(60 days)
No
The provided 510(k) summary does not mention AI, ML, deep learning, or any related terms in the device description, intended use, or performance studies.
No.
The device is used to perform diagnostic studies and provide imaging for guidance, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "used to perform diagnostic general ultrasound studies".
No
The device description explicitly details hardware components such as a mainframe system, LCD displays, keyboard, hard disk, DVD-RW drive, and ports, indicating it is a physical ultrasound system, not software only.
Based on the provided information, the Esaote's Model 6425 Ultrasound System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The intended use clearly states that the system is used to "perform diagnostic general ultrasound studies" and provides "imaging for guidance of biopsy and imaging to assist in the placement of needles". This describes a device used for in vivo (within the living body) imaging and guidance, not for testing samples in vitro (outside the living body).
- Device Description: The description details an ultrasound system with probes, displays, and storage capabilities, all consistent with an imaging device used on a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Esaote Model 6425 is an imaging device used directly on the patient.
N/A
Intended Use / Indications for Use
Esaote's Model 6425 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, Laparoscopic 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)
IYN, IYO, ITX
Device Description
The model 6425 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Amplitude Doppler (AD), Tissue Enhancement Imaging (TEI), Multi View (MView), Tissue Velocity Mapping (TVM), Color Flow Mapping (CFM), Pulse Wave Doppler, 3D and 4D.
Model 6425 is equipped with a free orientable LCD Color Display were acquired images and advanced images are shown. Model 6425 is also equipped with a height adjustable/rotating keyboard.
A second LCD Display for additional controls and mode-depending keys, includes touch screen technology and is integrated in the control panel.
Model 6425 can drive phased (PA), convex array (CA), linear array (LA) probes, Doppler probes and Volumetric probes.
Model 6425 is equipped with an internal Hard Disk and with a 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
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal, Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, Urologic
Indicated Patient Age Range
Adult, Pediatric, Neonatal, Fetal
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)
The Model 6425 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 Ed. 3.0 (2005-12) Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. Corrigendum 1:2006 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. Corrigendum 2:2007 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2 Ed. 3.0 (2007-03) Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility - Requirements and Tests.
- IEC 60601-2-37 Ed. 2.0 (2007-08) Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
- NEMA Standards Publication UD 2-2004 Revision 3 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
- NEMA Standards Publication UD 3-2004 Revision 2 (R2009) Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.
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.
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 14, 2016
Esaote S.p.A % Allison Scott, RAC Managing Consultant Navigant Consulting, Inc. 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268
Re: K162290
Trade/Device Name: Model 6425 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: September 28, 2016 Received: September 29, 2016
Dear Ms. Scott:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Model 6425 Ultrasound System
Indications for Use (Describe)
Esaote's Model 6425 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, Laparoscopic 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Prescription Use Only Per 21 CFR 801 Part D Concurrence of
CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
aote SpA 6425 510(K)
Esaote 6425 Ultrasound System 510
| 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 | N:5, 7 |
| Fetal | N | N | N | N | N | N | N | N | N | N:5, 7 |
| Abdominal | N | N | N | N | N | N | N | N | N | N:5 |
| Intraoperative (Abdominal) | N | N | N | N | N | N | N | N | N | N:5 |
| Intraoperative Neurological | N | N | N | N | N | N | N | N | N | N:5 |
| Pediatric | N | N | N | N | N | N | N | N | N | N:5 |
| Small Organs [1] | N | N | N | N | N | N | N | N | N | N:5 |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N:5 |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N:5 |
| Cardiac [2] | N | N | N | N | N | N | N | N | N | N:5 |
| Transesophageal (Cardiac) | N | N | N | N | N | N | N | N | N | N:5 |
| Transesophageal (Non Cardiac) | N | N | N | N | N | N | N | N | N | N:5 |
| Transrectal | N | N | N | N | N | N | N | N | N | N:5, 7 |
| Transvaginal | N | N | N | N | N | N | N | N | N | N:5, 7 |
| Transurethral | N | N | N | N | N | N | N | N | N | N:5 |
| Intravascular | N | N | N | N | N | N | N | N | N | N:5 |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N:5 |
| Laparoscopic | N | N | N | N | N | N | N | N | N | N:5 |
| Musculo-skeletal Conventional [3] | N | N | N | N | N | N | N | N | N | N:5 |
| Musculo-skeletal Superficial [3] | N | N | N | N | N | N | N | N | N | N:5 |
| Other (Urological) | N | N | N | N | N | N | N | N | N | N:5, 7 |
6425
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| Intended use: Diagnostic ultrasound Imaging or fluid flow analysis of human body as follows: | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | Mode of Operations | Color Velocity | |||||||||
| Mapping (TVM) | Harmonic | ||||||||||
| Imaging (TEI) | Other (specify) | ||||||||||
| B | M | PWD | CWD | Color | |||||||
| Doppler | Amplitude | ||||||||||
| Doppler (AD) | Combined [4] | ||||||||||
| Ophthalmic | P | P | P | P | P | P | P | ||||
| Fetal | P | P | P | P | P | P | P | ||||
| Abdominal | P | P | P | P | P | P | P | P: 5 | |||
| Intraoperative (Abdominal) | P | P: 5 | |||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P: 5 | |||
| Small Organs [1] | P | P | P | P | P | P | P | P: 5 | |||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | P: 5 | ||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P: 5 | ||
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P | P: 5 | ||
| Other (Urological) | P | P | P | P | P | P | P | P | P: 5 | ||
| 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 | P | P | P | P | P | P | P | P: 5 | |||
| Small Organs [1] | P | P | P | P | P | P | P | P: 5 | |||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P: 5 | |||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P: 5 | |||
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P: 5 | |||
| Other (Urological) | |||||||||||
| Clinical Application | B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | ||||||||||
| Doppler | |||||||||||
| (AD) | Combined | ||||||||||
| [4] | Color Velocity | ||||||||||
| Mapping (TVM) | Harmonic | ||||||||||
| Imaging (TEI) | Other (specify) | ||||||||||
| Ophthalmic | |||||||||||
| Fetal | P | P | 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 | P: 5 | |||
| Transvaginal | P | P | P | P | P | P | P | P: 5 | |||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| [3] | |||||||||||
| Musculo-skeletal Superficial [3] | |||||||||||
| Other (Urological) | P | P | P | P | P | P | P | P: 5 | |||
| 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 | P: 5 | |||
| Abdominal | |||||||||||
| Intraoperative (Abdominal) | P | P | P: 5 | ||||||||
| 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 | P: 5 | |||
| Transvaginal | P | P | P | P | P | P | P | P: 5 | |||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial [3] | |||||||||||
| Other (Urological) | P | P | P | P | P | P | P | P: 5 | |||
| he TLC 3-13 probe is already clea | red via K161359 | ||||||||||
| IIH 6-18 | |||||||||||
| 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 | |||||||||||
| Fetal | P | P | P | P | P | P | P | P: 5 | |||
| Abdominal | P | P | P | P | P | P | P | P: 5 | |||
| Intraoperative (Abdominal) | P | P | P | P | P | P | P | P: 5 | |||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P: 5 | |||
| Small Organs [1] | P | P | P | P | P | P | P | P: 5 | |||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Transesophageal (Cardiac) | P | P | P: 5 | ||||||||
| Transesophageal (Non Cardiac) | P | P | P: 5 | ||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P: 5 | |||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional [3] | P | P | P | P | P | P | P | P: 5 | |||
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P: 5 | |||
| Other (Urological) | P | P | P | P | P | P | P | P: 5 | |||
| Mode of Operations | |||||||||||
| Clinical Application | B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | ||||||||||
| Doppler (AD) | Combined [4] | Color Velocity | |||||||||
| Mapping (TVM) | Harmonic | ||||||||||
| Imaging (TEI) | Other (sp | ||||||||||
| Ophthalmic | |||||||||||
| Fetal | P | P | P | P | P | P | P | P | P | P: 5 | |
| Abdominal | P | P | P | P | P | P | P | P | P | P: 5 | |
| Intraoperative (Abdominal) | P | P | P | P | P | P | P | P | P | P: 5 | |
| Intraoperative Neurological | |||||||||||
| LP 4-13 | |||||||||||
| ntended 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 | |||||||||||
| Fetal | |||||||||||
| Abdominal | P | P | P | P | P | P | P | P: 5 | |||
| 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 | P | P | P | P | P | P | P | P: 5 | |||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial [3] | |||||||||||
| Other (Urological) | |||||||||||
| he LP 4-13 probe is already cleared via K161359 | |||||||||||
| SB3123 | |||||||||||
| 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 | P | P | P | P | P | P | |||||
| Fetal | P | P: 5, 7 | |||||||||
| 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 | P: 5, 7 | |||
| Transvaginal | P | P | P | P | P | P | P | P: 5, 7 | |||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional [3] | |||||||||||
| Musculo-skeletal Superficial [3] | |||||||||||
| Other (Urological) | P | P | P | P | P | P | P | P: 5, 7 | |||
| Clinical Application | B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | ||||||||||
| Doppler | |||||||||||
| (AD) | Combined | ||||||||||
| [4] | Color Velocity | ||||||||||
| Mapping (TVM) | Harmonic | ||||||||||
| Imaging (TEI) | Other (specify) | ||||||||||
| Ophthalmic | P | P | |||||||||
| Fetal | P | P | |||||||||
| Abdominal | P | P | P | P | P | ||||||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P: 5 | ||||||
| Small Organs [1] | P | P | P | P | P: 5 | ||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P: 5 | |||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P: 5 | |||
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P: 5 | |||
| Other (Urological) | |||||||||||
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | |||||||||||
| Fetal | P | P | P | P | P | P | P | P: 5 | |||
| Abdominal | P | P | P | P | P | P | P | P: 5 | |||
| 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 | P: 5 | |||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P: 5 | |||
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P: 5 | |||
| Other (Urological) | P | P | P | P | P | P | P | P: 5 | |||
| he AC2541 probe is already cleared via K161350 | |||||||||||
| 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 | P: 5 | |||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P: 5 | |||
| Small Organs [1] | P | P | P | P | P | P | P | P: 5 | |||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | P | P | P | P | P | P | P | P: 5 | |||
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P: 5 | |||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional [3] | |||||||||||
| Musculo-skeletal Superficial [3] | |||||||||||
| Other (Urological) | |||||||||||
| 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 | P | P | P | P | P | P | P | P | P | P: 5 | |
| Fetal | P | P | P | P | P | P | P | P | P | P: 5 | |
| Abdominal | P | P | P | P | P | P | P | P | P | P: 5 | |
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P | P: 5 | |
| Small Organs [1] | P | P | P | P | P | P | P | P | P | P: 5 | |
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | P | P | P | P | P | P | P | P | P | P: 5 | |
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P: 5 | |
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P: 5 | |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P | P | P: 5 | |
| Other (Urological) | |||||||||||
| SL1543 | |||||||||||
| 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 | P | P | P | P | P | P | P | P: 5 | |||
| Abdominal | P | P | P | P | P | P | P | P: 5 | |||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P: 5 | |||
| Small Organs [1] | P | P | P | P | P | P | P | P: 5 | |||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | P | P | P | P | P | P | P | P: 5 | |||
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P: 5 | |||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P: 5 | |||
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P: 5 | |||
| Other (Urological) | |||||||||||
| The SL1543 probe is already cleared via K161250 | |||||||||||
| 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 | |||||||||||
| Small Organs [1] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | P | ||||||||||
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | ||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial [3] | |||||||||||
| Other (Urological) | |||||||||||
| he S2MCW probe in already olored wio K161350 | |||||||||||
| 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 | |||||||||||
| Small Organs [1] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | ||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial [3] | |||||||||||
| 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 | P | P | P | P | P | P | P | P | P: 5, 7 | ||
| Abdominal | P | P | P | P | P | P | P | P | P: 5, 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 [3] | |||||||||||
| Musculo-skeletal Superficial [3] | |||||||||||
| Other (Urological) | |||||||||||
| SHFCW intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | |||||||||||
| Clinical Application | Mode of Operations | ||||||||||
| 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 | |||||||||||
| Small Organs [1] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | ||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional [3] | |||||||||||
| Musculo-skeletal Superficial [3] | |||||||||||
| Other (Urological) | |||||||||||
| ST2612 | |||||||||||
| 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 | |||||||||||
| Small Organs [1] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Transesophageal (Cardiac) | P | P | P | P | P | P | P | P | P: 5 | ||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| [3] | |||||||||||
| Musculo-skeletal Superficial [3] | |||||||||||
| Other (Urological) | |||||||||||
| the ST2612 probe is already cleared via K161359 | |||||||||||
| 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 | P: 5 | |||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | P | P | P | P | P | P | P | P: 5 | |||
| Pediatric | |||||||||||
| Small Organs [1] | P | P | P | P | P | P | P | P: 5 | |||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | P | P | P | P | P | P | P | P: 5 | |||
| Musculo-skeletal Conventional [3] | |||||||||||
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P: 5 | |||
| Other (Urological) | |||||||||||
| SE3123 | |||||||||||
| 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 | P | P | P | P | P | P | P: 5 | ||||
| Fetal | 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 | P: 5 | |||
| Transvaginal | P | P | P | P | P | P | P | P: 5 | |||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional [3] | |||||||||||
| Musculo-skeletal Superficial [3] | |||||||||||
| Other (Urological) | P | P | P | P | P | P | P | P: 5 | |||
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | P | P | P | P | P | P | P | P | P | P: 5 | |
| Fetal | P | P | P | P | P | P | P | P | P | P: 5 | |
| Abdominal | P | P | P | P | P | P | P | P | P | P: 5 | |
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P | P: 5 | |
| Small Organs [1] | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | P: 5 |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | P: 5 |
| Cardiac [2] | P | P | P | P | P | P | P | P | P | P | P: 5 |
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | P: 5 |
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional [3] | |||||||||||
| Musculo-skeletal Superficial [3] | |||||||||||
| SP2442 | |||||||||||
| ntended 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 | |||||||||||
| (PD) | Combined | ||||||||||
| [4] | Color Velocity | ||||||||||
| Mapping (TVM) | Harmonic | ||||||||||
| Imaging (TEI) | Other (specify) | ||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P:5 | ||
| Small Organs [1] | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P:5 | ||
| Adult Cephalic | |||||||||||
| Cardiac [2] | P | P | P | P | P | P | P | P | P:5 | ||
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | P:5 | ||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional [3] | |||||||||||
| Musculo-skeletal Superficial [3] | |||||||||||
| Other (Urological) |
SI2C41
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as for
【2C41 probe is already cleared via K1613
ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﻌﺎﻣﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺘﺎﺑﻌﺔ ﺍﻟﻤﺘﺎﺑﻌﺔ ﺍﻟﻤﺘﺎﺑﻌﺔ ﺍﻟﻤﺘﺎﺑﻌ
Small Organs includes Breast, Thyroid
[2] Cardiac is Adult and Pediatric
N.Y.U. Langone Bl.
PW+CW+CEM
[4] Combined modes are: B+M+PW+CEM
LC COMBINATION INDEX, B, M, P, C, AND
LC COMBINATION INDEX, M, P, C, AND
[5] Compound Imaging (MView)
[6] Includes contrast (Cni) in Adult Cardiac for left ventricle opacification and
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THE FUTURE IS ALREADY HERE - IT'S JUST NOT VERY EVENLY DISTRIBUTED. - WILLIAM GIBSON
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
SCREENING FOR GENETIC MUTATIONS
IN BRCA1 AND BRCA2, AND OTHER CANCER PREDISPOSITION GENES
Myriad Genetic Services, Inc.
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFN
[5] Compound Imaging (NView)
N New Middeston, Fireviews Previous Price. Bidded under Appendas E
(3) Musicult end Personal Production March Manager Services
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LFO Smallcap Strategic Beta ETF (FOUS) is designed to provide investment results that, before fees and expenses, correspond generally to the price and yield performance of the LFO Smallcap Strategic Beta Index.
[[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
Combined modes are: B+M+PW+CW+CFM+F
[5] Compound Imaging (MVIEW), 1.1, 1.6, 1.8, 1.9, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 8.0, 8.1, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 8.8, 8.9, 9.0, 9.1, 9.2, 9.3, 9.4, 9.5, 9.6, 9.7, 9.8, 9.9, 10.0, 10.1, 10.2, 10.3, 10.4, 10.5, 10.6, 10.7, 10.8, 10.9, 11.0, 11.1, 11.2, 11.3, 11.4, 11.5, 11.6, 11.7, 11.8, 11.9, 12.0, 12.1, 12.2, 12.3, 12.4, 12.5, 12.6, 12.7, 12.8, 12.9, 13.0, 13.1, 13.2, 13.3, 13.4, 13.5, 13.6, 13.7, 13.8, 13.9, 14.0, 14.1, 14.2, 14.3, 14.4, 14.5, 14.6, 14.7, 14.8, 14.9, 15.0, 15.1, 15.2, 15.3, 15.4, 15.5, 15.6, 15.7, 15.8, 15.9, 16.0, 16.1, 16.2, 16.3, 16.4, 16.5, 16.6, 16.7, 16.8, 16.9, 17.0, 17.1, 17.2, 17.3, 17.4, 17.5, 17.6, 17.7, 17.8, 17.9, 18.0, 18.1, 18.2, 18.3, 18.4, 18.5, 18.6, 18.7, 18.8, 18.9, 19.0, 19.1, 19.2, 19.3, 19.4, 19.5, 19.6, 19.7, 19.8, 19.9, 20.0, 20.1, 20.2, 20.3, 20.4, 20.5, 20.6, 20.7, 20.8, 20.9, 21.0, 21.1, 21.2, 21.3, 21.4, 21.5, 21.6, 21.7, 21.8, 21.9, 22.0, 22.1, 22.2, 22.3, 22.4, 22.5, 22.6, 22.7, 22.8, 22.9, 23.0, 23.1, 23.2, 23.3, 23.4, 23.5, 23.6, 23.7, 23.8, 23.9, 24.0, 24.1, 24.2, 24.3, 24.4, 24.5, 24.6, 24.7, 24.8, 24.9, 25.0, 25.1, 25.2, 25.3, 25.4, 25.5, 25.6, 25.7, 25.8, 25.9, 26.0, 26.1, 26.2, 26.3, 26.4, 26.5, 26.6, 26.7, 26.8, 26.9, 27.0, 27.1, 27.2, 27.3, 27.4, 27.5, 27.6, 27.7, 27.8, 27.9, 28.0, 28.1, 28.2, 28.3, 28.4, 28.5, 28.6, 28.7, 28.8, 28.9, 29.0, 29.1, 29.2, 29.3, 29.4, 29.5, 29.6, 29.7, 29.8, 29.9, 30.0, 30.1, 30.2, 30.3, 30.4, 30.5, 30.6, 30.7, 30.8, 30.9, 31.0, 31.1, 31.2, 31.3, 31.4, 31.5, 31.6, 31.7, 31.8, 31.9, 32.0, 32.1, 32.2, 32.3, 32.4, 32.5, 32.6, 32.7, 32.8, 32.9, 33.0, 33.1, 33.2, 33.3, 33.4, 33.5, 33.6, 33.7, 33.8, 33.9, 34.0, 34.1, 34.2, 34.3, 34.4, 34.5, 34.6, 34.7, 34.8, 34.9, 35.0, 35.1, 35.2, 35.3, 35.4, 35.5, 35.6, 35.7, 35.8, 35.9, 36.0, 36.1, 36.2, 36.3, 36.4, 36.5, 36.6, 36.7, 36.8, 36.9, 37.0, 37.1, 37.2, 37.3, 37.4, 37.5, 37.6, 37.7, 37.8, 37.9, 38.0, 38.1, 38.2, 38.3, 38.4, 38.5, 38.6, 38.7, 38.8, 38.9, 39.0, 39.1, 39.2, 39.3, 39.4, 39.5, 39.6, 39.7, 39.8, 39.9, 40.0, 40.1, 40.2, 40.3, 40.4, 40.5, 40.6, 40.7, 40.8, 40.9, 41.0, 41.1, 41.2, 41.3, 41.4, 41.5, 41.6, 41.7, 41.8, 41.9, 42.0, 42.1, 42.2, 42.3, 42.4, 42.5, 42.6, 42.7, 42.8, 42.9, 43.0, 43.1, 43.2, 43.3, 43.4, 43.5, 43.6, 43.7, 43.8, 43.9, 44.0, 44.1, 44.2, 44.3, 44.4, 44.5, 44.6, 44.7, 44.8, 44.9, 45.0, 45.1, 45.2, 45.3, 45.4, 45.5, 45.6, 45.7, 45.8, 45.9, 46.0, 46.1, 46.2, 46.3, 46.4, 46.5, 46.6, 46.7, 46.8, 46.9, 47.0, 47.1, 47.2, 47.3, 47.4, 47.5, 47.6, 47.7, 47.8, 47.9, 48.0, 48.1, 48.2, 48.3, 48.4, 48.5, 48.6, 48.7, 48.8, 48.9, 49.0, 49.1, 49.2, 49.3, 49.4, 49.5, 49.6, 49.7, 49.8, 49.9, 50.0, 50.1, 50.2, 50.3, 50.4, 50.5, 50.6, 50.7, 50.8, 50.9, 51.0, 51.1, 51.2, 51.3, 51.4, 51.5, 51.6, 51.7, 51.8, 51.9, 52.0, 52.1, 52.2, 52.3, 52.4, 52.5, 52.6, 52.7, 52.8, 52.9, 53.0, 53.1, 53.2, 53.3, 53.4, 53.5, 53.6, 53.7, 53.8, 53.9, 54.0, 54.1, 54.2, 54.3, 54.4, 54.5, 54.6, 54.7, 54.8, 54.9, 55.0, 55.1, 55.2, 55.3, 55.4, 55.5, 55.6, 55.7, 55.8, 55.9, 56.0, 56.1, 56.2, 56.3, 56.4, 56.5, 56.6, 56.7, 56.8, 56.9, 57.0, 57.1, 57.2, 57.3, 57.4, 57.5, 57.6, 57.7, 57.8, 57.9, 58.0, 58.1, 58.2, 58.3, 58.4, 58.5, 58.6, 58.7, 58.8, 58.9, 59.0, 59.1, 59.2, 59.3, 59.4, 59.5, 59.6, 59.7, 59.8, 59.9, 60.0, 60.1, 60.2, 60.3, 60.4, 60.5, 60.6, 60.7, 60.8, 60.9, 61.0, 61.1, 61.2, 61.3, 61.4, 61.5, 61.6, 61.7, 61.8, 61.9, 62.0, 62.1, 62.2, 62.3, 62.4, 62.5, 62.6, 62.7, 62.8, 62.9, 63.0, 63.1, 63.2, 63.3, 63.4, 63.5, 63.6, 63.7, 63.8, 63.9, 64.0, 64.1, 64.2, 64.3, 64.4, 64.5, 64.6, 64.7, 64.8, 64.9, 65.0, 65.1, 65.2, 65.3, 65.4, 65.5, 65.6, 65.7, 65.8, 65.9, 66.0, 66.1, 66.2, 66.3, 66.4, 66.5, 66.6, 66.7, 66.8, 66.9, 67.0, 67.1, 67.2, 67.3, 67.4, 67.5, 67.6, 67.7, 67.8, 67.9, 68.0, 68.1, 68.2, 68.3, 68.4, 68.5, 68.6, 68.7, 68.8, 68.9, 69.0, 69.1, 69.2, 69.3, 69.4, 69.5, 69.6, 69.7, 69.8, 69.9, 70.0, 70.1, 70.2, 70.3, 70.4, 70.5, 70.6, 70.7, 70.8, 70.9, 71.0, 71.1, 71.2, 71.3, 71.4, 71.5, 71.6, 71.7, 71.8, 71.9, 72.0, 72.1, 72.2, 72.3, 72.4, 72.5, 72.6, 72.7, 72.8, 72.9, 73.0, 73.1, 73.2, 73.3, 73.4, 73.5, 73.6, 73.7, 73.8, 73.9, 74.0, 74.1, 74.2, 74.3, 74.4, 74.5, 74.6, 74.7, 74.8, 74.9, 75.0, 75.1, 75.2, 75.3, 75.4, 75.5, 75.6, 75.7, 75.8, 75.9, 76.0, 76.1, 76.2, 76.3, 76.4, 76.5, 76.6, 76.7, 76.8, 76.9, 77.0, 77.1, 77.2, 77.3, 77.4, 77.5, 77.6, 77.7, 77.8, 77.9, 78.0, 78.1, 78.2, 78.3, 78.4, 78.5, 78.6, 78.7, 78.8, 78.9, 79.0, 79.1, 79.2, 79.3, 79.4, 79.5, 79.6, 79.7, 79.8, 79.9, 80.0, 80.1, 80.2, 80.3, 80.4, 80.5, 80.6, 80.7, 80.8, 80.9, 81.0, 81.1, 81.2, 81.3, 81.4, 81.5, 81.6, 81.7, 81.8, 81.9, 82.0, 82.1, 82.2, 82.3, 82.4, 82.5, 82.6, 82.7, 82.8, 82.9, 83.0, 83.1, 83.2, 83.3, 83.4, 83.5, 83.6, 83.7, 83.8, 83.9, 84.0, 84.1, 84.2, 84.3, 84.4, 84.5, 84.6, 84.7, 84.8, 84.9, 85.0, 85.1, 85.2, 85.3, 85.4, 85.5, 85.6, 85.7, 85.8, 85.9, 86.0, 86.1, 86.2, 86.3, 86.4, 86.5, 86.6, 86.7, 86.8, 86.9, 87.0, 87.1, 87.2, 87.3, 87.4, 87.5, 87.6, 87.7, 87.8, 87.9, 88.0, 88.1, 88.2, 88.3, 88.4, 88.5, 88.6, 88.7, 88.8, 88.9, 89.0, 89.1, 89.2, 89.3, 89.4, 89.5, 89.6, 89.7, 89.8, 89.9, 90.0, 90.1, 90.2, 90.3, 90.4, 90.5, 90.6, 90.7, 90.8, 90.9, 91.0, 91.1, 91.2, 91.3, 91.4, 91.5, 91.6, 91.7, 91.8, 91.9, 92.0, 92.1, 92.2, 92.3, 92.4, 92.5, 92.6, 92.7, 92.8, 92.9, 93.0, 93.1, 93.2, 93.3, 93.4, 93.5, 93.6, 93.7, 93.8, 93.9, 94.0, 94.1, 94.2, 94.3, 94.4, 94.5, 94.6, 94.7, 94.8, 94.9, 95.0, 95.1, 95.2, 95.3, 95.4, 95.5, 95.6, 95.7, 95.8, 95.9, 96.0, 96.1, 96.2, 96.3, 96.4, 96.5, 96.6, 96.7, 96.8, 96.9, 97.0, 97.1, 97.2, 97.3, 97.4, 97.5, 97.6, 97.7, 97.8, 97.9, 98.0, 98.1, 98.2, 98.3, 98.4, 98.5, 98.6, 98.7, 98.8, 98.9, 99.0, 99.1, 99.2, 99.3, 99.4, 99.5, 99.6, 99.7, 99.8, 99.9, 100.0]
N New Madesham Pirter Business of PDA: BiAdded under Appendas B
3) Musicult end Personal Production March Manager Armanda B
31 Museum en artista Mark Proveder Price Archives
[7] 3D/4D
8
1358 K16 Via Belvedere Clearte
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
110 Organic Matters Direct, Inc. Important for Soil and Plants
Sommaire Important Pour Sol et Plantes
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
Combined modes are: B+M+PW+CW+CFM+F
[5] Compound Imaging (MView)
N: Naveston In Freebedry Electronic of Pri-Alidded under Appenaux E
23 Murdina Malulu Status Previous Marcel Maria Maria Marian Marian Marine Marina Marina Marina Marina Mari
IT3D/4D
9
K18-013 probe is already cleared via K18-013.doc
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
[1] SCHEMATIC STRUCTURES BY BRANCH, "LAST", "FIRST", AND "TEST" VARIABLES
Organization Structure: Branch, Last, First, Test
- Cardiac Adult and Pediatric :
[13] Musculo Skeletal - Nerve Block
4] Combined modes are: B+M+PW+CW+CFM+E
[5] Compound Imaging (MicroView)
Now Madesson Art Fevel Bank Character Production Brander E
Bi Museum Artes Basic Brander Production March Andres Architection Andre
Bio Museum and Property Provided on Pro
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Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Cardiac
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
IL 4-13
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as
Other (Urological)
The IL 4-13 probe is already cleared via K16135
P: 5 P: 5
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Transvaginal
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Ti Taxall dication, & Personalxy, Pared Re PDA; Bitded under Appendis
(2) Caralia Simonologia Parted Portuges States
(2) Constitute - Nero Blombers
(2) Museum - Nerve Blomm
LLC Schematic Structure, Materials, and Test Protocols
- LLC Schematic Structure (Brace, Hinge, and Test Articles)
- Materials
- Test Protocols
- Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
4] Combined modes are: B+M+PW+CW+CFM+F
[5] Compound Imaging (MView)
[6] Includes contrast (CnTl) in Adult Cardiac for left ventricle opacification and
1
1
Visualization of the Motor Vehicular Environment
F1/3D/4D
11
PROBLEMS CURRENTLY COVERED VIA K1635
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
[1] Scherer, D., Bridwell, R., and Turk, G. "Example-Based Procedural Placement of Detail on Surfaces". In ACM Transactions on Graphics (TOG), 2012, 31, 4, 1-10.
2] Cardiac is Adult and Pediatric :
[13] Musculo Skeletal - Nerve Block
Combined modes are: A+B; A+N; B+N; A+B+N
[5] Compound Imaging (MVIEW)
[/2/3D/4D
12
K163528 probe is already cleared via K163528
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
-
Small Organochlorines Breast, Thyroid, Brain and Testicles
-
Cardiac is Adult and Pediatric
[13] Musculo Skeletal - Nerve Block
- R.V. DI. an
4] Combined modes are: B+M+PV
CW+CFM+
- Compound Imaging (NView)
- Includes septum (C.M.I.S.)
[1] 3D/4D
13
SL2325
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow
REVISED MODE IS THE OPTION THAT IS CURRENTLY OPEN FOR DISCUSSION.
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
Scientific and Technical Advances
11. Studies on Breast Thyroid Interactions
Organochlorine Pesticides and Breast Cancer: A Review
Small [E]
[2] Cardiac is Adult and Pediatric
[3]. Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM
[5] Compound Imaging (M-View)
N New Middeston, Fireviews Previous Price. Bidded under Appendas E
(3) Musicult end Personal Production March Manager Services
(3) Musicult and Proporto Cover March Productio
7T/3D/4D
14
AC2541
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow
The probe is already cleared via K16135
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
U.S. Special Operations Branch, Tropical and Pesticides
[E]
- Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
Bio. R.M. DUARTE
- Combined modes are: B+M+PW+CW+CFM+P
[b] Compound Imaging (MNVIEW)
(12) Includes volume rendering (ICST) in addition to surface rendering.
N New Jindeshow Privated on Pri-Airaded under Appenda B
31 Musicula Shault Shares Brand.
23 Musium e Mault Parts March Production Maria Marian Andreamand
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[7] 3D/4D
Prescription Use Only Per 21 CFR 801 Part D Concurrence
DRH, Office of In Vitro Diagnostics and Radiological Health (
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15
CONSIDERATIONS FOR ADOPTING AGILE IS SIMILAR TO ADOPTING ANY NEW TECHNOLOGY. SOME OF THE PROBLEMS ARE:
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
NATIONAL INSTITUTES OF HEALTH
Solicitation Number: RFQ-NHLBI-DBBS-2024-02
Title: "Restricted Competition for the NHLBI Biorepository, Sample Processing, and Analysis (BioPSA) Resource and Repository"
- Cardiac is Adult and Pediatric :
[3] Musculo Skeletal - Nerve Block
CONTAINS NOCS AND B. SP. CH. CHEM
- Compound imaging (LMVIEW)
- Multi-angle (S, M, L)
- Spatial (S, M, L)
N New Middeston, Fireviews Previous Price. Bidded under Appendas E
Bij Musicult And Port Production Production March March March March March Manager Manager
Ball Comments of
[7] 3D/4D
16
ARE IS CURRENTLY CLOSED. PLEASE VISIT K16.CC/135
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
SCHEMERS WEST BRANCH, INC.
- Thyroid Support and Rest
- Prostate Plus
- Brain Boost
- Organ Support
- Small Intesticles
2] Cardiac is Adult and Pediatric :
[3] Musculo Skeletal - Nerve Block
4] Combined modes are: B+M+PW+CW+CFM-
[5] Compound Imaging (MView)
Now Madesson Art Fevel Bank Character Production Brander E
Bi Museum Artes Basic Brander Production March Andres Architection Andre
Bio Museum and Property Provided on Pro
[12] 3D/4D
Prescription Use Only Per 21 CFR 801 Part D Concurrence
DRH, Office of In Vitro Diagnostics and Radiological Health (
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17
THIS REPORT IS BASED ON DATA CURRENT AS OF 11/15/2023. DATA IS SUBJECT TO CHANGE VIA REVISIONS.
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
Small Organic Molecules: Broad and Pesticides
[1]
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
+) Combined modes are: B+M+PV
CW+CFM+
[b] Compound Imaging (MVIEW)
(c) 1, 1/2, 1/4, 1/8, 1/16 ms, etc.
[7] 3D/4D
18
ARE 15 ACRES GENERALLY OPEN SPACE? YES, BUT THERE ARE EXCEPTIONS.
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
US Small Business Administration
SURETY BOND GUARANTEE PROGRAM
Information for Small and Emerging Contractors
[[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
- I.V. R/L 500 ml stat
CONSIDERED SEC, R.P.T., M.P.C.H., I.A.H.
[5] Compound Imaging (Mview)
[6] Ingludes controot (CTI) in
[7] 3D/4D
19
RESOLUTION: HIGHLY ORGANIZED, WELL-STRUCTURED, CLEARLY PRESENTED, EASY TO UNDERSTAND, WELL-WRITTEN
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
- Small Organic Molecules Include Sugars, Fatty Acids, Amino Acids, and Nucleotides
- Cardiac is Adult and Pediatric
- Cardiac is Adult, Pediatric
[3] Musculo Skeletal - Nerve Block
- Combined modes are: B+M+PW+CW+CFM+F
[15] Compound Imaging (Mew)
[7] 3D/4D
20
RESPECT BROKERS ALREADY OPERATING WITH CLIENTS.
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
SMALL OPTIONS INCLUDE: Tomatoes, Broccoli, Cauliflower, Spinach, and Potatoes
[[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
BMC Anesthesiology 2011, 11:14 http://www.biomedcentral.com/1471-2253/11/14
- Combined modes are: B+M+PW+CW+CFM+
[5] Compound Imaging (MView)
[7] 3D/4D
21
SCHOTT® BOROFLOAT® 33
Borosilicate Glass
Ready for new ideas
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
Small Organics Processes Branch, Biopesticides and Pollution Prevention Division
[2] Cardiac is Adult and Pediatric.
[3] Musculo Skeletal - Nerve Block
- Combined modes are: B+M+
W+CW+CFM+F
New Malleation in Previews Channel of Prid Einded under Appender B
23 Murdina Malay Previous March Stades under Appendes B
23 Marcula Prace Brander Proved Andres Productio
[7] 3D/4D
22
K1635135
Via Redacted
Clearly Cleaners
Property Address
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
[1] SCHUMANN, STRUMAS, BRENNAN, and TROTTIER: Sources and Restrictive Practices
[2] Cardiacs Adult and Pediatric
[13 Musculo Skeletal - Nerve Block
4] Combined modes are: B+M+PW+CW+CFM+
[5] Compound Imaging (MewView)
N New Hillening Pires Business of PDA. Bidded under Appendix B
(3) Murdina Balaika Maria Maria Maria Maria Maria Marian Marian Marian Marina Hora
(3) Comment masu (2017) Mark
[I7/3D/4D]
23
VIA REDONDA IS PROUD TO ANNOUNCE VIA K1635
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
US Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
+) Combined modes are: B+M+P+
CW+CFM+F
[5] Compound Imaging (MView)
N: Nav Maleston I I Previews Cases in Prav Sindes under Appenax E
Si Murdina Malul Services Maria Maria Maria Maria Maria Marian Marian Marina Harina
Bal Combination Masti
[1] 3D/4D
Prescription Use Only Per 21 CFR 801 Part D Concurrence
DRH, Office of In Vitro Diagnostics and Radiological Health (
saote SpA 6425 510(k)
Esaote 6425 Ultrasound System 510
24
SPORTS AND ENTERTAINMENT VIA BLOGS AND SOCIAL MEDIA PLATFORMS ARE INCREASINGLY CLEARLY DEFINED AS ESSENTIAL
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
[1] SCHMIDT-ROGERS INDICES BASED ON "LAST" BRENT CRUDE OIL PRICES
- Cardiac, Adult, and Pediatric
[3] Musculo Skeletal - Nerve Block
Combined modes are: B+M+PW+CW+CFM+F
[5] Compound Imaging (Myview Imaging, Mview, m)
N New Madesham Pirter Business of PDA: BiAdded under Appendas B
3) Musicult end Personal Production March Manager Armanda B
31 Museum en artista Mark Proveder Price Archives
[F13D/4D
25
SP2430
Other (Urological)
The SP2430 probe is already cleared via K161357
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
First Breeches
and Other Stories from Iran, inc.
HL Cardiacs Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
4] Combined modes are: B+M+PW+CW+CFM+P
[5] Compound Images : MView
11 New lindestion in Previously Craned by PDA: Bridded under Appendix E
12 Prediker in Arabi and Personal Pro
13 Posted on Archives Merce Brown Pro
10 Posted in Maria Briti
visualization of the left ventricle.
1713D4D
Prescription Use Only Per 21 CFR 801 Part D Concurrence of
DRH, Office of In Vitro Diagnostics and Radiological Health (Ol
ote SpA 6425 510(k)
Esaote 6425 Ultrasound System 510
26
the SP2/042 probe is already cleared via K161335
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
L.L.C. Summers, Byerly, Poston & Furr, P.A.
Attorneys and Counselors
Specialized Trial and Appellate Services
[2] Cardiac is Adult and Pediatric
[13] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM+P
[5] Compound Imaging (MView)
11 Service Arabeahany - Derrestourly PDAT Bender Appendix Printer
11 Marculos Multi - Increations
12 Museum e Museum - Preve Brown PD Microsoft Provincial opacification a
F1/3D/4D
27
S2MPW
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow
| Clinical Application | B | M | PWD | CWD | Mode of Operations | | | | Color Velocity
Mapping (TVM) | Harmonic
Imaging (TEI) | Other (specify) |
|----------------------------------|---|---|-----|-----|--------------------|------------------------------|-----------------|--|---------------------------------|---------------------------|-----------------|
| | | | | | Color
Doppler | Amplitude
Doppler
(PD) | Combined
[4] | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | P | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | | |
THIS SPONSORED SECTION IS BROUGHT TO YOU BY K1621353 VIA KKR161353
This profile is already cleared via KKR161353
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
[1] SCHIRMER, MOSES, PERL & HUGHES
Attorneys at Law
100 Park Avenue, 17th Floor
New York, NY 10017
- Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM+P
[5] Compound Imaging (Mview)
(1) ﺃﺧﺮ ﺍﻟﻤﺎﻧﻴﻮﻧﻴﺴﻴﺎﻥ ﺍﻟﻤﺠﺎﻧﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﺘﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺎﺑﻌﺔ ﺑﻤﻨﻄﻘﺔ
Visualization of the left ventricular endocardium
(21/25)/VR
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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 A. Siffredi, 58 16153 Genova Italy
Contact Person:
Allison Scott, Managing Consultant 317.228.8719 Office 317.228.8701 Fax allison.scott@navigant.com
Date:
September 28, 2016
807.92(a)(2)
- Trade Name: Model 6425 Ultrasound System
- Common Name: Ultrasound Imaging System
- Classification Name(s): Ultrasonic pulse Doppler imaging system 892.1550 Ultrasonic pulsed echo imaging system 892.1560 Diagnostic ultrasonic transducer 892.1570
- Classification Number: 90IYN, 90IYO, 90ITX
29
807.92(a)(3)
Predicate Device(s)
| Predicate | 510(k) | Device | Owner |
|---|---|---|---|
| Primary | K161359 | 6400 - MyLabSeven | Esaote S.p.A. |
| Reference | K141486 | 6420 - MyLabSix | Esaote Europe B.V. |
Additional substantial equivalence information is provided in the substantial equivalence comparison table.
Device Description
The model 6425 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Amplitude Doppler (AD), Tissue Enhancement Imaging (TEI), Multi View (MView), Tissue Velocity Mapping (TVM), Color Flow Mapping (CFM), Pulse Wave Doppler, 3D and 4D.
Model 6425 is equipped with a free orientable LCD Color Display were acquired images and advanced images are shown. Model 6425 is also equipped with a height adjustable/rotating keyboard.
A second LCD Display for additional controls and mode-depending keys, includes touch screen technology and is integrated in the control panel.
Model 6425 can drive phased (PA), convex array (CA), linear array (LA) probes, Doppler probes and Volumetric probes.
Model 6425 is equipped with an internal Hard Disk and with a 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 model 6400 is already cleared via K161359. The model 6420 is already cleared via K141486.
The purpose of this submission is to introduce a new ultrasound system, model 6425. The system is based on Esaote S.p.A., model 6400, previously cleared via K161359 and Esaote Europe, model 6420, previously cleared via K141486.
- No new applications are introduced.
- No new probes are added.
- No additional software capabilities added.
Model 6425, defined herein, combine the cleared features of Esaote S.p.A. model 6400 model and Esaote Europe model 6420.
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The 6425 model is a combination of 6420 model previously cleared version via K141486 and 6400 model, previously cleared version via K161359.
The Model 6425 is manufactured under an ISO 9001 and ISO 13485 certified quality system.
807.92(a)(5)
Intended Use(s)
Esaote's Model 6425 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, Laparoscopic 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's Model 6425 employs the same fundamental technological characteristics as its predicate devices. The Model 6425 is substantially equivalent to Esaote's Model 6400 already cleared via K161359 and Esaote Europe's Model 6420 already cleared via K141486.
- Clinical uses for which the Model 6425 is designed are equivalent to those of Model 6400, already cleared via K161359.
- . The Model 6425, Model 6400 and Model 6420 are designed to meet the IEC60601-1 and the IEC60601-2-37 safety requirements.
- . The Model 6425, Model 6400 and Model 6420 provides an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values.
- The Model 6425, Model 6400 and Model 6420 provide a similar measurements and analysis package, with equal accuracy and precision.
- The Model 6425, Model 6400 and Model 6420 have digital storage capabilities, including Network connectivity.
- The Model 6425 image modes are available on other FDA cleared ultrasound systems, for instance Model 6400 and Model 6420.
31
807.92(b)(1)
Summary of Non-Clinical Tests
The Model 6425 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 Ed. 3.0 (2005-12) Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. Corrigendum 1:2006 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. Corrigendum 2:2007 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2 Ed. 3.0 (2007-03) Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility - Requirements and Tests.
- IEC 60601-2-37 Ed. 2.0 (2007-08) Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
- · NEMA Standards Publication UD 2-2004 Revision 3 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
- · NEMA Standards Publication UD 3-2004 Revision 2 (R2009) Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.
807.92(b)(2)
Summary of Clinical Tests
No clinical tests were performed.
807.92(b)(3)
Conclusion
The Model 6425 is substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.