MYLABSEVEN, MYLABALPHA
Device Facts
| Record ID | K111302 |
|---|---|
| Device Name | MYLABSEVEN, MYLABALPHA |
| Applicant | Esaote, S.p.A. |
| Product Code | IYN · Radiology |
| Decision Date | Jul 22, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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, and Other: Urologic. The 6400 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. Esaote's Model 7400 is a compact ultrasound system 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, and Other: Urologic. The 7400 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
The 6400 (mainframe) and 7400 (portable) are ultrasound imaging systems. They acquire ultrasound signals via various probes (phased, convex, linear, Doppler, volumetric) and process them into images for display on an LCD screen. Modes include B-Mode, M-Mode, TEI, XView, MView, TPView, Doppler, CFM, AD, and TVM. Operated by clinicians in clinical settings, the systems support data entry via Qwerty keyboard or touchscreen. Output is used for diagnostic imaging, biopsy guidance, needle placement, and peripheral nerve blocks. Wireless connectivity allows for data management. The systems provide real-time acoustic output indices to assist clinicians in maintaining safety during diagnostic procedures.
Clinical Evidence
No clinical tests were performed. Substantial equivalence is supported by bench testing, including acoustic output measurements, biocompatibility, cleaning/disinfection validation, and thermal/electromagnetic/mechanical safety testing per IEC and NEMA standards.
Technological Characteristics
Ultrasound imaging system; mainframe (6400) and portable (7400) form factors; LCD color display; supports phased, convex, linear, Doppler, and volumetric probes. Connectivity: Wireless/Wi-Fi. Safety standards: IEC 60601-1, IEC 60601-2-37, NEMA UD-2, NEMA UD-3. Quality system: ISO 9001:2000, ISO 13485.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in patients of all ages (pediatric to adult) for cardiac, vascular, abdominal, fetal, neonatal/adult cephalic, small organ (breast, thyroid, testicles), musculoskeletal (conventional/superficial, nerve block), and urologic applications.
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
- Esaote 7350 (K050326, K052805, K060827)
- Esaote 7340 (K081794, K091009)
- Esaote Europe 8100 (K101605)
Related Devices
- K132466 — MYLABSEVEN 6400, MYLABALPHA 7400 · Esaote, S.p.A. · Dec 4, 2013
- K161359 — 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System · Esaote, S.p.A. · Jul 19, 2016
- K132231 — MYLABSEVEN, MYLABALPHA · Esaote, S.p.A. · Nov 27, 2013
- K142077 — MYLABGAMMA · Esaote, S.p.A. · Sep 12, 2014
- K091009 — MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150 · Esaote, S.p.A. · May 18, 2009
Submission Summary (Full Text)
{0}------------------------------------------------
Traditional 510(k) Summary 6400-7400 System Esaote, S.p.A.
JUL 222 2011
KIII302
# Traditional 510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR¶807.92(a).
807.92(a){1)
Submitter Information
| Esaote S.p.A. |
|--------------------|
| Via Siffredi 58 |
| Genoa, Italy 16153 |
| Contact Person: | Allison Scott |
|-----------------|-----------------------|
| | 317.569.9500 x106 |
| | ascott@ansongroup.com |
| Date: | May 9, 2011 |
| 807.92(a)(2) | |
|--------------|--|
|--------------|--|
| Trade Name: | 6400 System |
|-------------------------|--------------------------------------------------|
| | 7400 System |
| Common Name: | Ultrasound Imaging System |
| Classification Name(s): | Ultrasonic pulse Doppler imaging system 892.1550 |
| | Ultrasonic pulsed echo imaging system 892.1560 |
| | Transducer, Ultrasonic, Diagnostic 892.1570 |
| Classification Number: | 90ΙΥΝ; 90ΙΥΟ; 901TX |
| 807.92(a)(3) | |
|--------------|--|
|--------------|--|
Predicate Device(s)
| K050326, K052805 and K060827 | 7350 | Esaote, S.p.A. |
|------------------------------|------|---------------------|
| K081794 and K091009 | 7340 | Esaote, S.p.A. |
| K101605 | 8100 | Esaote Europe, B.v. |
、..
{1}------------------------------------------------
Traditional 510(k) Summary 6400-7400 System Esaote, S.p.A.
### 807.92 (a)(4)
# Device Description
6400 is a mainframe system equipped with wheels allowing to move the system. 7400 is a portable system equipped with a handle. The system size and weight allow it to be carried using its handle. The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD) and Tissue Velocity Mapping (TVM). Both 6400 and 7400 are equipped with a LCD color display where acquired images and advanced image features are shown. Both 6400 and 7400 can drive Phased, Convex, Linear array, Doppler probes and Volumetric probes. 6400 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. On 7400 model the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. Both 6400 and 7400 systems are equipped with wireless capability. The 6400 and 7400 systems are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.
### 807.92(a)(5)
### Intended Use(s)
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, and Other: Urologic. The 6400 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.
Esaote's Model 7400 is a compact ultrasound system 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, and Other: Urologic. The 7400 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.
{2}------------------------------------------------
Traditional 510(k) Summarv 6400-7400 System Esaote, S.p.A.
### 807.92(a)(6)
# Technological Characteristics
The 6400 and 7400 systems employ the same fundamental technological characteristics as their predicate devices. The 6400 system is substantially equivalent to the Esaote 7350 cleared by FDA via K050326, K052805 and K060827. The 7400 system is substantially equivalent to the Esaote 7340 cleared by FDA via K081794 and K091009. Both 6400 and 7400 Wi-Fi connectivity is substantially equivalent to the Esaote Europe model 8100 cleared via K101605.
- Clinical uses for which respectively 6400 and 7400 are designed, are equivalent to those cleared for Esaote 7350 and 7340.
- · Both 6400 and 7400 are designed to meet the IEC60601-1 and IEC60601-2-37 safety requirements.
- Both 6400 and 7400 provide an Acoustic Output Display feature per AIUM / NEMA . standards, with equivalent Ispta and MI maximal values.
- Esaote 6400, 7400, 7350 and 7340 systems provide a similar measurements and analysis package.
- Esaote 6400, 7400, 7350 and 7340 systems have digital storage capabilities, including . Network connectivity.
- Esaote 7400, designed to be powered by battery, is equivalent to 7340 system, cleared . for battery powering via K081794.
### 807.92(b)(1)
### Summary of Non-Clinical Tests
The devices have 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 6060 1-2-37
- . 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 6400 and 7400 are substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and an abstract symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion. To the right of the text is an abstract symbol that resembles a stylized human figure or bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Esaote, S.p.A. % Ms. Allison Scott Regulatory Associate Anson Group 11460 N. Meridian Street, Suite 150 CARMEL IN 46032
JUL 2 2 2011
Re: K111302
Trade/Device Name: 6400 and 7400 Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 9, 2011 Received: May 9, 2001
Dear Ms. Scott:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your bookedetermined 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 micisate connibered problem to thay 20, 1997, 1997, 1998, 1998, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 19 Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to I cacial i oontrols provisions of the Act. The general controls provisions of the Act include the general connois provisions of the 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 I ms uccemination of succeans. Systems, as described in your premarket notification:
### Transducer Model Number
| SP2430 | S5MCW |
|--------|--------|
| LA523 | SHFCW |
| AL2442 | SE123 |
| AL2443 | TRT33 |
| AC2541 | ST2612 |
| S2MCW | |
{4}------------------------------------------------
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is classified (See above) into entrols. Existing major regulations affecting your device FDA it may be subject to such additional controls. Existing high to 895. In addition, FDA
can be found in the Code of Federal Regulations, Title 21, begin the Poderal Register can be found in the Couc of I caeral regarations, Fur device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuality of a substitive with other requirements of the Act
that FDA has made a determination that your device Force agencies. You must that FDA has made a delefinination that your arrived by other Federal agencies. You must or any Federal statutes and regulations administers of online ited to: registration and listing (21
comply with all the Act's requirements, including, but not ico requirement comply with all the Act s requirements, morialism of active requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sectron CFR Part 807); labeing (21 CFR Pat 801); good manationally and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat 820); and if applicable, forth in the quality systems (QS) regulation (DF OFFS 1000-1050.
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 This letter will anow you to begil marksming your device of your device to a legally marketed notification. The FDA iniding of substantial equivalise of this permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
s and the many and concerner and and and CDDH (OFF contract (15800 htm for If you desire specific advice for your devices of our care offices/ucm I 1589.htm for and offices/ucm I 1589.htm for a go to http://www.rda.gov/AboutrDA/Cchices Offices Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH) starter actifiestion" (21CFR Par the Center for Devices and Radionical 11ca. It of the storemarket notification" (21 CFR Part
note the regulation entitled, "Misbranding by reference under the MDR regulation note the regulation entitled, "Misolanding by relevelse to premiers" CFR Part 803), please go to
CFK Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office illtlp://www.ida.governetrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy, Ph.D. at (301) 796-6242.
Sincerely Yours,
Sincerely, Pearl,
Mary S Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
{5}------------------------------------------------
# Models 6400 and 7400
## Indications for Use
510(k) Number (if known):
Device Name:
6400 and 7400 Ultrasound Systems
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, and Other: Urologic. The 6400 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.
Esaote's Model 7400 is a compact ultrasound system 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, and Other: Urologic. The 7400 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.
Prescription Use AND/OR × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 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 Patil
Division Sign Off
tro Diagnostic Device
510(k) K111302
{6}------------------------------------------------
| 6400 | 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] | Color<br>Mapping |
| Ophthalmic | N | N | N | N | N | N | N | N |
| Fetal | N | N | N | N | N | N | N | N |
| Abdominal | N | N | N | N | N | N | N | N |
| Intraoperative<br>(Abdominal) | N | N | N | N | N | N | N | N |
| Intraoperative Neurological | N | N | N | N | N | N | N | N |
| Pediatric | N | N | N | N | N | N | N | N |
| Small Organs [1] | N | N | N | N | N | N | N | N |
| Neonatal Cephalic | N | N | N | N | N | N | N | N |
| Adult Cephalic | N | N | N | N | N | N | N | N |
| Cardiac [2] | N | N | N | N | N | N | N | N |
| Transesophageal (Cardiac) | N | N | N | N | N | N | N | N |
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| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD)<br>[4] | Combined<br>Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | |
|--------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|-------------------------------------|---------------------------------------------|---------------------------------|---------------------------|-----------------|
| Ophthalmic | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Fetal | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Abdominal | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Intraoperative (Abdominal) | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Intraoperative Neurological | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Pediatric | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Small Organs [1] | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Adult Cephalic | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Cardiac (2) | N | N | N | N | N | N | N | N | 5, 6, 7, 8, 9, 10 | |
| Transesophageal (Cardiac) | N | N | N | N | N | N | N | N {11} | 5, 6, 7, 8, 9, 10 | |
| Transesophageal (Non Cardiac) | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Transrectal | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Transvaginal | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Transurethral | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Intravascular | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Laparoscopic | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Musculo-skeletal Conventional [3] | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Musculo-skeletal Superficial [3] | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Other (Urological) | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| SP2430<br>Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD)<br>[4] | Combined | Color Velocity<br>Mapping (TVM) | Harmonic<br>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 | 5,6 |
| Small Organs [1] | | | | | | | | | | |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | 5,6 |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | 5,6 |
| Cardiac [2] | N | N | N | N | N | N | N | N | N(11) | 5, 6, 7, 8 |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | 5,6 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional<br>[3] | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>[4]<br>(PD) | Combined | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | | | P | P | | P | 6, 9, 10 | |
| Abdominal | P | P | | | P | P | | P | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | P | P | | | | |
| Small Organs [1] | P | P | | | P | P | | P | 5, 6, 9, 10 | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | P | P | | | P | P | | P | 6, 7, 8, 9, 10 | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | | | P | P | | P | 5, 6, 9, 10 | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional<br>[3] | P | P | | | P | P | | P | 5, 6, 9, 10 | |
| Musculo-skeletal Superficial [3] | P | P | | | P | P | | P | 5, 6, 9, 10 | |
| Other (Urological) | | | | | | | | | | |
| N: New indication; P: Previously cleared by FDA; E:Added under Appendix E | | | | | | | | | | |
| [1] Small Organs includes Breast, Thyroid and Testicles | | | | | | | | | | |
| (2) Cardiac is Adult and Pediatric | | | | | | | | | | |
| (3) Musculo Skeletal - Nerve Black | | | | | | | | | | |
| [4] Combined modes are: B+M+PW+CFM+PD | | | | | | | | | | |
| [5] Compass M-Mode (CMM) | | | | | | | | | | |
| [6] XView | | | | | | | | | | |
| [7] Stress | | | | | | | | | | |
| [8] Xstrain | | | | | | | | | | |
| [9] Compound Imaging (Mview) | | | | | | | | | | |
| [10] Trapezoidal View (TP-View) | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) [4] | Combined Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Fetal | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Abdominal | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Intraoperative (Abdominal) | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Intraoperative Neurological | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Pediatric | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Small Organs [1] | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Adult Cephalic | N | N | N | N | N | N | N | N | 5, 6, 7, 8, 9, 10 | |
| Cardiac [2] | N | N | N | N | N | N | N | N | 5, 6, 7, 8, 9, 10 | |
| Transesophageal (Cardiac) | N | N | N | N | N | N | N | N | 5, 6, 7, 8, 9, 10 | |
| Transesophageal (Non Cardiac) | N | N | N | N | N | N | N | N | 5, 6, 7, 8, 9, 10 | |
| Transrectal | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Transvaginal | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Transurethral | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Intravascular | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Laparoscopic | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Musculo-skeletal Conventional [3] | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Musculo-skeletal Superficial [3] | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Other (Urological) | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) [4] | Combined Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Fetal | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Abdominal | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Intraoperative (Abdominal) | N | N | N | N | N | N | N | N | 5, 6, 7, 8, 9, 10 | |
| Intraoperative Neurological | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Pediatric | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Small Organs [1] | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Adult Cephalic | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Cardiac [2] | N | N | N | N | N | N | N | N | 5, 6, 7, 9, 10 | |
| Transesophageal (Cardiac) | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Transesophageal (Non Cardiac) | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Transrectal | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Transvaginal | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Transurethral | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Intravascular | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Laparoscopic | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Musculo-skeletal Conventional [3] | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Musculo-skeletal Superficial [3] | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Other (Urological) | N | N | N | N | N | N | N | N | 5, 6, 9, 10 | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD)<br>[4] | Combined<br>Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | |
| Ophthalmic | N | N | N | N | N | N | N | N | | |
| Fetal | N | N | N | N | N | N | N | N | | |
| Abdominal | N | N | N | N | N | N | N | N | 5, 6, 11 | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | N | N | N | N | N | N | N | N | 5, 6, 11 | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | 5, 6, 11 | |
| Laparoscopic | N | N | N | N | N | N | N | N | 5, 6, 11 | |
| Musculo-skeletal Conventional<br>[3] | N | N | N | N | N | N | N | N | 5, 6, 11 | |
| Musculo-skeletal Superficial [3] | N | N | N | N | N | N | N | N | 5, 6, 11 | |
| Other (Urological) | N | N | N | N | N | N | N | N | 5, 6, 11 | |
| N: New indication; P: Previously cleared by FDA; E:Added under Appendix E | | | | | | | | | | |
:N xibiraddy צו אין אין אין אין אין אין אין אין אין אין אין אין איז איז איז איז אין
(Division Sign-Off)
Office of In Vitro of Radiological Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices
11130
510K
11
o biring biorning asosta ashrida da mana manaka biran marka bilang kali bira kira kari isi
1978 bilan kara mana manalari manaka marka izi kari isi
1944MTO+WO+WA+0 marka isa m Thysolic and Ticsticle
1. Consists of MAN and MACHINE
2. [5] Mirella Skriota - None Block
[3] Musculo Skeletal - Nerve Block
WASHINGTON - The Consumer Financial Protection Bureau (CFPB) is ordering TransUnion to pay \$15 million in penalties for violating a 2017 order. The CFPB found that TransUnion failed to ensure that its credit reporting affiliates were complying with the order, which required the company to provide consumers with accurate information about their credit scores and reports. The CFPB also found that TransUnion continued to use deceptive marketing practices to sell its credit monitoring products.
1. Combined modes are in operation.
[5] Compass in M-Mode (cont.)
Stress
stress
yield
Industry & Investment
Combined
Compound Image
Compound Imaging (M)
Perspective (Trapezoidal) View (TIP-View)
**PROS**
* Easy to use
* Good for beginners
* Lots of features
* Affordable
* Good customer support
a dolastican aprilization internet in the first in the many and the many of the lines.
1971 toping the 1970 to the 1970 this and the mind the mind the 11 lett 10 list.
1971
181. Proposition 181.
**125.00**
**125.00**
**Subtotal**
**Tax**
**Total**
1. **Introduction to the Valuation of Options**
2. **The Black-Scholes Model**
3. **Extensions of the Black-Scholes Model**
4. **Valuing American Options**
5. **The Greek Letters**
6. **Binomial Trees**
7. **Volatility**
8. **Exotic Options**
9. **Interest Rate Options**
10. **Credit Derivatives**
11. **Real Options**
12. **Employee Stock Options**
MINUTES COUNCIL
MINUTES Council Meeting
and Annual General Meeting
Canadian Council for the Arts
Media Arts Section
1. Introduction
2. The Idea
3. The Plan
4. The Execution
5. The Results
6. The Conclusion
7. The Future
8. The End
ອວກອາກວາກວຽດ ປີ ກ້ອງ 108 ກິງວາ 12 ກອງ ປຸໄກປີ ອະປີ ແດນປີຕຸ່ງຂອງ
(OVIO) ຂວາ່ງອຸດທຸກຄົນ ປີ ການປີ ການປີ ຄ.ສ. 1980 ເປັນປີ ຄ.ສ. 1980 ເປັນປີ 2000 ເມກາະສາ
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{8}------------------------------------------------
1
(Division of Radiological Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices
30
510K.
(WAS) are and wall and sales sales salows provents and the collection
6.2 Properties of the Fourier Transform
[2] Cardiac is adult and feeding.
[3] Musculo Skeletal - Nerve Blocks
[3] Musculo skeletal - Nerve Bloc
Content Made with Palmetto
**PROJECT**
**DESCRIPTION**
241 Combined modes are: B+M+PW+CW+CFM+
[4] Combined modes are: B+M+PW+CW+CFM+PL
[4] Combined modes are: B+M+PW+CW+CFM
4] Combined modes are: B+M+PW+CW+CFM-
ອນອາການປະກວດນ້ອຍ ອາຈານ
+CW+CFM
1 Combined modes are: B+M+PW+
CONTAINS 0% EXTENDED POLYSTYRENE
Cost-Benefit Analysis of P.L. 81-874 Impact Aid
CONTINUED
MINUTES SITE PLAN
RESOLUTION
CONTINUED
COMBINED AIR POLLUTION
MONITORING AND PREDICTION
COMBINED
MINUTES AS
REPORTED
BY
INSTRUCTOR
Combined models are 82% BETTER
GROUND PHYSICAL
NON-HAZARDOUS
Standard Ground Rate (4-10 Bus. Days)
ASSISTANT
MANAGER DA RULER
**COMBINED MIXED 97% K2R/DMC/C**
Combined modes are: B+M+PW+C
+CW+CF
Combined Model and Partial
BUTTERFLY
Standard models are: RS15PH140, RS15PH141, RS15PH142, RS15PH143, RS15PH144, RS15PH145, RS15PH146, RS15PH147, RS15PH148, RS15PH149, RS15PH150, RS15PH151, RS15PH152, RS15PH153, RS15PH154, RS15PH155, RS15PH156, RS15PH157, RS15PH158, RS15PH159, RS15PH160, RS15PH161, RS15PH162, RS15PH163, RS15PH164, RS15PH165, RS15PH166, RS15PH167, RS15PH168, RS15PH169, RS15PH170, RS15PH171, RS15PH172, RS15PH173, RS15PH174, RS15PH175, RS15PH176, RS15PH177, RS15PH178, RS15PH179, RS15PH180, RS15PH181, RS15PH182, RS15PH183, RS15PH184, RS15PH185, RS15PH186, RS15PH187, RS15PH188, RS15PH189, RS15PH190, RS15PH191, RS15PH192, RS15PH193, RS15PH194, RS15PH195, RS15PH196, RS15PH197, RS15PH198, RS15PH199, RS15PH200, RS15PH201, RS15PH202, RS15PH203, RS15PH204, RS15PH205, RS15PH206, RS15PH207, RS15PH208, RS15PH209, RS15PH210, RS15PH211, RS15PH212, RS15PH213, RS15PH214, RS15PH215, RS15PH216, RS15PH217, RS15PH218, RS15PH219, RS15PH220, RS15PH221, RS15PH222, RS15PH223, RS15PH224, RS15PH225, RS15PH226, RS15PH227, RS15PH228, RS15PH229, RS15PH230, RS15PH231, RS15PH232, RS15PH233, RS15PH234, RS15PH235, RS15PH236, RS15PH237, RS15PH238, RS15PH239, RS15PH240, RS15PH241, RS15PH242, RS15PH243, RS15PH244, RS15PH245, RS15PH246, RS15PH247, RS15PH248, RS15PH249, RS15PH250, RS15PH251, RS15PH252, RS15PH253, RS15PH254, RS15PH255, RS15PH256, RS15PH257, RS15PH258, RS15PH259, RS15PH260, RS15PH261, RS15PH262, RS15PH263, RS15PH264, RS15PH265, RS15PH266, RS15PH267, RS15PH268, RS15PH269, RS15PH270, RS15PH271, RS15PH272, RS15PH273, RS15PH274, RS15PH275, RS15PH276, RS15PH277, RS15PH278, RS15PH279, RS15PH280, RS15PH281, RS15PH282, RS15PH283, RS15PH284, RS15PH285, RS15PH286, RS15PH287, RS15PH288, RS15PH289, RS15PH290, RS15PH291, RS15PH292, RS15PH293, RS15PH294, RS15PH295, RS15PH296, RS15PH297, RS15PH298, RS15PH299, RS15PH300, RS15PH301, RS15PH302, RS15PH303, RS15PH304, RS15PH305, RS15PH306, RS15PH307, RS15PH308, RS15PH309, RS15PH310, RS15PH311, RS15PH312, RS15PH313, RS15PH314, RS15PH315, RS15PH316, RS15PH317, RS15PH318, RS15PH319, RS15PH320, RS15PH321, RS15PH322, RS15PH323, RS15PH324, RS15PH325, RS15PH326, RS15PH327, RS15PH328, RS15PH329, RS15PH330, RS15PH331, RS15PH332, RS15PH333, RS15PH334, RS15PH335, RS15PH336, RS15PH337, RS15PH338, RS15PH339, RS15PH340, RS15PH341, RS15PH342, RS15PH343, RS15PH344, RS15PH345, RS15PH346, RS15PH347, RS15PH348, RS15PH349, RS15PH350, RS15PH351, RS15PH352, RS15PH353, RS15PH354, RS15PH355, RS15PH356, RS15PH357, RS15PH358, RS15PH359, RS15PH360, RS15PH361, RS15PH362, RS15PH363, RS15PH364, RS15PH365, RS15PH366, RS15PH367, RS15PH368, RS15PH369, RS15PH370, RS15PH371, RS15PH372, RS15PH373, RS15PH374, RS15PH375, RS15PH376, RS15PH377, RS15PH378, RS15PH379, RS15PH380, RS15PH381, RS15PH382, RS15PH383, RS15PH384, RS15PH385, RS15PH386, RS15PH387, RS15PH388, RS15PH389, RS15PH390, RS15PH391, RS15PH392, RS15PH393, RS15PH394, RS15PH395, RS15PH396, RS15PH397, RS15PH398, RS15PH399, RS15PH400, RS15PH401, RS15PH402, RS15PH403, RS15PH404, RS15PH405, RS15PH406, RS15PH407, RS15PH408, RS15PH409, RS15PH410, RS15PH411, RS15PH412, RS15PH413, RS15PH414, RS15PH415, RS15PH416, RS15PH417, RS15PH418, RS15PH419, RS15PH420, RS15PH421, RS15PH422, RS15PH423, RS15PH424, RS15PH425, RS15PH426, RS15PH427, RS15PH428, RS15PH429, RS15PH430, RS15PH431, RS15PH432, RS15PH433, RS15PH434, RS15PH435, RS15PH436, RS15PH437, RS15PH438, RS15PH439, RS15PH440, RS15PH441, RS15PH442, RS15PH443, RS15PH444, RS15PH445, RS15PH446, RS15PH447, RS15PH448, RS15PH449, RS15PH450, RS15PH451, RS15PH452, RS15PH453, RS15PH454, RS15PH455, RS15PH456, RS15PH457, RS15PH458, RS15PH459, RS15PH460, RS15PH461, RS15PH462, RS15PH463, RS15PH464, RS15PH465, RS15PH466, RS15PH467, RS15PH468, RS15PH469, RS15PH470, RS15PH471, RS15PH472, RS15PH473, RS15PH474, RS15PH475, RS15PH476, RS15PH477, RS15PH478, RS15PH479, RS15PH480, RS15PH481, RS15PH482, RS15PH483, RS15PH484, RS15PH485, RS15PH486, RS15PH487, RS15PH488, RS15PH489, RS15PH490, RS15PH491, RS15PH492, RS15PH493, RS15PH494, RS15PH495, RS15PH496, RS15PH497, RS15PH498, RS15PH499, RS15PH500.
President Donald Trump
United States of America
Washington, DC
ROUND ORIGINAL
TO NEXT LOWER
TO NEXT HIGHER
RESERVOIR
VACUUM
HOSE
TO/FRM CHECK
VALVE
MAXIMO SAUCEDA TREJO DINA S. RUIZ QUIROZ
ARSENIO SKETCHAL - KEYE DUCK
MIXED SKETCH - HETIC DOCK
WASHINGTON EXCELSIOR - THE TRUE DUCK
URSUS EXCELSIOR : ARCTIC DUCK
B.M. All. & Co.
INSIDE OUTSIDE THE DUCK
BY BILL RICHARDSON
NASRIN ORCELAL - THE DUCA
Istanbul, Turkey
nasrin.orcelal@gmail.com
linkedin.com/in/nasrinorcelal
OSSIO SKETCHAL - Nerve Block
**SOLID SKETCHAL - NEW BLOCK**
**BASIC VOUCHER**
**WHITE DUCK**
SOUND ORCHESTRAL - NATIVE DUCK
1. NATIVE DUCK - MAIN - QUIET
2. NATIVE DUCK - MAIN - LOUD
3. NATIVE DUCK - MAIN - QUIET - REVERB
4. NATIVE DUCK - MAIN - LOUD - REVERB
5. NATIVE DUCK - TAIL - QUIET
6. NATIVE DUCK - TAIL - LOUD
7. NATIVE DUCK - TAIL - QUIET - REVERB
8. NATIVE DUCK - TAIL - LOUD - REVERB
WASHINGTON, D.C. - THE DUCK
ASSASSINS CREED III - WE'RE BACK
CLASSIC SKETCH - THE DUCK
KERATOS SKETCH - TOYCK BOX
IRSJD Skeletal - Nerve Block
Musculo Skeletal - Nerve Block
sculo Skeletal - Nerve Bo
Muscle Skeletal - Nerve - Blood
Scio Skeletal - Nerve Block
scald Skeletal - Nerve Block
C2C Skeletal - Nerve Block
Ankle Skeletal - Nerve Block
Musculo Skeletal - Nerve Bloc
Musculo Skeletal - Nerve Blood
cido Skeletal - Nerve Blo
IS ADULT AND EQUAL
Sala de Sesiones
Sala de Sesiones del Tribunal
Supremo de Justicia
Musculo Skeletal - Nerve
usculo Skeletal - Nerve B
MISSIO SKETCHAI - VERY DARK
MUSCLE SKELETAL - INJECTABLE SOLUTION
MARKETING STATISTICAL - WEBSITE TRACKER
ARSCHIO Skeletal - Nerve Block
Musculo Skeletal - Nerve Block
scielo Skeletal - Nerve Block
Ultrasound Skeletal - Nerve Block
fascia Skeletal - Nerve Block
cid Skeletal - Nerve Block
cid-Skeletal-Nerve-Fat
iscio Skeletal - Nerve
Isola della Scala - Verona
Ursula Skeldal - Natixis
Ischial Skeletal - Nerve
cola Skala Brasil - Nutrição
Brasileira para Cabelos
Musculo Skeletal - Nerve
culo
Skeletal - Nerve B
{9}------------------------------------------------
Mary S. Patil
(Division Sign-Off)
(Division Sign-Off)
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K111302
רב 222
1 £600 I X віт рэтвэ(Э ургиоглэтч
1 себол х
Prescription Use Only
{10}------------------------------------------------
AL2442
พงในปี อย ybod บุษย์ที่ 10 กิโลเมตร พงศ์ ที่มี 10 ตุที่เกิดเกี่ยวกับ อินคริว ค.ศ. 2445 ประเทศที่
สุด โจ จิจจพ
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
Pa
510K.
C
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
11/302
( พรรค ) พระราช พรรค พรรค พรรค ( พรรค พรรค ( พรรค) ( พรรคตรรดิ) ( พ.ศ. 1987) ( พ.ศ. 1987) ( พ.ศ. 1987) ( พ.ศ. 1987) ( พ.ศ. 1987) ( พ.ศ. 1987) ( พ.ศ. 1987) ( พ.ศ. 1987) ( พ.ศ
12. Cardiac is Adult and Pediatric.
115. Missio Skateboard - Navy/Black
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[4] Combined modes are: B+M+PW+CFM+PD
15 Compass M-Mode (CMN)
XYiew
Component in mass
stress
stress.
Xstrain
Compound Imaging (Mic
compound imaging & microscopy: Transversal View (TVP-View)
Compound Imaging (Microscopy) Tangential View (Top-View)
compound imaging layer. Horizontal View (TR-View)
compound imaging (MVI). Transaxial View (P-V)
comprising `Imaging`, `Functional Imaging`, `Tractography`, `Virtual View (TP-View)
Trap…
