Doppler, Panoramic, Directional Angio Imaging
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color
Previous submission: K001711 for Intraoperative (cardiovascular & neurological), Small parts, Musculo-skeletal (conventional). K990330 for Intraoperative (Cardiovascular), Pediatric, Small Parts, Cardiac, Peripheral Vascular,
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evalua
Office of Device Evaluation
Danvil Chrogdon
(Division Sigh-Off) Division of Reproductive, Abdolttinat and Radiological Devices 5 : O(k) Number ______________________________________________________________________________________________________________________________________________________________
21
510(k) Number: K
Philips Medical Systems M2540 Diagnostic Ultrasound System System:
Transducer: 21422A Sector transducer
I Fallsuded 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 | N | N | N | N | N | N | ||
| Fetal | ાંત | N | N | N | N | N | |||
| Abdominal | ાર | N | N | N | N | N | ਨ | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal Imaging | Pediatric | N | N | N | N | N | N | N | |
| & Other | Small Organ (Specify) | ||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | N | N | N | N | N | N | N | ||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Intra-luminal | |||||||||
| Other (Gynecological) | |||||||||
| 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 | Peripheral vessel | ||||||||
| Vessel | Other (Specify) | ||||||||
| Musculo-skel (conventional) | |||||||||
| Musculo-skel (superficial) | |||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | |||||||||
| *Other modes: Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging | |||||||||
| Combined modes: Duplex = 2D + Doppler: Triplex = 2D + Doppler + Color |
Previous submission: None.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (TEEADDO NOT WIGTE BEBO () ad Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
Maurice Shrodon
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices · 1090 Number ............
22
510(k) Number: K
Philips Medical Systems M2540 Diagnostic Ultrasound System System:
Transducer: 21425A Curved linear array transducer
I Tallsuccer. " 214231 Curved mean arring or fluid flow analysis of the human body as follows:
| 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 | 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 (Specify) | ||||||||
| 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 | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Fetal) | N | N | N | N | N | N | ||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) | ||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||
| *Other modes: Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging |
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color
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
Maurice broglon
(Division Sigh-Off) (Envision Significan Abdomin and Padiological Devices 19 Nomber ... ................................................................................................................................................................
23
510(k) Number: K
Philips Medical Systems M2540 Diagnostic Ultrasound System System:
Transducer: 21446A 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 (Specify) | ||||||||
| 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 | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) | ||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||
| *Other modes: Angio, Panoramic, 3-D Imaging, Directional Angio Imaging |
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color
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
Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal.
and Radiological Devices 510/k) Number ________________________________________________________________________________________________________________________________________________________________