(28 days)
Diagnostic ultrasound imaging and fluid flow analysis of the human body as follows: Ophthalmic, Fetal/Obstetric, Abdominal, Intra-operative (vascular/epicardial), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (thyroid, scrotum, prostate, breast), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Intra-luminal, Other (Gynecological), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Other (Fetal), Peripheral vessel, Musculo-skel (conventional), Musculo-skel (superficial).
The HD7 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.
The provided document is a 510(k) premarket notification for the Philips HD7 Diagnostic Ultrasound System and its associated transducers. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for reporting performance metrics against specific acceptance criteria from a new clinical study. Therefore, much of the requested information regarding detailed study design, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness (MRMC) studies is not present in this document.
The document focuses on establishing equivalence based on:
- Intended Use: Both the predicate and the HD7 are indicated for diagnostic ultrasonic imaging and fluid flow analysis.
- Technological Characteristics: They have the same gray-scale and Doppler capabilities, use similar technologies for imaging, Doppler functions, and signal processing.
- Acoustic Output: Both have acoustic output levels below Track 3 FDA limits.
- Manufacturing and Biosafety: Both are manufactured under equivalent quality systems, of materials with equivalent biosafety, and designed/manufactured to the same electrical and physical safety standards.
The tables provided in sections {5}-{17} are "Indications for Use Forms" which describe the clinical applications and modes of operation for which the device and each transducer are indicated. They categorize indications as:
- N: New indication
- P: Previously cleared by FDA (referring to previous 510(k) clearances for the predicate device).
- E: Added under Appendix E (also referring to indications previously cleared, but specifically in an appendix related to extensions/modifications).
These tables are not performance reports, but rather statements of intended use within the scope of existing clearances.
Based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance metrics. The "performance" assessment is qualitative, stating that the HD7 system and transducers function in a manner identical to other Philips ultrasound systems and transducers and are substantially equivalent to the predicate device (M2540/EnVisor ultrasound systems, cleared in K014191) in terms of safety and effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functionality identical to established Philips ultrasound systems. | HD7 system and transducers function identically to all Philips ultrasound systems and transducers. |
| Substantial equivalence to predicate device (K014191). | HD7 is substantially equivalent in safety and effectiveness to predicates. This is supported by: - Identical intended use. - Same gray-scale and Doppler capabilities. - Essentially same technologies. - Acoustic output below Track 3 FDA limits. - Equivalent quality systems and biosafety materials. - Designed and manufactured to same electrical and physical safety standards. |
| Acoustic output levels below Track 3 FDA limits. | Acoustic output levels are below the Track 3 FDA limits. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) submission establishes substantial equivalence through comparison to a predicate device and engineering analysis, rather than new clinical performance data from a specific test set. No separate "test set" or data provenance information is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The document does not describe a clinical study requiring expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or expert adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-enabled device. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a diagnostic ultrasound system, not an algorithm, and its performance is inherently linked to human operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No new clinical performance study requiring a specific "ground truth" is reported in this summary. The basis for clearance is substantial equivalence to a predicate, which implies the predicate's established performance serves as the benchmark.
8. The sample size for the training set
Not applicable. No machine learning or AI component requiring a "training set" is described for this device.
9. How the ground truth for the training set was established
Not applicable. See point 8.
{0}------------------------------------------------
2080548
MAR 27 2008
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:
Nancy P. Burke Regulatory Specialist Philips Medical Systems 22100 Bothell Everett Highway Bothell, WA 98021-8431 Tel: (425) 487-7371 Fax: (425) 487-8666
This summary was prepared on February 15, 2008.
The proprietary name of the device is the HD7 Diagnostic Ultrasound System. In combination with transducers - L12-3, L12-5 50, 15-6L, S4-2, S8, C5-2, C6-3, C8-5, D5009V, E6509, C8-4V, T6H- 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 HD7 is a diagnostic ultrasound device. It consists of a system console containing the power supply and electronic circuitry required to generate the image, a display screen, and a connection to the separate transducers. It is substantially equivalent to the currently marketed M2540/EnVisor ultrasound systems and transducers cleared in K014191.
{1}------------------------------------------------
The HD7 system and transducers function in a manner identical to all Philips ultrasound systems and transducers. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo-electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The differing acoustic properties of the tissues in the body reflect some of the transmitted energy back to the transducer, where it is converted back to electrical signals and sent back to the system. In the system, advanced signal processing technologies convert the returned signals into images of the tissues. The Doppler functions of this system process the Doppler shift frequencies from the echoes of moving targets (such as blood), to detect and graphically display the Doppler shifts of these tissues as flow.
The HD7 is intended for diagnostic ultrasound imaging and fluid flow analysis.
The HD7 is substantially equivalent in safety and effectiveness to the predicates identified above:
- Both the predicate device and the HD7 are indicated for the diagnostic ultrasonic imaging . and fluid flow analysis.
- Both the predicate device and the HD7 have the same gray-scale and Doppler . capabilities.
- . Both the predicate device and the HD7 use essentially the same technologies for imaging. Doppler functions and signal processing.
- Both the predicate device and the HD7 have acoustic output levels below the Track 3 . FDA limits.
- Both the predicate device and the HD7 are manufactured under equivalent quality . systems.
- Both the predicate device and the HD7 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 HD7 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 an eagle or bird with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 2008
Philips Medical Systems % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K080548
Trade/Device Name: HD7 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: March 13, 2008 Received: March 14, 2008
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the HD7 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
21422A (S4-2) 21350A (S8) 21475A (L12-3) 989803002251 (L12-5 50)
21390A (15-6L) 21426A (C5-2) 989605352341 (C8-5) 989803002683 (C8-4v) 21336A (E6509) 989605359591 (C6-3) 21223B (D5009V) 21378A (T6H)
{3}------------------------------------------------
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:
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html
{4}------------------------------------------------
Page 3 – Mr. Mark Job
If you have any questions regarding the content of this letter, please contact Ms. Lauren Hefner at (240) 276-3666.
Sincerely yours,
Arge M. Mather
tr. Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{5}------------------------------------------------
4.3.2 Indications for Use Tables
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
510(k) Number: Device name: HD7 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 IOnly) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | N | N | N | N | N | N | N |
| Fetal/Obstetric | 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 | ||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatric | N | N | N | N | N | N | N |
| Small Organ (thyroid, scrotum,prostate, breast) | N | N | N | N | N | N | ||
| Neonatal Cephalic | N | N | N | N | N | N | ||
| Adult Cephalic | N | N | N | N | N | N | N | |
| 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 | N | |
| Cardiac Adult | N | N | N | N | N | N | N | |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | N | N |
| Trans-esoph. (Cardiac) | N | N | N | N | N | N | N | |
| Other (Fetal) | N | N | N | N | N | N | ||
| PeripheralVessel | Peripheral vessel | N | 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: Color Power Angio, 3-D Imaging, Panoramic, Harmonics (Tissue & Contrast), , Directional Angio Imaging, Tissue Doppler Imaging
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color Previous submission: No previous 510(k)s are associated with this product
Previous Submission: No previous stocks 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
Prescription Use (Per 21 CFR 801.109)
(Division Sign-O Division of Reproductive, Abdom and Radiological Dev 510(k) Number
{6}------------------------------------------------
| Clinical Application | General(Track IOnly) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) | |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | Ophthalmic | P | P | P | P | P | P | |||
| FetalImaging& Other | Fetal/Obstetric | P | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | P | |||
| Intra-operative(vascular/epicardial) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | P | |||
| Small Organ (thyroid, scrotum,prostate, breast) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | P | P | P | P | P | P | P | |||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Intra-luminal | ||||||||||
| Other (Gynecological) | P | P | P | P | P | P | P | |||
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P | ||
| Cardiac Pediatric | P | P | P | P | P | P | P | |||
| Trans-esoph. (Cardiac) | ||||||||||
| Other (Fetal) | ||||||||||
| PeripheralVessel | Peripheral vessel | E | E | E | E | E | E | E | ||
| Other (Specify) | ||||||||||
| Musculo-skel (conventional) | ||||||||||
| Musculo-skel (superficial) | ||||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||||
| *Other modes include: Color Power Angio, 3D, Panoramic, Harmonics, Directional Angio Imaging, TissueDoppler Imaging |
Combined modes:. Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color Previous submission: K014191 for Ophthalmic, Fetal, Abdominal, Pediatric, Adult Cephalic, Adult &
Pediatric Cardiac. K043535 for Gynecological, Peripheral Vessel.
(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)
Horyn Th Wh
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devic
510(k) Number.
{7}------------------------------------------------
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track IOnly) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetric | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | P | |
| Intra-operative(vascular/epicardial) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatric | P | P | P | P | P | P | P |
| Small Organ (thyroid, scrotum,prostate, breast) | ||||||||
| Neonatal Cephalic | P | P | P | P | P | P | ||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | P | P | P | P | P | P | P | |
| Cardiac Adult | P | P | P | P | P | P | P | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P |
| Trans-esoph. (Cardiac) | ||||||||
| Other (Fetal) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P | |
| Other (Specify) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (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)
hro Th Wh
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number _
{8}------------------------------------------------
| 510(k) Number: | System: HD7 Diagnostic Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | 21475A (L12-3) Linear ArrayTransducer | |||||||
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | Mode of Operation | |||||||
| General(Track IOnly) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetric | ||||||||
| Abdominal | P | P | P | P | P | P | ||
| Intra-operative(vascular/epicardial) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatric | P | P | P | P | P | P | |
| Small Organ (thyroid, scrotum,prostate, breast) | P | P | P | P | P | P | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Fetal) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P | |
| Other (Specify) | ||||||||
| Musculo-skel (conventional) | P | P | P | P | P | P | ||
| Musculo-skel (superficial) | P | P | P | P | P | P | ||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||
| *Other modes: Color Power Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio | ||||||||
| Imaging |
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color 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)
Anya M. Whig
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices
510(k) Number
{9}------------------------------------------------
510(k) Number:
System: HD7 Diagnostic Ultrasound System
Transducer: 989803002251 (L12-5 50) Linear Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track IOnly) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetric | ||||||||
| Abdominal | E | E | E | E | E | E | ||
| Intra-operative(vascular/epicardial) | E | E | E | E | E | E | ||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatric | P | P | P | P | P | P | |
| Small Organ (thyroid, scrotum,prostate, breast) | P | P | P | P | P | P | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Fetal) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P | |
| Other (Specify) | ||||||||
| Musculo-skel (conventional) | P | P | P | P | P | P | ||
| Musculo-skel (superficial) | P | P | P | P | P | P |
*Other modes: Color Power Angio, Panoramic, Directional Angio Imaging
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color
Previous submission: K991671 for Intraoperative (Abdominal and Vascular Small Parts,) Musculo-skeletal (conventional and Superficial), 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
Prescription Use (Per 21 CFR 801.109)
Homer In White
(Division Sign-Off) Division of Reproductive, Abdom
Radiological Devices
510(k) Number K080548
{10}------------------------------------------------
| 510(k) Number: | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| System: HD7 Diagnostic Ultrasound 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 | Specific | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) | |
| (Track IOnly) | (Tracks I & III) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal/Obstetric | |||||||||
| Abdominal | |||||||||
| Intra-operative(vascular/epicardial) | P | P | P | P | P | P | |||
| Intra-operative (Neuro) | P | P | P | P | P | P | |||
| Laparoscopic | |||||||||
| FetalImaging& Other | Pediatric | P | P | P | P | P | |||
| Small Organ (thyroid, scrotum,prostate, breast) | P | P | P | P | P | P | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Intra-luminal | |||||||||
| Other (Gynecological) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Other (Fetal) | |||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | ||||
| Other (Specify) | P | P | |||||||
| Musculo-skel (conventional) | P | P | P | P | P | P | |||
| Musculo-skel (superficial) | P | ||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | |||||||||
| *Other modes: Amplitude Doppler, Panoramic, Directional Angio Imaging | |||||||||
| Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color | |||||||||
| Previous submission: 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)
Lozano, Jr.
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number_
{11}------------------------------------------------
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track IOnly) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetric | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | ||
| Intra-operative(vascular/epicardial) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatric | P | P | P | P | P | P | |
| Small Organ (thyroid, scrotum,prostate, breast) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | P | P | P | P | P | P | ||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Fetal) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P | |
| Other (Specify) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) | ||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||
| *Other modes: Color Power Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio | ||||||||
| Imaging, iSCAN, Doppler/2D |
(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)
Lori h. Why
Director Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number
{12}------------------------------------------------
| 510(k) Number: | ||||||||
|---|---|---|---|---|---|---|---|---|
| System: HD7 Diagnostic Ultrasound System | ||||||||
| Transducer: | 989605352341 (C8-5) Curved Linear Transducer | |||||||
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | Mode of Operation | |||||||
| General | Specific | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) |
| (Track IOnly) | (Tracks I & III) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetric | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | ||
| Intra-operative(vascular/epicardial) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatric | P | P | P | P | P | P | |
| Small Organ (thyroid, scrotum,prostate, breast) | ||||||||
| Neonatal Cephalic | P | P | P | P | P | P | ||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | P | P | P | P | P | P | ||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Fetal) | P | P | P | P | P | P | ||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P | |
| Other (Specify) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) | ||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||
| *Other modes: Color Power Angio, Harmonics (Tissue), Directional Angio Imaging, Tissue Doppler Imaging | ||||||||
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual
Previous Submission: K043535
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
Arzuh Wh
(Div/sion Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number_
{13}------------------------------------------------
| 510(k) Number: | |
|---|---|
| System: HD7 Diagnostic Ultrasound System | |
| Transducer: | 989803002683 (C8-4v) Curved Linear Transducer |
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| Clinical Application | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) | |
| General (Track I Only) | |||||||
| Specific (Tracks I & III) | |||||||
| Ophthalmic | |||||||
| Ophthalmic | P | P | P | P | P | P | |
| Fetal/Obstetric | |||||||
| Abdominal | |||||||
| Intra-operative (vascular/epicardial) | |||||||
| Intra-operative (Neuro) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Fetal Imaging & Other | |||||||
| Small Organ (thyroid, scrotum, prostate, breast) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | P | P | P | P | P | P | |
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Intra-luminal | |||||||
| Other (Gynecological) | P | P | P | P | P | P | |
| Cardiac Adult | |||||||
| Cardiac | |||||||
| Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | |||||||
| Other (Fetal) | |||||||
| 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: SonoCT, X-Res, Color Power Angio, Panoramic, 3-D Imaging, Directional Angio Imaging | |
| Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual | |
| Previous submission: K043535 for Fetal, Trans-vaginal. K961459 for Fetal, Trans-vaginal, Gynecological. |
(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)
Arra In. 22
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number
{14}------------------------------------------------
| 510(k) Number: | ||||||||
|---|---|---|---|---|---|---|---|---|
| System: HD7 Diagnostic Ultrasound 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 IOnly) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetric | P | P | P | P | P | P | ||
| Abdominal | ||||||||
| Intra-operative(vascular/epicardial) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatric | |||||||
| Small Organ (thyroid, scrotum,prostate, breast) | P | P | P | P | P | P | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | P | P | ||
| Trans-vaginal | P | P | P | P | P | P | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Fetal) | ||||||||
| PeripheralVessel | 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: Color Power Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging, Tissue doppler Imaging
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color
Previous submission: 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)
Arzu h Zh
(Dision Sign-Off) Division of Reproductive, Abdominal and Radiological Devic
510(k) Number.
{15}------------------------------------------------
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| (Track IOnly) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetric | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | ||
| Intra-operative(vascular/epicardial) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatric | P | P | P | P | P | P | |
| Small Organ (thyroid, scrotum,prostate, breast) | P | P | P | P | P | P | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | P | P | P | P | P | P | ||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Fetal) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P | |
| Other (Specify) | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (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 Exaluation
Prescription Use (Per 21 CFR 801.109)
Tony H. Wils
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices
510(k) Number
{16}------------------------------------------------
| General(Track I Only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) | |
|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging& Other | Fetal/Obstetric | ||||||||
| Abdominal | |||||||||
| Intra-operative(vascular/epicardial) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (thyroid, scrotum,prostate, 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 (Fetal) | |||||||||
| PeripheralVessel | Peripheral vessel | P | P | ||||||
| Other (Specify) | |||||||||
| Musculo-skel (conventional) | |||||||||
| Musculo-skel (superficial) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA; E= added under Appendix E
*Other modes: Color Power Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging, iSCAN, Doppler/2D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evice Evice Evice Evice Evice
Prescription Use (Per 21 CFR 801.109)
logh h Wh
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number A,800548
{17}------------------------------------------------
| 510(k) Number: | System: HD7 Diagnostic Ultrasound System |
|---|---|
| Transducer: | 21378A (T6H) Omni III Transesophageal Transducer |
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track IOnly) | Specific(Tracks I & III) | B | M | PWD | CWD | Color Doppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging& Other | Fetal/Obstetric | |||||||
| Abdominal | ||||||||
| Intra-operative(vascular/epicardial) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (thyroid, scrotum,prostate, breast) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P |
| Cardiac Pediatric | P | P | P | P | P | P | P | |
| Trans-esoph. (Cardiac) | P | P | P | P | P | P | P | |
| Other (Fetal) | ||||||||
| PeripheralVessel | 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: Color Power Angio, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging,Tissue Doppler Imaging |
Tissue Doppler Imaging
Combined modes: 2D + Doppler; Triplex = 2D + Doppler + Color,
Previous submission: K043535 for adult, pediatric and transesophageal 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
Prescription Use (Per 21 CFR 801.109)
Arron Z. Zitz
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K02
§ 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.