LogoFDA 510(k) Search
K Number
K141486
Device Name
MYLABSIX ULTRASOUND SYSTEM
Manufacturer
ESAOTE EUROPE B.V.
Date Cleared
2014-07-11

(36 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
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.
More Information

K111302, K132231, K132466, K083882

Not Found

No
The document describes standard ultrasound imaging modes and features, with no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.

No
The device is described as an ultrasound system used to perform "diagnostic general ultrasound studies," indicating its purpose is to identify or characterize conditions rather than to treat them.

Yes

The "Intended Use / Indications for Use" section explicitly states that the system is "used to perform diagnostic general ultrasound studies." The "Device Description" also reiterates that it is "used to perform diagnostic general ultrasound studies."

No

The device description explicitly details hardware components such as a mainframe system, LCD displays, control panel, probes, hard disk, and DVD-RW drive, indicating it is a hardware-based ultrasound system with integrated software.

Based on the provided information, the Esaote MyLabSix ultrasound system is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • IVD devices are used to examine specimens taken from the human body. The intended use and device description clearly state that the MyLabSix is an ultrasound system used to perform diagnostic studies on the patient's body (e.g., Cardiac, Abdominal, Fetal, etc.). It does not analyze samples like blood, urine, or tissue outside the body.
  • The description focuses on imaging modalities and anatomical sites. This aligns with the function of an ultrasound system for visualizing internal structures, not for analyzing biological samples.

Therefore, the MyLabSix is a diagnostic imaging device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

90IYN, 90IYO, 90ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, Urologic.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

No clinical tests were performed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K111302, K132231, K132466, K083882

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

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 transducer892.1550
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 K132466MyLabSevenEsaote SpA
K083882MyLabFiveEsaote 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
AC2541SC3421SC3123
SE3123AL2442SL3332
SL1543SL3323SL3235
SP2730S2MCWS5MCW
SHFCWSB2C41ST2612
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 ApplicationBMPWDCWDColor DopplerAmplitude Doppler (AD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
OphthalmicNNNNNNNNN5,7
FetalNNNNNNNNN5,7
AbdominalNNNNNNNNNS
Intraoperative (Abdominal)NNNNNNNNNS
Intraoperative NeurologicalNNNNNNNNNS
PediatricNNNNNNNNNS
Small Organs [1]NNNNNNNNNS
Neonatal CephalicNNNNNNNNNS
Adult CephalicNNNNNNNNNS
Cardiac [2]NNNNNNNNNS
Transesophageal (Cardiac)NNNNNNNNNS
Transesophageal (Non Cardiac)NNNNNNNNNS
TransrectalNNNNNNNNNS
TransvaginalNNNNNNNNNS
TransurethralNNNNNNNNNS
IntravascularNNNNNNNNNS
Peripheral VascularNNNNNNNNNS
LaparoscopicNNNNNNNNNS
Musculo-skeletal Conventional [3]NNNNNNNNNS
Musculo-skeletal Superficial [3]NNNNNNNNNS
Other (Urological)NNNNNNNNNS

6420

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

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[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
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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

1AC2541
2SC3421
3SC3123
4SE3123
5AL2442
6SL3332
7SL1543
8SL3323
9SL3235
10SP2730
11S2MCW
12S5MCW
13SHFCW
14SB2C41
15ST2612
16IOT342

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9

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (AD)Combined [ ]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
Ophthalmic
FetalPPPPPPPS
AbdominalPPPPPPPS
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPS
Laparoscopic
Musculo-skeletal Conventional [3]PPPPPPPS
Musculo-skeletal Superficial (3)PPPPPPS
Other (Urological)PPPPPPPS
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (AD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify]
Ophthalmic
FetalPPPPPPPS
AbdominalPPPPPPPS
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPS
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPS
Laparoscopic
Musculo-skeletal ConventionalPPPPPPPS
Musculo-skeletal Superficial [3]PPPPPPPS
Other (Urological)PPPPPPPS
The SC3421 probe is already
tended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows
ode of Operation
Haical Applicatio82PWDCWDÖoppk
Coloraplikude Doppler (AD)Combined
4Color Velocity Kapping (TVMmaging (TEI
larmonicOther (specify)
Ophthalmic
etalNNNNNN도S
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Musculo-skeletal Conventio
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The SC3123 probe is alread

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cleared via K132466

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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

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E2 Cardiac in Adult and Pediatric

|2| CADAVER BOUGH AND FOLIAGE
|3| Subtype Skeletal - Nerve Block

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[4] Combined modea are: B+M+FW+CW-CFM+PD

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APPLICATION OF THE 713D/4D

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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

  1. Massive casing. NOTE: Does not include base.

  2. Combined modes are: D, M, PM, CV, CPM.

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12

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(AD)Combined
(4)Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other (specify)
OphthalmicP
FetalPPPPPP5
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs (1)
Neonatal Cephalic
Adult Cephalic
Cardiac (2)
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
TransrectalPPPPPPP5
TransvaginalPPPPPPP5
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 ApplicationBMPWDCWDColor DopplerAmplitude Doppler [AD]Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
Ophthalmic
RectalPPPPPPP5
AbdominalPPPPPPP5
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPP5
Small Organs [1]PPPPPPP5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]PPPPPPP5
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPP5
Laparoscopic
Musculo-skeletal Conventional
(3)PPPPPPP5
Musculo-skeletal Superficial [3]PPPPPPP5
Other (Urological)
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (AD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
Ophthalmic
FetalNNNNNNNNN5
AbdominalNNNNNNNNN5
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricNNNNNNNNN5
Small Organs [1]NNNNNNNNN5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]NNNNNNNNN5
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNNNNN5
Laparoscopic
Musculo-skeletal Conventional [3]NNNNNNNNN5
Musculo-skeletal Superficial [3]NNNNNNNNN5
Other (Urological)
The SL-3332 probe is to be
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(AD)Combined
(4)Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other (specify)
Ophthalmic
Fetal
AbdominalPPPPPPP5
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPP5
Small Organs [1]PPPPPPP5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]PPPPPPP5
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPP5
Laparoscopic
Musculo-skeletal ConventionalPPPPPPP5
Musculo-skeletal Superficial [3]PPPPPPP5
Other (Urological)
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(AD)Combined
[4]Color Velocity
Mapping (TVMI)Harmonic
Imaging (TEI)Other (specify)
Ophthalmic
FetalPPPPPPPPS
AbdominalPPPPPPPPS
Intraoperative (Abdominal)PPPPPPPPS
Intraoperative Neurological
PediatricPPPPPPPPS
Small Organs [1]PPPPPPPPS
Neonatal CephalicPPPPPPPPS
Adult Cephalic
Cardiac [2]NNNNNNNNS
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPPS
Laparoscopic
Musculo-skeletal ConventionalPPPPPPPPS
Musculo-skeletal Superficial [3]PPPPPPPPS
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 ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(AD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricNNNNNNN5
Small Organs [1]NNNNNNN5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNNN5
Laparoscopic
Musculo-skeletal Conventional [3]NNNNNNN5
Musculo-skeletal Superficial [3]NNNNNNN5
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 ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(AD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other (specify)
OphthalmicNNNNNNNNN
FetalNNNNNNNNN
AbdominalNNNNNNNNN
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricNNNNNNNNN
Small Organs [1]
Neonatal CephalicNNNNNNNNN
Adult CephalicNNNNNNNNN
Cardiac [2]NNNNNNNNN
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNNNNN
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)
The SP2730 probe is to be
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:Mode of Operations
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (AD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
Ophthalmic
Cranial
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]P
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
LaparoscopicP
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)
* SIMCW probe is already

: J A . ﺗ SE3123

nk SESTES I 23 166

N: New includes P: Previously cleard by FDA: E:Added under Appendix E
||Somall Organs includes Breast, Thyroid and Testicles
|2| Cardiac is Adult and Petiativ
|| Combined mod

CALIFORNIA
STATE PARKS
FOUNDATION
OUR MISSION
To protect and enhance California's state parks, ensuring their
beauty and accessibility for generations to come.

My Cardiac is Adult and Pediatric.

CALIFORNIA STATE UNIVERSITY, NORTHRIDGE

LA VIRGINIA SPEECH AND LANGUAGE CLINIC - Norris Block

  1. Combined modes are: B+N, B+CV, CV+CF

  2. COMBINED RULES OF C.E.R.M.Y. FC & Y.C.

  3. Combined Insurance Division

|| Commond Imaging (Mitiev)
|5) Compound Imaging (Mitiev)
|6) Includes contrast (CnTl) in Adult Cardiac for left ventricle opacification and
visualization of the left ventric

NUTRITION FACTS
Serving Size 1 Cup (228g)
Servings Per Container 4
Amount Per Serving
Calories 260 Calories from Fat 120
% Daily Value*
Total Fat 13g 20%
Saturated Fat 5g 25%
Trans Fat 2g
Cholesterol 55mg 18%
Sodium 660mg 28%
Total Carbohydrate 31g 10%
Dietary Fiber 0g 0%
Sugars 5g
Protein 5g
Vitamin A 4% • Vitamin C 2%
Calcium 15% • Iron 4%

  • Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs:
    Calories: 2,000 2,500
    Total Fat Less than 65g 80g
    Sat Fat Less than 20g 25g
    Cholesterol Less than 300mg 300mg
    Sodium Less than 2,400mg 2,400mg
    Total Carbohydrate 300g 375g
    Dietary Fiber 25g 30g
    Calories per gram:
    Fat 9 • Carbohydrate 4 • Protein 4

[7] 3D/4D

F1 3D/4D

13

AL2442

The AL2442 probe is alread
cleared via K132466

MOLTEN METAL

N: New Microsian change should PDA: Encard under Angendia And
Sil Museum Shares Breatures Archives Marine epacitment and
Sil Museum Sheers Bronders Comments epacificantes an

CAUTION: READ THE INSTRUCTIONS BEFORE INSTALLING AND USING THIS PRODUCT.

IMPORTANT SAFETY INSTRUCTIONS

SAVE THESE INSTRUCTIONS

  1. Cardiac Adult and Pediatric

Musculo Skeletal - Nerve Block

15C. Controlled under are: R.M.P.M. CW. CCW. C.W.C.C.W. Other

Combined Dioxins etc. B(a)P, PCBs

ARC Comprehensive Examination & Registration, P.C.

Total includes 162 countries | China Only in Asia | Adult Content

visualization of the left ventricular endocardium by contrast echocardiography

f13D/4L

Esaote Europe B.V

14

・ " స్ SL3332

the SL3332 probe is to be cleared via this submission

cleared via this submission

E Spening Printers Brand Crance Le Province Marie Appender E
Previous Samurant Probecti
Previous Samurano Perior Provento
Previous Skircel - Heroe Bront Provider
Microsoft o

K12 Scholars Adult and Pediatrics

Radial Cutaneous Nerve | Common Peroneal Nerve | Tibial Nerve Block

14] Combined modes are: B+M+PW+CW+C

LET COOKIE DOUGH
CONTINUE ITS REIGN
AS THE MOST POPULAR
ICE CREAM FLAVOR

LIST OF COMPONENTS, INGREDIENTS

DESCRIPTION OF THE ACT, TRANSACTION, EVENT, OR CIRCUMSTANCE BEING REPORTED

f13d1

Prescription Use Only Per 21 CFFR 801 Parl D
oncurrence of Center for Devices and Radiological Health (CDRH)

Esaole Europe B.V

15

ﺗ SL1543

ther topology?
The SL1543 probe is already
cloned via K1(22)?

ne SL1343 proof is

http://www.ratent.net/.review.com/chouse-memore/media.org/w/index
12/ Cardinal shares and concellenter ander opendia.org
1/2/ Cardinal and Personal Convertioners and Provinc

CSUC
and
allied
brands

RI Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

All Combined modes are: B+N, B+C, N+C

SCS COMPOSITE PANEL SYSTEMS

Standard minimum (Chilean)

NATIONAL AERONAUTICS AND SPACE ADMINISTRATION
WASHINGTON, D.C. 20546

f13d74

16

SL3323

The SL3323 probe is already cleared via K101605 and to be

The SESSES | ProDC is and to
cleared via this submission

11 Seminer and Personal strema bereiner
11 Centralian and Peters Bronders
11 Constitution and Peters Divertises
11 Constitution and Peters Divertises and Periodation and
191

Sampling Strategy: A Potential Pitfall for Model and Metrics Evaluation

  1. Chronic vs. Adult and Pediatric

M. MURRAY SKENE, B.Sc. (Agr.) with I. Superintending Inspector, Dept. of Agriculture - Kenya Colony

ALL Combined Products, Inc. DBA APC, Inc. © 2023

BEL CANADIAN PARENTING ASSN. INC.
1415 LAWRENCE AVE. W. SUITE 203
TORONTO, ON M6L 1A1

  1. Compound Time Signatures

INSTRUCTIONS

  1. Read the entire application carefully.
  2. Complete all sections of the application.
  3. Sign and date the application.
  4. Submit the application to:

City of Santa Cruz
Planning and Community Development Department
701 Ocean Street, Santa Cruz, CA 95060
5. Include all required attachments.
6. Make sure your application is complete and accurate.
7. Incomplete applications will not be processed.
8. If you have any questions, please contact the Planning and Community Development Department at (831) 420-5100.

BUILDINGS COMPLETED
BUILDINGS UNDER CONSTRUCTION
BUILDINGS PLANNED
BUILDINGS CANCELLED

f13df4c

Prescription Use Only Per 21 CFR 801 Part D
Concurrence of Center for Devices and Radiological Health (CORH)

17

ni SL3235
Intended us

red via this submssion

N: New indication: P: Previously cleared by FDA: E:Added under

13 Servin desimale chanisment comments of the Maded under Appendia E
13 Centralian and Pediante Production Propendia E
13 Centralian and Pediante
10 Completeral and Primer P

LACT Care is Adult and Pediatric

Vitamin Skeletal, Heart, Blood
MINERALS FOR STRONG BONES, HEALTHY BLOOD AND IMMUNITY

LIST OF MEDICARE PART D PLAN
SPONSORS OFFERING SIMPLE
MEDICARE PART D PLANS
IN CALIFORNIA, BY REGION, PLAN
NAME, AND PLAN ID

total combined modes are: B.M., B.S., & B.A.

RS Components & Controls

Includes contrast in the skin (chiasm) at the optic nerve

Description for the APR Identifier Environmental Project

f13df41

Page 17

18

SP2730

cleared via this submission

ir Kouli Kasian Personaly Erans

ILLINOIS STATE EMPLOYEES RETIREMENT SYSTEM
OF ILLINOIS
1901 SOUTH FOURTH STREET, SPRINGFIELD, ILLINOIS 62794-9255

Is Carbolec what Adult and Pediatric
Cardiac Surgeons are saying?

13/ Musculo Skeletal - Nerve Block

ML Combined modes 3+B+C+M, P+M, P+C+M

CALIFORNIA

ASSOCIATION OF

REALTORS®

preservation of the left ventricular endocardium during surgical ventricular restoration and

F13D/4D

f13D/f4D

19

S2MCW

leared via K132466

its and station in Personals chance in Profit Eximided under Ameridae E
ral Museum Station and Persone
tal Museum Station and Persone
and Manufactures and Concerner Cover en

ALL STRAIN CYCLES INCLUDE FIRST PASS, TRIM, DRY, CURE, INSPECTION, AND PACKAGING

  1. Cardiac is Adult and Pediatric

(3) Huston-Schulz - Metric Black

  1. Combined modes are: B+M+PW+CW+C

ESI Compound Imaging (Method)

Key Technologies contrast (CM) with Adult Capture

SUPERVISION OF THE AIR SEMI-CONDUCTOR CHARACTERISTICS

1f3d41

Prescription Use Only Per 21 CFR 801 Part D
oncurrence of Center for Devices and Radiological Health (CDRH)

20

tended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Mode of Operations
linical ApplicatioIPWDCWDColormplitudeCombinedColor Velocity Mapping (TVM)Harmonic Maging (TEI)Other (specify)
DoppicDoppler (AD)દ્વનું
phthalmic
ctal
bdominal
Iraoperative (Abdomina
ntraoperative Neurologica
edialric
mill Organs I
ronatal Crphalic
dult Cephalic
ardiac (2)
ransesophageal (Cardia
ransesophageal (Non Cardia
massecta
ninsvaginal
ransurethra
niravascular
ripheral Vascular
aparoscopic
lusculo-skeletal Convention
lt
lusculo-skeleta! Superficial
Ther (Urological
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Mode of Operations
Clinical ApplicationBMPWDCWDColor DopplerAmplitude
Doppler
(ADI)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other (specify)
OphthalmicPPPPPPP5, 7
AbdominalPPPPPPP5, 7
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
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 ApplicationBMPWDCWDColor DopplerAmplitude Doppler (AD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
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
Laparoscopicp
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)
The SHFCW probe is already
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Mode of Operations
Clinical ApplicationBMPWDCWDColor DopplerAmplitude
Doppler
(AD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other (specify)
Ophthalmic
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)PPPPPPPS
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)
The ST2612 probe is already

SMCW

The S5MCW probe is already
cleared via K132466

: New indication; P: Previously cleared by FIDA; E:Added under Appendix

Purdue University
School of Electrical and Computer Engineering
ECE 438 Digital Signal Processing with Applications
Fall 2023
Midterm Exam 1
September 27, 2023

IDS and/or Southern States HERS, Home and Energy Raters

  1. Cardiac is Adult and Pediatric

COLORS TO REMAIN VIBRANT WASH AFTER WASH
(3) Wash in cold water. Hang to dry. Never Bleach. Never Iron.

ALL Combined Modes GFP
Combined Modes RFP
Combined Modes DAPI

PC Compatible Models 8088/86/286/386/486/Pentium/Pentium Pro/Pentium II/Celeron/AMD K5/K6/K6-2/K6-III/Athlon/Duron/Athlon XP/Athlon 64/Sempron/Opteron/Phenom/FX/Ryzen/Threadripper/EPYC

  1. Compound Images (Marvel)
  2. Includes material reprinted from Mighty Comics

में हिला प्रदेशकात करने में बिल्काम के लिए किसी किसी किसी को मिलता है।
13 किल्मान करना का सकते हैं और प्रभाव करते हैं कि महिला में बाद मिलता है कि महिला कि कार्यालय करते हैं

1F3D/4D

21

SB2C41

cleared via K132231

N: New indication; P: Previously cleared by FDA; E:Adocd under Appendix E
|| Small Organs includes Breas; Thyroid and Testicles
|| Cardiac is Adult and Pediatric
|3| Museulo

SPECIFICATIONS & FEATURES

  • 24" FULL HD (1920x1080) IPS DISPLAY
  • 165HZ REFRESH RATE
  • 1MS RESPONSE TIME
  • AMD FREESYNC™ PREMIUM
  • HDR READY
  • NIGHT VISION
  • WIDE COLOR GAMUT
  • FRAMELESS DESIGN
  • ANTI-FLICKER & LESS BLUE LIGHT
  • 178° WIDE VIEW ANGLE

KI Cardiac is Adult and Pediatric.

Hydro Skin Gel • NCRC Block

LCL CARNIVAL CRUISE LINE
REGISTERED ADDRESS: 3050 NW 112TH AVENUE, MIAMI, FL 33172-5830

LAI, COMPOSITE, IMAGES, R, G, B, NIR, SWIR1, SWIR2, NDVI, EVI, SAVI, NDWI, NDBI, Albedo, LST, Albedo_Annual

COMPUTING SURFACES
5.1. Introduction
5.2. Parametric Surfaces
5.3. Implicit Surfaces
5.4. Quadric Surfaces
5.5. Algebraic Surfaces
5.6. Polygon Meshes
5.7. Surface of Revolution
5.8. Sweep Surfaces
5.9. Bezier Curves and Surfaces
5.10. B-Spline Curves and Surfaces
5.11. NURBS Curves and Surfaces
5.12. Subdivision Surfaces
5.13. Fractal Surfaces
5.14. Visualization of Surfaces

|| Hustoids Skiller | NEW Life | PW+CW+CW+CW+CW+C
|| Combined model | M+CW+CW+CW+CW+CW+CW+CW+CH+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+

f13d/4a

f13d4/

Esaote Europe B.V.

Europe B.V.

MyLabSix Ultrasound System Page 16 of 19

22

SHFCW

cleared via K 132466

ri town in destionsh internative leanded under Appendix E
ral Marcules Mulli Shares Bronders
II Marcula Shaulan Alamania
I Marcula Shaulan Alam Clivet Clives and Pro
ISBN On

Small Organs Includes Bones, Tissues, and Muscles
Chapter 3: Nutrition and Fitness

12+ Cancer is Adult and Pediatric

[2] CARDIAC IS PURE RESEARCH
(3) Cardiac, Skeletal, Smooth Muscle, New Blood

  1. Brachial Plexus Block - INTERSCALENE Block
    (C5,C6,C7, +/- C8, +/- T1) - RAMEY/SWANSON

  2. Combined modes are: B+M+PW+CW+CF

ESI Compound Info
(Default: Positive)

structures combines in like (ICR) CH4 + CO2

Suspension of the left ventricular endocardial surface

FI 3D/4

Page 22

Esaole Europe B.V.

23

ﺎ ﺍﻟﻤﺘﻮﺍﻓﻖ ﺍﻟﻤﺘﻮﺍﻓﻖ ﺍﻟﻤﺘﻮﺍﺯ ﺍﻟﻤﺘﻮﺍﻓﻖ ﺍﻟﻤﺘﻮﺍﻓﻖ ﺍﻟﻤﺘﻮﺍﺯ ﺍﻟﻤﺘﻮﺍﺯ ﺍﻟﻤﺘﻮﺍﻓﻖ ﺍﻟﻤﺘﻮﺍﺯ ﺍﻟﻤﺘﻮﺍﺯ ﺍﻟﻤﺘﻮﺍﻓﻖ ﺍﻟﻤﺘﻮﺍﻓﻖ ﺍﻟﻤﺘﻮﺍﺯ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘ .............................................................................................................................................................................. ST2612

cleared via K 132466

in topalitet in Marin Pentrum in Perioria
III Marcula Maria Perioria Maria Maria
III Marcula Maria Perioria Maria Maria
III Marcula Maria Merri Divid-Currentes and Transa
Tr

  1. Cities of Refuge were cities where
  2. Cain's wife is Azura and Cain's

(3) Angela Skelley - Nurse Block
(5) Can't Wait With Nadia I Comics

WASHINGTON STATE
UNIVERSITY EXTENSION
WSU EXTENSION FORESTRY
FOREST STEWARDSHIP NOTES

IRC Combined Modes IRC, Inc.

FOR COMPOUNDING INTEREST (SYSTEMATIC WITHDRAWALS)

Behavioral Factors Contributing to Relationship Satisfaction in Romantic Relationships

ON 99.9% OF
STAPHYLOCOCCUS
AUREUS IN 10 MINUTES

F13D/41

Prescription Use Only Per 21 CFFR 801 Part D
Concurrence of Center for Devices and Radiological Health (CDRH)

.

24

ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical ApplicationMode of OperationsOther (specify)
BMPWDCWDColor DopplerAmplitude Doppler (AD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)
Ophthalmic
AbdominalPPPPPPP5
Intraoperative (Abdominal)PPPPPPP5
Intraoperative Neurological
PediatricPPPPPPP5
Small Organs [1]PPPPPPP5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPP5
Laparoscopic
Musculo-skeletal ConventionalPPPPPPP5
Musculo-skeletal Superficial [3]PPPPPPP5
Other (Urological)
The IOT342 probe is already

તર S alvsis of h a . Auto t imaning ...

IOT342

cleared via 1132466

E

tt: New indieding: Printer by Provide Microsoft E
III California Parted Brander Provides
III Caralia Satuli Sal Pediatria
III Kassile Sartuir La Pedata.
ISBN Compund linksing

SPECIFIC ABSORPTION RATE (SAR) INFORMATION
SAR tests are conducted using standard operating positions accepted by the FCC with the phone transmitting at its highest certified power level in all tested frequency bands, although the SAR is determined at the highest certified power level, the actual SAR level of the phone while operating can be well below the maximum value. Before a new model phone is available for sale to the public, it must be tested and certified to the FCC that it does not exceed the exposure limit established by the FCC, Tests for each phone are performed in positions and locations (e.g. at the ear and worn on the body) as required by the FCC.
For body worn operation, this model phone has been tested and meets the FCC RF exposure guidelines when used with an accessory designated for this product or when used with an accessory that contains no metal and that positions the handset a minimum of 1.0 cm from the body.
Non-compliance with the above restrictions may result in violation of RF exposure guidelines.

UI Cardiac is Adult and Pediatric

THE CERAMICS HOUR AND POTTERY PAINTING
NEW STUDIO OPENING SOON!

EST. 1953, SKETCH - REVS. DUCK

100% Cotton, Made in USA, RN131161, Cut

[4] Combined modes are: B+M+PW+CW+CFM+F

Compound Imaging Peripheral

(Technical Services)

[6] includes contrast (CnTl) in Adult Cardiac for left ventricle opacifi

LA. SINUS VENOUS ASDS WITH INTACT
SEPIUM (RARELY INFERIOR SINUS VENOUS ASDS)
ASSOCIATION OF THE PARTIAL ANOMALOUS PULMONARY DRAINAGE

|7| 3D/4D

Esaote Europe B.V.