6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System

K161359 · Esaote, S.p.A. · IYN · Jul 19, 2016 · Radiology

Device Facts

Record IDK161359
Device Name6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System
ApplicantEsaote, S.p.A.
Product CodeIYN · Radiology
Decision DateJul 19, 2016
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.1550
Device ClassClass 2
AttributesPediatric

Intended Use

Esaote's Model 6400 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 6400 provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. Esaote's Model 7400 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 7400 provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. Esaote's Model 7410 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 7410 provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Device Story

The 6400, 7400, and 7410 Ultrasound Systems are diagnostic imaging devices used in clinical settings. The 6400 is a mainframe system; the 7400 and 7410 are compact, portable systems. These devices use various ultrasound probes (phased, convex, linear, volumetric) to acquire acoustic data, which is processed to generate B-mode, M-mode, Doppler, Color Flow Mapping, and 3D/4D images. The systems feature advanced imaging modes like Tissue Enhancement Imaging (TEI), Multi View (MView), and Tissue Velocity Mapping (TVM). Operators (physicians/technicians) use the control panel or touchscreen to manage imaging, perform measurements, and utilize features like Needle Visibility, QAS (Qualitative Elastosonography), and the MyLibrary tutorial. The output is displayed on an integrated LCD screen, assisting clinicians in diagnostic assessment, biopsy guidance, and needle placement for procedures like nerve blocks. The systems support wireless connectivity and battery operation (7400/7410).

Clinical Evidence

No clinical tests were performed. Substantial equivalence is supported by non-clinical bench testing, including acoustic output measurements, biocompatibility, cleaning/disinfection effectiveness, and thermal, electromagnetic, and mechanical safety testing per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD-2, and NEMA UD-3 standards.

Technological Characteristics

Mainframe (6400) and compact/portable (7400, 7410) ultrasound systems. Features LCD color display, wireless capability, and battery power (7400/7410). Supports phased, convex, linear, and volumetric probes. Imaging modes: B-mode, M-mode, Doppler, CFM, AD, TVM, 3D/4D, and ElaXto. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-37. Acoustic output display per AIUM/NEMA standards.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in patients requiring general ultrasound studies including cardiac, vascular, abdominal, fetal, small organs, musculoskeletal, and urological applications. Includes guidance for biopsy, needle placement, and peripheral nerve blocks.

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

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, resembling a family or group of people. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 19, 2016 Esaote S.p.A % Allison Scott, RAC Managing Consultant Navigant Consulting, Inc. 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268 Re: K161359 Trade/Device Name: 6400 Ultrasound System, 7400 Ultrasound System, 7410 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: May 12, 2016 Received: May 16, 2016 Dear Ms. Scott: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Michael D'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) ## Device Name 6400 Ultrasound System, 7400 Ultrasound System, 7410 Ultrasound System ## Indications for Use (Describe) Esaote's Model 6400 is a mainframe ultrasound system diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 6400 provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. Esaote's Model 7400 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 7400 provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. Esaote's Model 7410 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other. Urologic. Model 7410 provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. |×| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ## FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ | Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | | | | | | |----------------------------------------------------------------------------------------------|--------------------|---|-----|-----|------------------|------------------------------|-----------------|----------------------------------|---------------------------|-----------------| | Clinical Application | Mode of Operations | | | | | | | | | | | | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD) | Combined<br>[4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | | Ophthalmic | P | P | P | P | P | P | P | | P | P: 5, 6 | | Fetal | P | P | P | P | P | P | P | | P | P: 5, 6 | | Abdominal | P | P | P | P | P | P | P | | P | P: 5 | | Intraoperative (Abdominal) | P | P | P | P | P | P | P | | P | P: 5 | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | P | P | P | P | P | P | P | | P | P: 5 | | Small Organs [1] | P | P | P | P | P | P | P | | P | P: 5 | | Neonatal Cephalic | P | P | P | P | P | P | P | | P | P: 5 | | Adult Cephalic | P | P | P | P | P | P | P | | P | P: 5 | | Cardiac [2] | P | P | P | P | P | P | P | P | P (7) | P: 5 | | Transesophageal (Cardiac) [2] | P | P | P | P | P | P | P | | P | P: 5 | | Transesophageal (Non Cardiac) | | | | | | | | | | | | Transrectal | P | P | P | P | P | P | P | | P | P: 5, 6 | | Transvaginal | P | P | P | P | P | P | P | | P | P: 5, 6 | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | P | P | P | P | P | P | P | | P | P: 5 | | Laparoscopic | P | P | P | P | P | P | P | | P | P: 5 | | Musculo-skeletal Conventional | P | P | P | P | P | P | P | | P | P: 5 | | Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | | P | P: 5 | | Other (Urological) | P | P | P | P | P | P | P | | P | P: 5 N: 6 | Diagnostic ultrasound imaging or fluid flow analysis of human body as 6400 Internation Apper by F ed usly P: Previo US Small Organs includes Breast, Thyroid and Testicles [2] Cardiac is Adult and Pediatric. [3] Musculo Skeletal - Nerve Block [1] Small Organs includes Breast, Thyroid and Testicle [2] Cardiac is Adult and Pediatrio [3] Museulo Skeletal - Ine Block [4] Museulo Skeletal - InterPW+CW+CFM+PD [5] Compou EC Confidence, inches arc D, in CH cord EC Computed, inches arc D, in CH cord 6] 3D/4D 7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification of the left ventricular endocardial bor viously cleared via K142008 and to be cleared with this submissio Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (Olf {5}------------------------------------------------ | Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Tissue Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |----------------------------------|---|---|-----|-----|---------------|------------------------|--------------|-------------------------------|------------------------|-----------------| | Ophthalmic | P | P | P | P | P | P | P | P | P | P: 5, 6 | | Fetal | P | P | P | P | P | P | P | P | P | P: 5, 6 | | Abdominal | P | P | P | P | P | P | P | P | P | P: 5 | | Intraoperative (Abdominal) | P | P | P | P | P | P | P | P | P | P: 5 | | Intraoperative Neurological | P | P | P | P | P | P | P | P | P | P: 5 | | Pediatric | P | P | P | P | P | P | P | P | P | P: 5 | | Small Organs [1] | P | P | P | P | P | P | P | P | P | P: 5 | | Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P: 5 | | Adult Cephalic | P | P | P | P | P | P | P | P | P | P: 5 | | Cardiac [2] | P | P | P | P | P | P | P | P | P (7) | P: 5 | | Transesophageal (Cardiac) [2] | P | P | P | P | P | P | P | P | P | P: 5 | | Transesophageal (Non Cardiac) | P | P | P | P | P | P | P | P | P | P: 5, 6 | | Transrectal | P | P | P | P | P | P | P | P | P | P: 5, 6 | | Transvaginal | P | P | P | P | P | P | P | P | P | P: 5 | | Transurethral | P | P | N | N | N | N | N | N | P | N: 5 | | Intravascular | P | P | P | P | P | P | P | P | P | P: 5 | | Peripheral Vascular | P | P | P | P | P | P | P | P | P | P: 5 | | Laparoscopic | P | P | P | P | P | P | P | P | P | P: 5 | | Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P: 5 | | Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P | P | P: 5 | | Other (Urological) | P | P | P | P | P | P | P | P | P | P: 5 N: 6 | id flow 7400 Interede S LLC Standard Options Includes Brass Drain, Overflow and Fasteners 2) Cardiac is Adult and Pediatric [3] Musculo Skeletal - Nerve Block [ I ] Small Organs includes Breast, Thyroid and Testicles [2] Cardiac is Adult and Pediatric [3] Museulo Skeletal - Ne Brediatric [4] Museulo Skeletal - Net-DW+CW+CW+CW+CFM+P IEC Combined Modes are: B, B/R, B/P, B/R/P, C/R, C/P, C/R/P. All new Compound Imaging Modes are: Multiplanar (MPR) and Summed Compound Imaging (MV-Flow) 3D/4D [7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of t r production of the open in the ventricle opacification and visualization of the left ventricular endocardial border reviously cleared via K142008 and to be cleared with this submission Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR) {6}------------------------------------------------ 7 4 1 0 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo | Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD) | Combined<br>[4] | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | |--------------------------------------|---|---|-----|-----|------------------|------------------------------|-----------------|---------------------------------|---------------------------|-----------------| | Ophthalmic | P | P | P | P | P | P | P | P | P | P: 5, 6 | | Fetal | P | P | P | P | P | P | P | P | P | P: 5, 6 | | Abdominal | P | P | P | P | P | P | P | P | P | N: 5 | | Intraoperative (Abdominal) | N | N | N | N | N | N | N | N | N | N: 5 | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | P | P | P | P | P | P | P | P | P | P: 5 | | Small Organs [1] | P | P | P | P | P | P | P | P | P | P: 5 | | Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P: 5 | | Adult Cephalic | P | P | P | P | P | P | P | P | P | P: 5 | | Cardiac [2] | P | P | P | P | P | P | P | P | P | P: 5 | | Transesophageal (Cardiac) [2] | P | P | P | P | P | P | P | P | P | P: 5 | | Transesophageal (Non Cardiac) | | | | | | | | | | | | Transrectal | P | P | P | P | P | P | P | P | P | P: 5 N: 6 | | Transvaginal | P | P | P | P | P | P | P | P | P | P: 5 N: 6 | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | P | N | N | N | N | N | N | N | N | N: 5 | | Laparoscopic | N | N | N | N | N | N | N | N | N | N: 5 | | Musculo-skeletal Conventional<br>[3] | P | P | P | P | P | P | P | P | P | P: 5 | | Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P | P | P: 5 | | Other (Urological) | P | P | P | P | P | P | P | P | P | P: 5 N: 6 | N: New indication; P: Previously cleared by FDA; E:Added under Appendix E J. SCHUMANN, MORRIS BAKER, M. THOMAS, AND ASSOCIATES STRUCTURAL ENGINEERS 2) Cardiac is Adult and Pediatric [3] Musculo skeletal - Nerve Block [4] Combined modes are: B+M+PW+CW+CFM+I] E. Compound bearing **maximum** moment F. Compound bearing **minimum** moment [6] 3D/4D Sunburst Imaging [10] 5D/TP [12] Includes control ] | Small Creats mobile & Break, Thynia and reacles | | Master Seesel L. Personal Production | President Production of the loft ventional on the loft ventricular enclocation Previously cleared via K142077 and to be cleare with this submission Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR) {7}------------------------------------------------ | | Model | | | | |----------|--------------------------------------|--------------------------------------|---------------------------------------|-----| | Probe | 6400 (96ch)<br>MyLabSeven<br>K142008 | 7400 (96ch)<br>MyLabAlpha<br>K142008 | 7410 (64 ch)<br>MyLabGamma<br>K142077 | New | | SP2430 | 1 | 1 | | | | SP2442 | 1 | 1 | | | | SP2730 | | | 1 | | | AL2442 | 1 | 1 | 1 | | | AL2443 | 1 | 1 | 1 | | | SL1543 | 1 | 1 | 1 | | | SL2325 | 1 | 1 | 1 | | | SL3116 | 1 | 1 | 1 | | | SL3235 | | | 1 | | | SL3323 | | | 1 | | | SL3332 | | | 1 | | | AC2541 | 1 | 1 | 1 | | | SC3123 | 1 | 1 | 1 | | | SC3421 | | | 1 | | | SI2C41 | 1 | 1 | 1 | 1 | | SE3123 | 1 | 1 | 1 | | | SE3133 | 1 | 1 | 1 | 1 | | IOT342 | 1 | 1 | | | | IH 6-18 | 1 | 1 | 1 | 1 | | IL 4-13 | 1 | 1 | 1 | 1 | | LP 4-13 | 1 | 1 | 1 | 1 | | TLC 3-13 | 1 | 1 | 1 | 1 | | S2MCW | 1 | 1 | 1 | | | S5MCW | 1 | 1 | 1 | | | SHFCW | 1 | 1 | 1 | | | S2MPW | 1 | 1 | | | | ST2613 | 1 | 1 | | | | ST2612 | 1 | 1 | 1 | | | SB2C41 | 1 | 1 | 1 | | | SB3123 | 1 | 1 | 1 | | | LA435 | 1 | | | | | LA523 | 1 | | | | | CA430 | 1 | | | | | EC1123 | 1 | 1 | | | | LP323 | 1 | | | | | TRT33 | 1 | | | | | IOT332 | 1 | | | | | IOE323 | 1 | | | | | BC431 | 1 | | | | | BC441 | 1 | | | | | BE1123 | 1 | | | | {8}------------------------------------------------ | Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Tissue Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |----------------------------------------------------------------------------------------------|--------------------|----------|------------|------------|--------------------------|---------------------------------------|-------------------------|------------------------------------------|-----------------------------------|------------------------| | Ophthalmic | P | P | P | P | P | P | P | | | | | Fetal | P | P | P | P | P | P | P | | | | | Abdominal | P | P | P | P | P | P | P | | | P: 5 | | Intraoperative (Abdominal) | | | | | | | | | | P: 5 | | Intraoperative Neurological | | | | | | | | | | P: 5 | | Pediatric | P | P | P | P | P | P | P | | | P: 5 | | Small Organs [1] | | | | | | | | | | P: 5 | | Neonatal Cephalic | P | P | P | P | P | P | P | | | | | Adult Cephalic | P | P | P | P | P | P | P | | | | | Cardiac [2] | P | P | P | P | P | P | P | | P (7) | P: 5 | | Transesophageal (Cardiac) | | | | | | | | | | | | Transesophageal (Non Cardiac) | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | P | P | P | P | P | P | P | | | P: 5 | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | Musculo-skeletal Superficial [3] | | | | | | | | | | | | Other (Urological) | | | | | | | | | | | | Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Tissue Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative (Abdominal) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | P | P | P | P | P | P | P | | P | P: 5 | | Small Organs [1] | | | | | | | | | | | | Neonatal Cephalic | P | P | P | P | P | P | P | | P | P: 5 | | Adult Cephalic | | | | | | | | | | | | Cardiac [2] | P | P | P | P | P | P | P | P | P | P: 5 | | Transesophageal (Cardiac) | | | | | | | | | | | | Transesophageal (Non Cardiac) | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | P | P | P | P | P | P | P | | P | P: 5 | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional [3] | | | | | | | | | | | | Musculo-skeletal Superficial [3] | | | | | | | | | | | | Other (Urological) | | | | | | | | | | | | Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD) | Combined<br>[4] | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | | Ophthalmic | P | P | P | P | P | P | P | | P | P: 5 | | Fetal | P | P | P | P | P | P | P | | P | P: 5 | | Abdominal | P | P | P | P | P | P | P | | P | P: 5 | | Intraoperative (Abdominal) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | P | P | P | P | P | P | P | | P | P: 5 | | Small Organs [1] | | | | | | | | | | | | Neonatal Cephalic | P | P | P | P | P | P | P | | P | P: 5 | | Adult Cephalic | P | P | P | P | P | P | P | | P | P: 5 | | Cardiac [2] | P | P | P | P | P | P | P | P | P | P: 5 | | Transesophageal (Cardiac) | | | | | | | | | | | | Transesophageal (Non Cardiac) | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | P | P | P | P | P | P | P | | P | P: 5 | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | Musculo-skeletal Superficial [3] | | | | | | | | | | | | Other (Urological) | | | | | | | | | | | | Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | | | | | | | | | | | | | <b>Mode of Operations</b> | | | | | | <b>Clinical Application</b> | <b>B</b> | <b>M</b> | <b>PWD</b> | <b>CWD</b> | <b>Color<br/>Doppler</b> | <b>Amplitude<br/>Doppler<br/>(PD)</b> | <b>Combined<br/>[4]</b> | <b>Tissue Velocity<br/>Mapping (TVM)</b> | <b>Harmonic<br/>Imaging (TEI)</b> | <b>Other (specify)</b> | | Ophthalmic | P | P | P | P | P | P | P | | P | P: 5 | | Fetal | P | P | P | P | P | P | P | | P | P: 5 | | Abdominal | P | P | P | P | P | P | P | | P | P: 5 | | Intraoperative (Abdominal) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | P | P | P | P | P | P | P | | P | P: 5 | | Small Organs [1] | P | P | P | P | P | P | P | | P | P: 5 | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac [2] | P | P | P | P | P | P | P | | P | P: 5 | | Transesophageal (Cardiac) | | | | | | | | | | | | Transesophageal (Non Cardiac) | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | P | P | P | P | P | P | P | | P | P: 5 | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | P | P | P | P | P | P | P | | P | P: 5 | | Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | | P | P: 5 | | Other (Urological) | | | | | | | | | | | | Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Tissue Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | P | P | P | | P | P | P | | P | P: 5 | | Intraoperative (Abdominal) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | E | E | E | | E | E | E | | E | E: 5 | | Small Organs [1] | P | P | P | | P | P | P | | P | P: 5 | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac [2] | P | P | P | | P | P | P | | P | P: 5 | | Transesophageal (Cardiac) | | | | | | | | | | | | Transesophageal (Non Cardiac) | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | P | P | P | | P | P | P | | P | P: 5 | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | P: 5 | | Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | P: 5 | | Other (Urological) | | | | | | | | | | | | Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Tissue Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | | Ophthalmic | P | P | P | P | P | P | P | | | P: 5 | | Fetal | P | P | P | P | P | P | P | | | P: 5 | | Abdominal | P | P | P | P | P | P | P | | | P: 5 | | Intraoperative (Abdominal) | | | | | | | P | | | | | Intraoperative Neurological | | | | | | | P | | | | | Pediatric | P | P | P | P | P | P | P | | | P: 5 | | Small Organs [1] | P | P | P | P | P | P | P | | | P: 5 | | Neonatal Cephalic | | | | | | | P | | | | | Adult Cephalic | | | | | | | P | | | | | Cardiac [2] | P | P | P | P | P | P | P | | | P: 5 | | Transesophageal (Cardiac) | | | | | | | P | | | | | Transesophageal (Non Cardiac) | | | | | | | P | | | | | Transrectal | | | | | | | P | | | | | Transvaginal | | | | | | | P | | | | | Transurethral | | | | | | | P | | | | | Intravascular | | | | | | | P | | | | | Peripheral Vascular | P | P | P | P | P | P | P | | | P: 5 | | Laparoscopic | | | | | | | P | | | | | Musculo-skeletal Conventional | P | P | P | P | P | P | P | | | P: 5 | | Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | | | P: 5 | | Other (Urological)…
Innolitics
510(k) Summary
Decision Summary
Classification Order
Enter a record ID and click Load to view the document.
100%