ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM

K103397 · Medison Co., Ltd. · IYN · Feb 25, 2011 · Radiology

Device Facts

Record IDK103397
Device NameACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM
ApplicantMedison Co., Ltd.
Product CodeIYN · Radiology
Decision DateFeb 25, 2011
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.1550
Device ClassClass 2
AttributesPediatric, 3rd-Party Reviewed

Intended Use

The ACCUVIX XG Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Intra-operative, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.

Device Story

ACCUVIX XG is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data and displays it in B-mode, M-mode, Color/Power Doppler, and 3D/4D imaging modes. Operated by healthcare professionals in clinical settings, the system allows for anatomical measurements and analysis packages to assist in diagnosis. It features real-time acoustic output display (mechanical and thermal indices). The system processes received echoes to generate images of anatomic structures and fluid flow. Output is viewed by clinicians to inform diagnostic decision-making. Benefits include non-invasive visualization of internal structures and blood flow for various clinical applications.

Clinical Evidence

Bench testing only. The device complies with recognized safety standards including UL 60601-1, CSA C22.2 No. 601.1, IEC 60601-2-37, NEMA UD-2, NEMA UD-3, IEC 61157, and ISO 10993-1 for biocompatibility.

Technological Characteristics

Mobile diagnostic ultrasound system. Materials comply with ISO 10993-1. Sensing via ultrasonic pulsed Doppler and pulsed echo imaging. Energy source: electrical. Connectivity: standard ultrasound system interfaces. Software-controlled. Sterilization: compatible with standard transducer disinfection protocols. Features include Tissue Harmonic Imaging (THI), 3D/4D imaging, Panoramic imaging, and ElastoScan.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal, abdominal, intra-operative, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, and peripheral vessel applications. Includes guidance for biopsy and infertility monitoring.

Regulatory Classification

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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ # 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS FEB 2 5 2011 This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CER. Port 807, Submort E. Section 807, 20 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: Kyeong-Mi, Park Regulatory Affairs Manager | Telephone: | 82.2.2194.1373 | |------------|----------------| | Facsimile: | 82.2.556.9209 | Data Prepared: August 12, 2010 ### 2. Name of the device: Common/Usual Name: Diagnostic Ultrasound System and Accessories Proprietary Name: ACCUVIX XG 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: K101455, EKO 7 Diagnostic Ultrasound System K092159, ACCUVIX V20 Diagnostic Ultrasound System 510(k) Summary / Statement Certification {1}------------------------------------------------ ### 4. Device Description: The ACCUVIX XG is a general 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 image and Colopher the Gala as B mode, W mode, W mode, Color Doppler imaging, 3D imaging mode (real time 4D ) imaging, 3D imaging mode (real time 4D imaging mode) or as a combination of these modes. The ACCUVIX XG also gives the operator the ability to measure anatomical structures and offers and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The ACCUVIX XC has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The ACCUVIX XG has been designed to met the following product safety standards: - UL 60601-1, Safety requirements for Medical Equipment - CSA C22.2 No. 601.1, Safety requirements for Medical Equipment - EC60601-2-37, Diagnostic Ultrasound Safety Standards - EN/IEC60601-1, Safety requirements for Medical Equipment - NEMALID -1-2, EMC requirements for Medical Equipment - NEMA UD-2, Acoustic Output Measurement Stadiard 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 ### 5. Intended Uses: The ACCUVIX XG Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Intra-operative, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-recal, Trans-vaginal, Muscularive, Pedialit, Sinan Organis, Neonalia, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel. ### 6. Technological Characteristics: The ACCUVIX XG is substantially equivalent to the ACCUVIX V20 Diagnostic Ultrasound System, cleared via K092159, and the EKO 7 Diagnostic Ultrasound System, cleared via K101455. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate onscreen 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 ATTACHEMENT I {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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with outstretched wings. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313 FEB 2 5 2011 Re: K103397 Trade/Device Name: ACCUVIX XG Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYO, ITX, and IYN Dated: February 8, 2011 Received: February 10, 2011 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 ACCUVIX XG Diagnostic Ultrasound System, as described in your premarket notification: #### Transducer Model Number | C1-4EC | VR5-9 | P2-4BA | V5-9 | |------------|---------|--------|-------| | C2-61C | L3-8 | P3-8CA | V6-12 | | C4-9/10ED | L5-131S | P4-12 | CW2.0 | | ER4-9/10ED | LF5-12 | 3DC2-6 | CW4.0 | | EV4-9/10ED | LS5-13 | V4-8 | | {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 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/CDRH0ffices/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 Paul Hardy at (301) 796-6542. Sincerely Yours, Mary Stott Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure(s) {4}------------------------------------------------ ### SECTION 1.3 INDICATIONS FOR USE 510(k) Number (if known): Device Name: ACCUVIX XG Diagnostic Ultrasound System ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ The ACCUVIX XG Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeietal (Conventional, Superficial), Cardian Cephalia, Capaciti Cardiac Pediatric, Peripheral vessel V 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) Mary S. Patel (Division Sign-Off) Indications for Use Division of Radiological Devices Office of In Vitro Diagnostic Devices Office of In Vitro Diagnostic Devices Office of In Vitro Diagnostic Devices Concession LCD ココ ヘ ヘ ヘ ヘ ヘ {5}------------------------------------------------ #### 510(k) No .: ## Device Name: ACCUVIX XG Diagnostic Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: ("linical A | Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|----------------|----------------------|---------------------------| | General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging<br>& Other | Fetal (See Note 3) | N | N | N | N | N | Note I | Notes 2, 7, 8 | | | Abdominal | N | N | N | N | N | Note I | Notes 4, 7 | | | Intra-operative (See Note 6) | N | N | N | | N | Note I | Notes 8, 9 | | | Intra-operative (Neuro.) | N | N | N | | N | Note I | Notes 8, 9 | | | Laparoscopic | | | | | | | | | | Pediatric | N | N | N | | N | Note I | Note 2, 5, 6, 7, 8, 9, 10 | | | Small Organ (See Note 5) | N | N | N | | N | Note I | Note 2, 5, 6, 7, 8, 9, 10 | | | Neonatal Cephalic | N | N | N | | N | Note I | Note 2, 7, 8, 9 | | | Adult Cephalic | N | N | N | N | N | Note I | Note 4, 7 | | | Trans-rectal | N | N | N | | N | Note I | Note 2, 7, 8, 10 | | | Trans-vaginal | N | N | N | | N | Note I | Note 2, 7, 8, 10 | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | N | N | N | | N | Note I | Note 2, 5, 6, 7, 8, 9, 10 | | | Musculo-skel. (Superfic.) | N | N | N | | N | Note I | Note 2, 5, 6, 7, 8, 9, 10 | | | Intra-luminal | | | | | | | | | | Other (spec.) | | | | | | | | | Cardiac | Cardiac Adult | N | N | N | N | N | Note I | Note 4, 7 | | | Cardiac Pediatric | N | N | N | N | N | Note I | Note 4, 7 | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | Note I | Note 2, 5, 6, 7, 9, 10 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note I : B+M, B+PW, B+C, B+PD, B+C+PW, B+C+PW, B+C+M, Dual B, Dual B+C, Dual B+C, 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) Note 8: 3D imaging Note 9: Panoramic imaging Note 10: ElastoScan Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109) Mary S Pastl (Division Sign-Off) Division of Magiclogical Devices Office of In Vitro Diagnostic Device Evaluation and Safety Section 1.3, page 2 {6}------------------------------------------------ 510(k) No.: ### Device Name: Ci-4EC for use with ACCUVIX XG 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 7, 8 | | | Abdominal | P | P | P | | P | Note 1 | Notes 2, 7, 8 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | | | Pediatric | P | P | P | | P | Note 1 | Notes 2, 7, 8 | | | 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<br>Vessel | Peripheral vessel | | | | | | | | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K101455; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Notel : B+M, B+PV, B+C', B+PD, B+C'+PW, B+C+PW, B+C+M, Dual B, Dual B+C, Dual B+C, 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 4. COLOR MIXING Note 5: I've example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatul patients Note 6: Abdominal organs and peripheral vessel Note 7: Tissue Harmonic Imaging (THI) Note 8: 3D imaging Note B. 3D imaging Note 9: Panoramic imaging Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109) Mary Shatt (Division Sign-Off) Indications for Use Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety {7}------------------------------------------------ #### 510(k) No .: ### Device Name: C2-6IC for use with ACCUVIX XG Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Annocation | | Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |---------------------------|------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|------------------| | General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 7, 8 | | | Abdominal | P | P | P | | P | Note I | Notes 2, 7, 8 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | | | Pediatric | P | P | P | | P | Note 1 | Notes 2, 7, 8 | | | 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<br>Vessel | Peripheral vessel | | | | | | | | | | Other (spec.) | | | | | | | | | | | | | | | | | | N= new indication; P= previously cleared by FDA K092159; E= added under Appendix E #### Additional Comments: Color Doppier includes Power (Amplitude) Doppier Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+PD+PW, B+C+M Dual F Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+C+PW, B+PD+PW, B+C+M, Dual B+C, 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) 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) Mary S. Patel (Division Sign-Off) ion of Radiological Diagnostic Device Evaluation and Safety Section 1.3, page 4 10K 10397 {8}------------------------------------------------ #### 510(k) No.: ## Device Name: C4-9/10ED for use with ACCUVIX XG Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Anolication | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | | |---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|--| | General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | | Ophthalmic | Ophthalmic | | | | | | | | | | | Fetal (See Note 3) | P | P | P | | P | Note I | Notes 2, 7, 8 | | | | Abdominal | P | P | P | | P | Note I | Notes 2, 7, 8 | | | | Intra-operative (See Note 6) | | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | | | | Pediatric | P | P | P | | P | Note I | Notes 2, 7, 8 | | | | Small Organ (See Note 5) | P | P | P | | P | Note I | Notes 2, 7, 8 | | | | Neonatal Cephalic | P | P | P | | P | Note I | Notes 2, 7, 8 | | | | 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<br>Vessel | Peripheral vessel | P | P | P | | P | Note I | Notes 2, 7, 8 | | | | Other (spec.) | | | | | | | | | N= new indication; P= previously cleared by FDA K092159; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note I: B+M, B+PW, B+C+PW, B+C+PW, B+C+PW, B+PD+PW, B+C+M, Dual B+C, Dual B+C, Duul B+PD, Duul B+PD, Duul B+PD, Duul B+PD, Duul B+PD, Duul B+PD, Duul B+PD, Duul B+PD, Duul B+ Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development Note 4: Color M-mode Note 5: I've 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) 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) Mary Statts (Division Sign-Division of Radiological De Vitro Diagnostic Device Evaluation and Safety Office of In Indications for Use Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safe {9}------------------------------------------------ #### 510(k) No.: ### Device Name: ER4-9/10ED for use with ACCUVIX XG Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Annlication | Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------| | General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal (See Note 3) | | | | | | | | | | Abdominal | | | | | | | | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (See Note 5) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | P | P | P | | P | Note I | Note 2, 7, 8 | | | Trans-vaginal | P | P | P | | P | Note I | Note 2, 7, 8 | | | 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<br>Vessel | Peripheral vessel | | | | | | | | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K092159; E= added under Appendix E Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+C+PW, B+C+PW, B+C+PW, B+C+M, Dual B, Dual B+C, 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) 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) Mary S Patel (Division Sign-Off) Olvision of Radiological Devioss o Diagnosuc Device Evaluation and Safety Section 1.3, page 6 {10}------------------------------------------------ #### 510(k) No .: ## Device Name: EV4-9/10ED for use with ACCUVIX XG Intended Use. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Annlication | Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------| | General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging<br>& 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 | | | | | | | | | | Trans-rectal | P | P | P | | P | Note I | Note 2, 7, 8 | | | Trans-vaginal | P | P | P | | P | Note I | Note 2, 7, 8 | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (spec.) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K092159; E= added under Appendix E Additional Comments: Color Doppler includes Power (Amplitude) Doppier Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+C+PW, B+C+M, Dual B, Dual B+C, Dual B+C, 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) 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) Munu S. Patil (Division Sign-Off) Division of Aagliological Devices Vitro Diagricstic Dovice Evaluation and Safety Section 1.3, page 7 510K 10397 {11}------------------------------------------------ ### 510(k) No .: Device Name: VR5-9 for use with ACCUVIX XG Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application | General<br>(Track I only) | Clinical Application<br>Specific<br>(Tracks I & III) | B | M | PWD | CWD | Mode of Operation (*includes simultaneous B-mode)<br>Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | |---------------------------|------------------------------------------------------|---|---|-----|-----|------------------------------------------------------------------------|----------------------|------------------| | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging<br>& 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 | | | | | | | | | | Trans-rectal | N | N | N | | N | Note 1 | Note 2, 7, 8, 10 | | | Trans-vaginal | N | N | N | | N | Note 1 | Note 2, 7, 8, 10 | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | | Musculo-skel. (Supertic.) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (spec.) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral<br>Vessel | 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+M, B+PW, B+C; B+PD, B+C+PW, B+C+PW, B+C+M, Dual B, Dual B+C, Dual B+C, Dual B+C, Dual B+C, Dual B+C, Dual B+C, Dual B+C, Dual B+C, Dual B+C, 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 Hannonic Imaging (THI) Note 8: 3D imaging · Note 9: Panoramic imaging Note10: ElastoScan Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109) Mary S. Postell (Division Sign Off) Indications for Use (Division Sign-Division of Radiological Devices Diagnostic Device Evaluation and Safety {12}------------------------------------------------ ### 510(k) No.: Device Name: L3-8 for use with ACCUVIX XG Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application | Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|--------------------| | General<br>(Track I only) | Specific<br>(Tracks I & II) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging<br>& Other | Fetal (See Note 3) | | | | | | | | | | Abdominal | | | | | | | | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9 | | | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9 | | | Neonatal Cephalic | | | | | | | Note 2, 5, 6, 7, 9 | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9 | | | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9 | | | Intra-luminal | | | | | | | | | | Other (spec.) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K101455; E= added under Appendix E Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, B+C+M, Dual B, Dual B+C, Dual B+C, 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: I'or 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) 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) Mury Stattl (Division Sign-Off) ign of Radiological Devices Device Evaluation and Safety Section 1.3, page 9 {13}------------------------------------------------ ### 510(k) No.: Device Name: L5-131S for use with ACCUVIX XG 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 | Color Doppler* | 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 | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 10 | | | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 10 | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 10 | | | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 10 | | | Intra-luminal | | | | | | | | | | Other (spec.) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 10 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K092159; E= added under Appendix E Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+CW, B+CW, B+CW, B+C+PW, B+C+M, Dual B+C, Dual B+C, Dual B+C, Dual B+C, Dual B+C, Dual B+C, Dual B+C, 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) Note 8: 3D imaging Note 9: Panoramic imaging Note10: ElastoScan Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109) Mary Sasted (Division Sign-Off) Indications for Use Division of Rediological Devices Office of In Vitro Diagnostic Device Evaluation and Safety {14}------------------------------------------------ #### 510(k) No.: ### Device Name: LF5-12 for use with ACCUVIX XG 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal (See Note 3) | | | | | | | | | | Abdominal | | | | | | | | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | | | Pediatric | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 10 | | | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 10 | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 10 | | | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 10 | | | Intra-luminal | | | | | | | | | | Other (spec.) | | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 10 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K092159; E= added under Appendix E Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: 8+M, B+PW, B+C, B+PD, B+C+PW, B+C+PW, B+C+M, Dual B, Dual B+C, Dual B+C, Duul 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, pediativ and neonatal patients Note 6: Abdominal organs and peripheral vessel Note 7: Tissue Harmonic Imaging (THI) Note 8: 3D imaging Note 9: Panoramic imaging Note10: LiastoScan Concurrence of CDRH. Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109) Mary Stat on of Redininguest No Section 1.3, page 11 {15}------------------------------------------------ ### 510(k) No .: ## Device Name: LS5-13 for use with ACCUVIX XG 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal (See Note 3) | | | | | | | | | | Abdominal | | | | | | | | | | Intra-operative (See Note 6) | P | P | P | | P | Note I | Note 8, 9 | | | Intra-operative (Neuro.) | P | P | P | | P | Note 1 | Note 8, 9 | | Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | | | Pediatric | P | P | P | | P | Note 1 | Note 8, 9 | | | Small Organ (See Note 5) | P | P | P | | P | Note I | Note 8, 9 | | | Neonatal Cephalic | P | P | P | | P | Note 1 | Note 8, 9 | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | P | P | P | | P | Note I | Note 8, 9 | | | Musculo-skel. (Supertic.) | P | P | P | | P | Note I | Note 8, 9 | | | Intra-luminal | | | | | | | | | | Other (spec.) | | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | Note I | Note 5, 6, 9 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K093849; E= added under Appendix E Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, B+C+M, Dual B+C, Dual B+C, Dual B+C, Dual B+PD Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follivle 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) Note 8: 3D imaging Note 9: Panoramic imaging Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Us…
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