(55 days)
The EKO 7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-esophageal (non-Cardiac, Cardiac), Muscular-Skeletal (conventional, superficial), Cardiac Adult, Cardiac Pediatric and Peripheral-vessel.
The EKO 7 is a dedicated cardiac purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, color Doppler imaging, power Doppler imaging, Harmonic imaging, PW spectral Doppler mode, CW spectral Doppler mode or as a combination of these modes. The EKO 7 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The EKO 7 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The provided text is a 510(k) Premarket Notification for the EKO 7 Diagnostic Ultrasound System. This document focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.
Therefore, the requested information about acceptance criteria, device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, and MRMC comparative effectiveness studies is not available in the provided text for the EKO 7 Diagnostic Ultrasound System itself.
The document primarily outlines:
- Device Description: The EKO 7 is a mobile, software-controlled diagnostic ultrasound system for cardiac purposes and other applications. It acquires and displays ultrasound data in various modes (B-mode, M-mode, Doppler, Harmonic imaging, etc.).
- Intended Uses: Diagnostic ultrasound imaging and fluid analysis of the human body for various clinical applications include Fetal, Abdominal, Pediatric, Small Organs, Adult Cephalic, Trans-esophageal, Muscular-Skeletal, Cardiac Adult, Cardiac Pediatric, and Peripheral-vessel.
- Technological Characteristics: The device is stated to be substantially equivalent to previously cleared ACCUVIX V20 and V10 systems.
- Safety Standards: The EKO 7 has been designed to meet several product safety standards (e.g., UL 60601-1, IEC60601-2-37, NEMA UD-2).
- Transducers: A list of transducers compatible with the EKO 7 system is provided, along with their respective cleared indications for use, indicating whether they are new ("N") or previously cleared ("P") for specific modes of operation and clinical applications.
Note on "P" and "N" in Transducer Tables:
The tables for each transducer (e.g., C1-4EC, L3-8, P2-4BA) indicate "N" for new indications and "P" for previously cleared indications. This "P" refers to whether that specific transducer model had its indications cleared under a previous 510(k) submission for a different device, or if the indication was previously cleared for the EKO 7 in an earlier submission (which is unlikely in a new 510(k) for the system itself). It does not imply a performance study comparing the EKO 7's performance against pre-defined acceptance criteria.
In summary: This 510(k) submission establishes substantial equivalence based on technological characteristics and intended uses aligning with predicate devices, and adherence to recognized safety standards. It does not contain the detailed performance study information requested.
{0}------------------------------------------------
510(k) Premarket Notification
19 2010
EKO 7 Diagnostic Ultrasound System
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
1. Submitter's Information: 21 CFR 807.92(a)(1)
MEDISON CO., LTD. 1003, Daechi-dong, Gangnam-gu, Seoul 135-280, Korea
Contact Person: Mr. Kyung-Am, Shim Regulatory Affairs Manager
| Telephone: | 82.2.2194.1381 |
|---|---|
| Facsimile: | 82.2.2194.1399 |
| Email: | kashim@medison.com |
Data Prepared: March 25, 2010
2. Name of the device:
Common/Usual Name:
Diagnostic Ultrasound System and Accessories
Proprietary Name:
EKO 7 Diagnostic Ultrasound System
| Classification Names: | FR Number | Product Code |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | IYN |
| Ultrasound Pulsed Echo Imaging System | 892.1560 | IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | ITX |
3. Identification of the predicate or legally marketed device:
K092159, ACCUVIX V20 Diagnostic Ultrasound System K093849, ACCUVIX V10 Diagnostic Ultrasound System K020789, GE Vivid 3 Expert/Pro Diagnostic Ultrasound System
510(k) Summary / Statement Certification
ATTACHMENT 1
{1}------------------------------------------------
4. Device Description:
The EKO 7 is a dedicated cardiac purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, color Doppler imaging, power Doppler imaging, Harmonic imaging, PW spectral Doppler mode, CW spectral Doppler mode or as a combination of these modes. The EKO 7 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The EKO 7 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The EKO 7 has been designed to meet the following product safety standards:
- UL 60601-1, Safety requirements for Medical Equipment
- CSA C22.2 No. 601.1, Safety requirements for Medical Equipment
- IEC60601-2-37, Diagnostic Ultrasound Safety Standards
- EN/IEC60601-1, Safety requirements for Medical Equipment
- EN/IEC60601-1-2, EMC requirements for Medical Equipment
- NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- IEC 61157, Declaration of the acoustic output
- ISO10993-1, Biocompatibility
છે. Intended Uses:
The EKO 7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Adult Cephalic, Trans-esophageal (non-Cardiac, Cardiac), Muscular-Skeletal (conventional. superficial), Cardiac Adult, Cardiac Pediatric and Peripheral-vessel.
Technological Characteristics: 6.
The EKO 7 is substantially equivalent to the ACCUVIX V20 Diagnostic Ultrasound System, cleared via K092159, and the ACCUVIX V10 Diagnostic Ultrasound System, cleared via K094623. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All system allow for specialized measurements of structures and flow, and calculations.
END of 510(K) Summary
510(k) Summary / Statement Certification
ATTACHMENT 1
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The eagle is facing to the left. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JUL 1 9 2010
Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K101455
Trade/Device Name: EKO 7 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: June 23, 2010 Received: June 24, 2010
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 EKO 7 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| C1-4EC | P2-4BA |
|---|---|
| C2-6IC | P3-8CA |
| L3-8 | P4-12 |
| L5-13IS | CW2.0 |
| MPT3-7 | CW4.0 |
{3}------------------------------------------------
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your de 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 895. 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.
Sincerely vours, -
Mahal D.O.K. Kim
Donald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: EKO 7 Diagnostic Ultrasound System
Indications for Use:
The EKO 7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-esophageal (non-Cardiac, Cardiac), Muscular-Skeletal (conventional, superficial), Cardiac Adult, Cardiac Pediatric and Peripheral-vessel.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR .
· Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Michael P. O'Keefe
Page 1 of 12
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K101455
Indications For Use
{5}------------------------------------------------
510(k) No.:
Device Name: EKO 7 Diagnostic Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| (Track I only) | (Tracks I & III) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | N | N | N | N | N | Note 1 | Notes 4, 7 | |
| Abdominal | N | N | N | N | N | Note 1 | Notes 4, 7 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | N | Note 1 | Note 5,6,7,9 | |
| Small Organ (See Note 5) | N | N | N | N | N | Note 1 | Note 5,6,7,9 | |
| Neonatal Cephalic | N | N | N | N | N | Note 1 | Note 4, 7 | |
| Adult Cephalic | N | N | N | N | N | Note 1 | Note 4,7 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | N | N | N | N | N | Note 1 | Note 7 | |
| Musculo-skel. (Convent.) | N | N | N | N | N | Note 1 | Note 5,6,7,9 | |
| Musculo-skel. (Superfic.) | N | N | N | N | N | Note 1 | Note 5,6,7,9 | |
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | N | N | N | N | N | Note 1 | Note 4,7 | |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | Note 1 | Note 4,7 |
| Trans-esophageal (Cardiac) | N | N | N | N | N | Note 1 | Note 7 | |
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | N | Note 1 | Note 5,6,7,9 |
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+C+PW, B+PD+PW, B+C+CW, B+PD+CW, B+C+M, Dual B, Dual B+C, Dual B+PD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) / Pulse Inversion Harmonic Imaging
510K
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety.
16-1545
{6}------------------------------------------------
Section 1.3, Page 3
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
510(k) No.:
Device Name: C1-4EC for use with EKO 7
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal (See Note 3) | P | P | P | P | P | Note 1 | Notes 7 |
| Abdominal | P | P | P | P | P | Note 1 | Notes 7 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | Note 1 | Notes 7 | ||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared under K060087; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+C+PW, B+PD+PW, B+C+CW, B+PD+CW, B+C+M, Dual B, Dual B+C, Dual B+PD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) / Pulse Inversion Harmonic Imaging
510F
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Nihil D'K
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
{7}------------------------------------------------
510(k) No.:
Device Name: C2-6IC for use with EKO 7
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | P | P | P | P | P | Note 1 | Notes 7 | |
| Abdominal | P | P | P | P | P | Note 1 | Notes 7 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | Laparoscopic | |||||||
| &Other | Pediatric | P | P | P | P | Note 1 | Notes 7 | |
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared under K092159; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+C+PW, B+PD+PW, B+C+CW, B+PD+CW, B+C+M, Dual B, Dual B+C, Dual B+PD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) / Pulse Inversion Harmonic Imaging
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
ation and Safety
(Division Sign-Off)
Indications For Use
Office of In Vitro Diagnostic Device Evaluation and Sa
510K K101455
Division of Radiological Devices
{8}------------------------------------------------
510(k) No.:
Device Name: L3-8 for use with EKO 7
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | Note 1 | Note 5, 6, 7, 9 | ||
| Small Organ (See Note 5) | N | N | N | N | Note 1 | Note 5, 6, 7, 9 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | Note 1 | Note 5, 6, 7, 9 | ||
| Musculo-skel. (Superfic.) | N | N | N | N | Note 1 | Note 5, 6, 7, 9 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | Note 1 | Note 5, 6, 7, 9 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+C+PW, B+PD+PW, B+C+CW, B+PD+CW, B+C+M, Dual B, Dual B+C, Dual B+PD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) / Pulse Inversion Harmonic Imaging
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Indications For Use
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K101455
Division of Radiological Devices
{9}------------------------------------------------
510(k) No.:
Device Name: L5-13IS for use with EKO 7
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note 1 | Note 5, 6, 7, 9 | ||
| Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 5, 6, 7, 9 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Note 5, 6, 7, 9 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 5, 6, 7, 9 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note 1 | Note 5, 6, 7, 9 | |
| Other (spec.) |
N= new indication; P= previously cleared under K092159; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+C+PW, B+PD+PW, B+C+CW, B+PD+CW, B+C+M, Dual B, Dual B+C, Dual B+PD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) / Pulse Inversion Harmonic Imaging
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices
Indications For Use
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K101455
{10}------------------------------------------------
510(k) No.:
Device Name: MPT3-7 for use with EKO 7
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | Combined* | Other | |
| (Track I only) | (Tracks I & III) | Doppler* | (Spec.) | (Spec.) | |||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal (See Note 3) | |||||||||
| Abdominal | |||||||||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging | Laparoscopic | ||||||||
| &Other | Pediatric | ||||||||
| Small Organ (See Note 5) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | N | N | N | N | Note 1 | Note 7 | |||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | ﻤﺴ | ||||||||
| Cardiac Adult | 1 | ||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | N | N | N | N | Note 1 | Note 7 | |||
| Other (spec.) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+C+PW, B+PD+PW, B+C+CW, B+PD+CW, B+C+M, Dual B, Dual B+C, Dual B+PD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) / Pulse Inversion Harmonic Imaging
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
Indications For Use
{11}------------------------------------------------
510(k) No.:
Device Name: P2-4BA for use with EKO 7
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal (See Note 3) | |||||||||
| Abdominal | P | P | P | P | P | Note 1 | Note 4, 7 | ||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging& Other | Laparoscopic | ||||||||
| Pediatric | |||||||||
| Small Organ (See Note 5) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | P | P | P | P | P | Note 1 | Note 4, 7 | ||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7 | ||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (spec.) |
N= new indication; P= previously cleared under K092159; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+C+PW, B+PD+PW, B+C+CW, B+PD+CW, B+C+M, Dual B, Dual B+C, Dual B+PD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) / Pulse Inversion Harmonic Imaging
510k
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
{12}------------------------------------------------
510(k) No.:
Device Name: P3-8CA for use with EKO 7
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared under K092159; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+C+PW, B+PD+PW, B+C+CW, B+PD+CW, B+C+M, Dual B, Dual B+C, Dual B+PD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) / Pulse Inversion Harmonic Imaging
510k
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Michael D. Kirk
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
{13}------------------------------------------------
510(k) No.:
Device Name: P4-12 for use with EKO 7
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | N | N | N | N | N | Note 1 | Note 4, 7 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | N | Note 1 | Note 4, 7 | |
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | N | N | N | N | N | Note 1 | Note 4, 7 | |
| Adult Cephalic | N | N | N | N | N | Note 1 | Note 4, 7 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | N | N | N | N | N | Note 1 | Note 4, 7 | |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | Note 1 | Note 4, 7 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+C+PW, B+PD+PW, B+C+CW, B+PD+CW, B+C+M, Dual B, Dual B+C, Dual B+PD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) / Pulse Inversion Harmonic Imaging
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
Indications For Use
510K K101455
{14}------------------------------------------------
510(k) No.:
Device Name: CW2.0 for use with EKO 7
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging& Other | Fetal (See Note 3) | ||||||||
| Abdominal | |||||||||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (See Note 5) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | P | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac | Cardiac Adult | P | |||||||
| Cardiac Pediatric | P | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| PeripheralVessel | Peripheral vessel | P | |||||||
| Other (spec.) |
N= new indication; P= previously cleared under K092159; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+C+PW, B+PD+PW, B+C+CW, B+PD+CW, B+C+M, Dual B, Dual B+C, Dual B+PD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) / Pulse Inversion Harmonic Imaging
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices
Indications For Use
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K101455
{15}------------------------------------------------
Section 1.3, Page 12
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
510(k) No.:
Device Name: CW4.0 for use with EKO 7
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging&Other | Fetal (See Note 3) | ||||||||
| Abdominal | |||||||||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | ||||||||
| Small Organ (See Note 5) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | P | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | P | ||||||||
| Cardiac | Cardiac Pediatric | P | |||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| PeripheralVessel | Peripheral vessel | P | |||||||
| Other (spec.) |
N= new indication; P= previously cleared under K092159; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+C+PW, B+PD+PW, B+C+CW, B+PD+CW, B+C+M, Dual B, Dual B+C, Dual B+PD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) / Pulse Inversion Harmonic Imaging
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Indications For Use
Division of Radiological Devices tion and Safety Office of Ir
§ 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.