Who is the manufacturer of MYLABSIX ULTRASOUND SYSTEM?

Esaote Europe B.V. filed the 510(k) submission for MYLABSIX ULTRASOUND SYSTEM (K141486).

What is the FDA product code for MYLABSIX ULTRASOUND SYSTEM?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for MYLABSIX ULTRASOUND SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MYLABSIX ULTRASOUND SYSTEM?

MyLabSeven (K111302, K132231, K132466); MyLabFive (K083882).

Who can help prepare an FDA 510(k) submission like MYLABSIX ULTRASOUND SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MYLABSIX ULTRASOUND SYSTEM

K141486 · Esaote Europe B.V. · IYN · Jul 11, 2014 · Radiology

Device Facts

Record ID	K141486
Device Name	MYLABSIX ULTRASOUND SYSTEM
Applicant	Esaote Europe B.V.
Product Code	IYN · Radiology
Decision Date	Jul 11, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric, 3rd-Party Reviewed

Intended Use

Esaote's MyLabSix ultrasound system 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, and Other: Urologic. The system 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

MyLabSix is a mainframe ultrasound system for diagnostic general ultrasound studies. It processes signals from phased, convex, linear array, Doppler, and volumetric probes. Operating modes include B-Mode, Amplitude Doppler (AD), Tissue Enhancement Imaging (TEI), XView, Multi View (MView), Trapezoidal View (TP View), Tissue Velocity Mapping (TVM), RF-based Quality Intima Media Thickness (QIMT), Color Flow Mapping (CFM), and Pulse Wave Doppler. The system features a main LCD display and an integrated touch-screen control panel. Data is stored on internal hard disks, DVD-RW, or external media via LAN/USB. Used in clinical settings by healthcare professionals, the device provides real-time imaging to assist in biopsy, needle placement, and peripheral nerve blocks, aiding clinical diagnosis and procedural guidance.

Clinical Evidence

No clinical tests were performed. Substantial equivalence is supported by non-clinical bench testing, including acoustic output, biocompatibility, cleaning/disinfection, thermal, electromagnetic, and mechanical safety testing.

Technological Characteristics

Mainframe ultrasound system with phased, convex, linear, Doppler, and volumetric probes. Features LCD display with integrated touch-screen control panel. Connectivity via LAN/USB. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD-2, and NEMA UD-3. Software includes measurement and analysis packages. Sterilization/disinfection per manufacturer instructions.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in adult and pediatric patients for cardiac, vascular, abdominal, fetal, small organ, musculoskeletal, and urologic applications, including biopsy and needle guidance.

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

MyLabSeven (K111302, K132231, K132466)
MyLabFive (K083882)

Related Devices

K161168 — MyLabSix Ultrasound System · Esaote Europe B.V. · Sep 2, 2016
K162290 — MyLabSix CrystaLine · Esaote, S.p.A. · Oct 14, 2016
K051308 — MYLAB 70 ULTRASOUND IMAGING SYSTEM · Esaote, S.p.A. · Jun 1, 2005
K051837 — MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100 · Esaote, S.p.A. · Jul 20, 2005
K081794 — MODEL 7340 ULTRASOUND SYSTEM · Esaote, S.p.A. · Jul 10, 2008

Submission Summary (Full Text)

{0}------------------------------------------------ JUL 1 1 2014 K141486 page 1 of 4 ### 510(k) Summary MyLabSix Esaote Europe # 510(k) Summary The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 1807.92(a). 807.92(a)(1) ## Submitter Information Esaote Europe B.V. Philipsweg I 6227 AJ Maastricht The Netherlands Contact Person: Allison Scott, RAC 317.228.8719 Office 317.372.0276 Mobile allison.scott@navigant.com Date: January 20, 2014 807.92(a)(2) | Trade Name: | MyLabSix Ultrasound System | | |-------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------| | Common Name: | Ultrasound Imaging System | | | Classification Name(s): | Ultrasonic pulse Doppler imaging system Ultrasonic pulsed echo imaging system Diagnostic ultrasonic transducer | 892.1550 892.1560 892.1570 | | Classification Number: | 90IYN, 90IYO, 90ITX | | {1}------------------------------------------------ 510(k) Summary MyLabSix Esaote Europe ### 807.92(a)(3) ### Predicate Device(s) | K111302, K132231 and K132466 | MyLabSeven | Esaote SpA | |------------------------------|------------|--------------------| | K083882 | MyLabFive | Esaote Europe B.V. | Additional substantial equivalence information is provided in the following substantial equivalence comparison table. ### Device Description The MyLabSix is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, Amplitude Doppler (AD), Tissue Enhancement Imaging (TEI), XView, Multi View (MView). Trapezoidal View (TP View), Tissue Velocity Mapping (TVM), RF-based Quality Intima Media Thickness (QIMT) ,Color Flow Mapping (CFM) and Pulse Wave Doppler. The MyLabSix is equipped with a free orientable LCD Color Display were acquired images and advanced images are shown. A second LCD Display for additional controls and mode-depending keys, includes touch screen technology and is integrated in the control panel. The MyLabSix can drive phased (PA), convex (CA), linear array (LA) probes, Doppler probes and Volumetric probes. The MyLabSix is equipped with an internal Hard Disk and with an DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (Hard-Disk, PC, server) via a LAN/USB port. The MyLabSix is manufactured under an ISO 9001:2008 and ISO 13485:2003 certified quality system. {2}------------------------------------------------ 510(k) Summary MyLabSix Esaote Europe ### 807.92(a)(5) ## Intended Use(s) Esaote's MyLabSix ultrasound system is a mainframe ultrasound svstem 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, and Other: Urologic. The system 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. ### 807.92(a)(6) ### Technological Characteristics Esaote Europe B.V. believes that the MyLabSix is substantial equivalent to Esaote's MyLabSeven product (K111302. K132231 and K132466) and Esaote's MyLabFive (K083882). - · Clinical uses for which the MyLabSix is designed are equivalent to those cleared for Esaote's MyLabSeven and MyLabFive . - . - · The MyLabSix, Esaote's MyLabSeven and Esaote's MyLabFive are designed to meet the IEC60601-1 and the IEC60601-2-37 safety requirements. - · The MyLabSix, Esaote's MyLabSeven and Esaote's MvLabFive provides an Acoustic Output Display feature per AIUM / NEMA standards. with equivalent Ispta and MI maximal values. - · The MyLabSix, Esaote's MyLabSeven and Esaote's MyLabFive provides a similar measurements and analysis package, with equal accuracy and precision. - · The MyLabSix, Esaote's MyLabSeven and Esaote's MyLabFive have a digital storage capabilities, including Network connectivity. - · The MyLabSix image modes are available on other FDA cleared ultrasound systems. for instance Esaote's MyLabSeven and Esaote's MyLabFive. {3}------------------------------------------------ K141486 Page 4 of 4 510(k) Summary MyLabSix Esaote Europe 807.92(b)(1) # Summary of Non-Clinical Tests The MyLabSix has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic. and mechanical safety, and have been found to conform to the following medical device safety standards. - · IEC 60601-1 - · IEC 60601-1-2 - · IEC 60601-2-37 - · NEMA UD-3 Standard for Real time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment - · NEMA UD-2 Acoustic Output Measurement Standard for Diagnostic Ultrasound ### 807.92(b)(2) ### Summary of Clinical Tests No clinical tests were performed. ### 807.92(b)(3) ### Conclusion The MyLabSix is substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three arms or lines extending from the body. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 11, 2014 Esaote Europe B.V. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313 Rc: K141486 Trade/Device Name: MyLabSix Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN. IYO. ITX Dated: June 5, 2014 Received: June 9, 2014 Dear Mr. Job: 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. This determination of substantial equivalence applies to the following transducers intended for use with the MyLabSix Ultrasound System, as described in your premarket notification: | | Transducer Model Number | | |--------|-------------------------|--------| | AC2541 | SC3421 | SC3123 | | SE3123 | AL2442 | SL3332 | | SL1543 | SL3323 | SL3235 | | SP2730 | S2MCW | S5MCW | | SHFCW | SB2C41 | ST2612 | | IOT342 | | | 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 {5}------------------------------------------------ Page 2-Mr. Job 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) (2) 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. 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/ResourcesforYou/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. O'Hara for Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page. ### 510{k} Number (if known) ### K 141486 Device Name MyLabSix Ultrasound System ### Indications for Use (Describe) Esaote's MyLabSix ultrasound system is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiae, Peripheral Vascular. Neonatal Cephalic. Adult Cephalic. Small Organs, Musculoskelcial (Conventional and Superficial), Abdominal, I'etal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, and Other: Urologic. The system 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. Type of Use (Select one or both, as applicable) > 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) Michael D. O'Hara FORM FDA 3881 (9/13) Esaote Europe B.V. Page 1 of 19 MyLabSix Ultrasound System (301) 443-6740 Page 6 {7}------------------------------------------------ | Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |-----------------------------------|---|---|-----|-----|---------------|------------------------|--------------|------------------------------|------------------------|-----------------| | Ophthalmic | N | N | N | N | N | N | N | N | N | 5,7 | | Fetal | N | N | N | N | N | N | N | N | N | 5,7 | | Abdominal | N | N | N | N | N | N | N | N | N | S | | Intraoperative (Abdominal) | N | N | N | N | N | N | N | N | N | S | | Intraoperative Neurological | N | N | N | N | N | N | N | N | N | S | | Pediatric | N | N | N | N | N | N | N | N | N | S | | Small Organs [1] | N | N | N | N | N | N | N | N | N | S | | Neonatal Cephalic | N | N | N | N | N | N | N | N | N | S | | Adult Cephalic | N | N | N | N | N | N | N | N | N | S | | Cardiac [2] | N | N | N | N | N | N | N | N | N | S | | Transesophageal (Cardiac) | N | N | N | N | N | N | N | N | N | S | | Transesophageal (Non Cardiac) | N | N | N | N | N | N | N | N | N | S | | Transrectal | N | N | N | N | N | N | N | N | N | S | | Transvaginal | N | N | N | N | N | N | N | N | N | S | | Transurethral | N | N | N | N | N | N | N | N | N | S | | Intravascular | N | N | N | N | N | N | N | N | N | S | | Peripheral Vascular | N | N | N | N | N | N | N | N | N | S | | Laparoscopic | N | N | N | N | N | N | N | N | N | S | | Musculo-skeletal Conventional [3] | N | N | N | N | N | N | N | N | N | S | | Musculo-skeletal Superficial [3] | N | N | N | N | N | N | N | N | N | S | | Other (Urological) | N | N | N | N | N | N | N | N | N | S | 6420 N: New indication; P: Previously cleared by FDA; E:Added under Appendix E # Tcg9 and # Data # Processing # for # Machine # Learning # & Computer # Vision 2) Cardiac, Is Regular, Rate And Pattern. - **VILLA SKENÄS BLACK** - **ARCHIPELAGO** - **NORRPEN** TS. MACHINE SCREWS, SEMS - METRIC CLASS [4] Combined modes are: B+M+PW+CW+CFM+ # ISC Compound Imaging [Partial Summation] n New Indiesion: Previously classed by PDA: C.Added under Appendix E 11 Samuria Santar Metre Brand Translate 11 Samura Starter Black Provident Trouden 11 Paulus Starter Print PRODUCTION OF LYSINE BY FERMENTATION WITH CORYNEBACTERIUM GLUTAMICUM 73d/4d Prescription Use Only Per 21 CFR 801 Part D Concurrence of Center for Devices and Radiological Health (CDRH) {8}------------------------------------------------ | 1 | AC2541 | |----|--------| | 2 | SC3421 | | 3 | SC3123 | | 4 | SE3123 | | 5 | AL2442 | | 6 | SL3332 | | 7 | SL1543 | | 8 | SL3323 | | 9 | SL3235 | | 10 | SP2730 | | 11 | S2MCW | | 12 | S5MCW | | 13 | SHFCW | | 14 | SB2C41 | | 15 | ST2612 | | 16 | IOT342 | . . . . . . . . . : . . 1. September 19. 1. 1. · . · . . . . . . : · : . {9}------------------------------------------------ | Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows | | | | | | | | | | | |---------------------------------------------------------------------------------------------|----|----|-----|-----|----------------|--------------------------|----------------|------------------------------|-------------------------|-----------------| | | | | | | | | | | | | | Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [ ] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | | Ophthalmic | | | | | | | | | | | | Fetal | P | P | P | | P | P | P | | P | S | | Abdominal | P | P | P | | P | P | P | | P | S | | Intraoperative (Abdominal) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organs [1] | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac [2] | | | | | | | | | | | | Transesophageal (Cardiac) | | | | | | | | | | | | Transesophageal (Non Cardiac) | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | P | P | P | | P | P | P | | P | S | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional [3] | P | P | P | | P | P | P | | P | S | | Musculo-skeletal Superficial (3) | P | P | P | | P | P | | | P | S | | Other (Urological) | P | P | P | | P | P | P | | P | S | | | | | | | | | | | | | | Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify] | | Ophthalmic | | | | | | | | | | | | Fetal | P | P | P | | P | P | P | | P | S | | Abdominal | P | P | P | | P | P | P | | P | S | | Intraoperative (Abdominal) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | P | P | P | | P | P | P | | P | S | | Small Organs [1] | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac [2] | | | | | | | | | | | | Transesophageal (Cardiac) | | | | | | | | | | | | Transesophageal (Non Cardiac) | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | P | P | P | | P | P | P | | P | S | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | S | | Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | S | | Other (Urological) | P | P | P | | P | P | P | | P | S | | The SC3421 probe is already | | | | | | | | | | | | tended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows | | | | | | | | | | | | | | | | | | ode of Operation | | | | | | Haical Applicatio | 8 | 2 | PWD | CWD | Öoppk Color | aplikude Doppler (AD) | Combined 4 | Color Velocity Kapping (TVM | maging (TEI larmonic | Other (specify) | | Ophthalmic | | | | | | | | | | | | etal | N | N | N | | N | N | N | | 도 | S | | bdominal | K | L | k | | Al | n | N | | k | S | | ntraoperative (Abdomina | | | | | | | | | | | | ntraoperative Neurologic | | | | | | | | | | | | ediatric | d | c. | ﻟ | | d | d | d | | d | S | | mail Organs | d | 느 | - | | d | d | d | | ﺎ | 5 | | ronatal Cephali | d | d | e | | ਹੈ | ﺷ | L | | 시 | 5 | | dult Cephalic | | | | | | | | | | | | ardine [2] | la | t | r | | d | t | d | | ﮯ | S | | tansesophageal (Cardia | | | | | | | | | | | | ransesophageal (Non Card | | | | | | | | | | | | ransntcla | | | | | | | | | | | | ransvagina | | | | | | | | | | | | ransurethra | | | | | | | | | | | | ntravascular | | | | | | | | | | | | cripheral Vascular | 5 | ત | ನ | | d | d | d | | ત | S | | aparoscopic | | | | | | | | | | | | Musculo-skeletal Conventio ਲ | ﻄ | n | d | | d | d | d | | ರ್ಥ | 5 | | Musculo-akcietal Superficial | d | d | ਰ | | a | B. | d | | P | S | | Other (Urological | | | | | | | | | | | | The SC3123 probe is alread | | | | | | | | | | | AC2541 Intended us The AC254) probe is dread cleared via K132466 checked for branch BK1286 N: New indication: P: Previously cleared by FDA: E:Added under Appendix E Small Organs includes Breast. Thyroid and Testicles # South Carolina Department of Archives and History # Archives Inventory Series E2 Cardiac in Adult and Pediatric |2| CADAVER BOUGH AND FOLIAGE |3| Subtype Skeletal - Nerve Block P 14 Combined modea are: B+M+FW+CW-CFM [4] Combined modea are: B+M+FW+CW-CFM+PD Daniel Richard Iannuzzo ESC Compliance 11 करने के लिखा जा 1 मिस्सवादी र 1 Peter 2017 Senadal under Specifica 11 Contact and President 11 Contact and President 11 Contact and President 10 Compressional Previous C APPLICATION OF THE 713D/4D Prescription Use Only Per 21 CFR 801 Part D {10}------------------------------------------------ ni SC3421 cleared via K101605 N: New indication; P: Previously cleared by FDA; E:Added under App # SPECIFICATIONS **PRODUCT:** 8.18 inches tall **MATERIAL:** Ceramic **ORIGIN:** Made in China KCI Cardiac IS Adult and Pediatric RII Anesthesia Skeletal - Nerve Block 14) Massive casing. NOTE: Does not include base. 15) Combined modes are: D, M, PM, CV, CPM. US Army Medical Research and Materiel Command USAMRMC (Muriel) For 16 N: Newildlession in Revelation in PDA: E-Maded under Appendia E IA Caralia Sistema : Merce Braziles : Microsofia E IA Caralia Siscalla : Merce Brouper : IST Combination : Mer (7| 3D/41) f1 3D/4D Prescription Use Only Per 21 CFR 801 Part D Concurrence of Center for Devices and Radiological Health (CDRH) Esaote Europe B.V. . **B.V.** {11}------------------------------------------------ ಿಗೆ a . ... SC3123 The SC3123 probe is already cleared via K101605 and to be cleared via KIO 1605 and to cleared via this submission : New indication; P: Previously cleared by FDA; E:Added under Appendix 8 **CONSIDER A BEQUEST TO THE FRANCISCAN MISSIONARIES OF MARY** **L** 221 CEDAR S HOME WITH A COVERED PORCH & BACK YARD. 3 BEDROOM, 1 BATH, VINYL SIDING, SHINGLE ROOF, & CENTRAL HEAT & AIR. MAXIMUM DAILY INTAKE - ADULTS AND CHILDREN 4 OR MORE YEARS OF AGE: 1/2 Combined and mixed with water, milk or juice. Adkins, Wedmore & Yates Chartered Surveyors Commercial Property Consultants **ISC Compound Name | Standard Formula** K2 includes contrast VCH(TI) in Xdim index indication: A Previously Christian Crimical Chicated unter Appendix E (2) Carador and Personal Proved Proveles (2) Personal - Report We Comments (2) Power and Property \$\mathbb{R}^{3}\$ f13d+40 Esaote Europe B. {12}------------------------------------------------ | Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | | | | | | | |----------------------------------------------------------------------------------------------|---|---|-----|-----|--------------------|------------------------------|-----------------|----------------------------------|---------------------------|-----------------|--| | Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined (4) | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | | | Ophthalmic | | P | | | | | | | | | | | Fetal | | P | P | | P | P | P | | P | 5 | | | Abdominal | | | | | | | | | | | | | Intraoperative (Abdominal) | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Pediatric | | | | | | | | | | | | | Small Organs (1) | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac (2) | | | | | | | | | | | | | Transesophageal (Cardiac) | | | | | | | | | | | | | Transesophageal (Non Cardiac) | | | | | | | | | | | | | Transrectal | P | P | P | | P | P | P | | P | 5 | | | Transvaginal | P | P | P | | P | P | P | | P | 5 | | | Transurethral | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Peripheral Vascular | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | | Musculo-skeletal Superficial (3) | | | | | | | | | | | | | Other (Urological) | | | | | | | | | | | | | Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | Mode of Operations | | | | | | | Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler [AD] | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | | | Ophthalmic | | | | | | | | | | | | | Rectal | P | P | P | | P | P | P | | P | 5 | | | Abdominal | P | P | P | | P | P | P | | P | 5 | | | Intraoperative (Abdominal) | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Pediatric | P | P | P | | P | P | P | | P | 5 | | | Small Organs [1] | P | P | P | | P | P | P | | P | 5 | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac [2] | 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 | 5 | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal Conventional (3) | P | P | P | | P | P | P | | P | 5 | | | Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | 5 | | | Other (Urological) | | | | | | | | | | | | | Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | | | Ophthalmic | | | | | | | | | | | | | Fetal | N | N | N | N | N | N | N | N | N | 5 | | | Abdominal | N | N | N | N | N | N | N | N | N | 5 | | | Intraoperative (Abdominal) | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Pediatric | N | N | N | N | N | N | N | N | N | 5 | | | Small Organs [1] | N | N | N | N | N | N | N | N | N | 5 | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac [2] | N | N | N | N | N | N | N | N | N | 5 | | | Transesophageal (Cardiac) | | | | | | | | | | | | | Transesophageal (Non Cardiac) | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Transurethral | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Peripheral Vascular | N | N | N | N | N | N | N | N | N | 5 | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal Conventional [3] | N | N | N | N | N | N | N | N | N | 5 | | | Musculo-skeletal Superficial [3] | N | N | N | N | N | N | N | N | N | 5 | | | Other (Urological) | | | | | | | | | | | | | The SL-3332 probe is to be | | | | | | | | | | | | | Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined (4) | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | | | Ophthalmic | | | | | | | | | | | | | Fetal | | | | | | | | | | | | | Abdominal | P | P | P | | P | P | P | | P | 5 | | | Intraoperative (Abdominal) | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Pediatric | P | P | P | | P | P | P | | P | 5 | | | Small Organs [1] | P | P | P | | P | P | P | | P | 5 | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac [2] | 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 | 5 | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | 5 | | | Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | 5 | | | Other (Urological) | | | | | | | | | | | | | Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVMI) | Harmonic Imaging (TEI) | Other (specify) | | | Ophthalmic | | | | | | | | | | | | | Fetal | P | P | P | | P | P | P | P | P | S | | | Abdominal | P | P | P | | P | P | P | P | P | S | | | Intraoperative (Abdominal) | P | P | P | | P | P | P | P | P | S | | | Intraoperative Neurological | | | | | | | | | | | | | Pediatric | P | P | P | | P | P | P | P | P | S | | | Small Organs [1] | P | P | P | | P | P | P | P | P | S | | | Neonatal Cephalic | P | P | P | | P | P | P | P | P | S | | | Adult Cephalic | | | | | | | | | | | | | Cardiac [2] | N | N | N | | N | N | N | N | N | S | | | Transesophageal (Cardiac) | | | | | | | | | | | | | Transesophageal (Non Cardiac) | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Transurethral | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Peripheral Vascular | P | P | P | | P | P | P | P | P | S | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | S | | | Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | P | P | S | | | Other (Urological) | | | | | | | | | | | | | The SL3323 probe is already | | | | | | | | | | | | | Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | Mode of Operations | | | | | | | Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | | | Ophthalmic | | | | | | | | | | | | | Fetal | | | | | | | | | | | | | Abdominal | | | | | | | | | | | | | Intraoperative (Abdominal) | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Pediatric | N | N | N | | N | N | N | | N | 5 | | | Small Organs [1] | N | N | N | | N | N | N | | N | 5 | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac [2] | | | | | | | | | | | | | Transesophageal (Cardiac) | | | | | | | | | | | | | Transesophageal (Non Cardiac) | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Transurethral | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Peripheral Vascular | N | N | N | | N | N | N | | N | 5 | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal Conventional [3] | N | N | N | | N | N | N | | N | 5 | | | Musculo-skeletal Superficial [3] | N | N | N | | N | N | N | | N | 5 | | | Other (Urological) | | | | | | | | | | | | | The SI 2235 probe is to be | | | | | | | | | | | | | Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | Mode of Operations | | | | | | | Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | | | Ophthalmic | N | N | N | N | N | N | N | N | N | | | | Fetal | N | N | N | N | N | N | N | N | N | | | | Abdominal | N | N | N | N | N | N | N | N | N | | | | Intraoperative (Abdominal) | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Pediatric | N | N | N | N | N | N | N | N | N | | | | Small Organs [1] | | | | | | | | | | | | | Neonatal Cephalic | N | N | N | N | N | N | N | N | N | | | | Adult Cephalic | N | N | N | N | N | N | N | N | N | | | | Cardiac [2] | N | N | N | N | N | N | N…