(132 days)
Esaote's Model 6400 is a mainframe ultrasound system diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric and Other: Urologic. The 6400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
Esaote's Model 7400 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric and Other: Urologic. The 7400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
Model 6400 is a mainframe system equipped with wheels allowing them to move the system. Model 7400 is a portable system equipped with a handle. The system size and weight allow it to be carried using its handle. The primary modes of operation are for both models: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD) and Tissue Velocity Mapping (TVM). Both 6400 and 7400 are equipped with a LCD color display where acquired images and advanced image features are shown. Both 6400 and 7400 can drive Phased, Convex, Linear array and Doppler probes. 6400 control panel is equipped with a pull-out qwerty alphanumeric keyboard that allows data entry. On 7400 model the touchscreen has an emulation of the qwerty alphanumeric keyboard that allows data entry. Both 6400 and 7400 models are equipped with wireless capability. Model 7400 was designed to be powered by battery.
Both 6400 and 7400 have been cleared via K111302.
6400 and 7400 Upgrade, defined herein, combine the cleared features of both 6400 and 7400 systems with other new software capabilities, listed below:
-
- Management of motorized probes (Bi-Scan probes) that allow volumetric acquisition.
-
- Management of 3D/4D mode of operation.
-
- Management of the acquisition of consecutive ultrasound images on extended surface. The final image is composed of the consecutive frames placed side (Panoramic View or VPan).
The 6400 and 7400 Upgrades are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.
This 510(k) summary for the Esaote 6400 and 7400 Ultrasound Systems (K132231) indicates that no clinical tests were performed to establish acceptance criteria or demonstrate device performance.
Instead, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices and conformity to applicable medical device safety and performance standards.
Therefore, most of the requested information regarding acceptance criteria and performance studies, if they were based on clinical data, cannot be extracted from this document as such studies were explicitly stated as not performed.
However, I can extract information related to the device's technological characteristics and the non-clinical tests performed.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no clinical studies were performed, there are no specific performance metrics (e.g., sensitivity, specificity, accuracy) or quantitative acceptance criteria for diagnostic capability that can be reported from this document.
The acceptance criteria are implicitly based on:
- Substantial Equivalence: The new features and devices (6400 and 7400 Upgrades) are deemed substantially equivalent to previously cleared predicate devices (Esaote 6200, 7340, 6400, 7400 models). This means their performance is expected to be no worse than the predicate devices, which were already deemed safe and effective.
- Conformity to Safety Standards: The devices meet various international and national safety standards.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Technological Equivalence | Clinical Uses | Equivalent to predicate devices (K111302, K100931, K081794, K091009, K110688) |
| Bi-Scan probe management | Equivalent to predicate devices | |
| 3D/4D mode of operation | Equivalent to predicate devices | |
| Panoramic View (VPan) | Equivalent to predicate devices | |
| Safety Standards | IEC 60601-1 | Conforms to standard |
| IEC 60601-1-2 | Conforms to standard | |
| IEC 60601-2-37 | Conforms to standard | |
| NEMA UD-3 (Acoustic Output Display) | Conforms to standard, equivalent Ispta and MI maximal values to predicate | |
| NEMA UD-2 (Acoustic Output Measurement) | Conforms to standard | |
| Non-Clinical Tests | Acoustic Output | Evaluated and conforms |
| Biocompatibility | Evaluated and conforms | |
| Cleaning & Disinfection Effectiveness | Evaluated and conforms | |
| Thermal Safety | Evaluated and conforms | |
| Electromagnetic Safety | Evaluated and conforms | |
| Mechanical Safety | Evaluated and conforms |
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. No clinical test set data was used as "No clinical tests were performed." The submission relies on comparative data with predicate devices and non-clinical engineering tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. No clinical tests were performed, so no expert ground truth for a clinical test set was established as part of this submission.
4. Adjudication Method for the Test Set:
- Not Applicable. No clinical tests were performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is an ultrasound imaging system, not an AI-assisted diagnostic tool in the sense of software interpreting images for human readers. No MRMC comparative effectiveness study was done for AI assistance. The submission focuses on hardware and software feature upgrades to existing ultrasound systems.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is an ultrasound imaging system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For the purpose of establishing clinical performance, no ground truth data from clinical trials was used, as no clinical trials were performed. The "ground truth" for substantial equivalence is based on the cleared status and established safety and effectiveness of the predicate devices and conformity to engineering standards.
8. The sample size for the training set:
- Not Applicable. No clinical data was used for training purposes, as no clinical tests or AI/machine learning components requiring such training are described.
9. How the ground truth for the training set was established:
- Not Applicable. No clinical training set was used.
{0}------------------------------------------------
K12231
NOV 2 7 2013
Traditional 510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92.
807.92(a)(1)
Submitter Information
Esaote S.p.A. Via di Caciolle 15 Firenze, Italy 50127
Contact Person:
Allison Scott 317.569.9500 x106 ascott@ansongroup.com
Date:
June 24, 2013
807.92(a)(2)
Devices
| Common Name: | Ultrasound Imaging System |
|---|---|
| Trade Name: | 6400 Ultrasound System7400 Ultrasound System |
| Classification Name(s): | Ultrasound Pulse Doppler Imaging System 892.1550Ultrasound Pulse Echo Imaging System 892.1560Transducer, Ultrasonic, Diagnostic 892.1570 |
| Classification Number: | 90IYN, 90IYO, 90ITX |
807.92(a)(3)
| Device | Owner | 510(k) |
|---|---|---|
| 6400 | Esaote | K111302 |
| 7400 | ||
| 7340 | Esaote | K081794, K091009and K110688 |
| 6200 | Esaote | K100931 |
Predicate Device(s)
{1}------------------------------------------------
807.92(a)(4)
Device Description
Model 6400 is a mainframe system equipped with wheels allowing them to move the system. Model 7400 is a portable system equipped with a handle. The system size and weight allow it to be carried using its handle. The primary modes of operation are for both models: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD) and Tissue Velocity Mapping (TVM). Both 6400 and 7400 are equipped with a LCD color display where acquired images and advanced image features are shown. Both 6400 and 7400 can drive Phased, Convex, Linear array and Doppler probes. 6400 control panel is equipped with a pull-out gwerty alphanumeric keyboard that allows data entry. On 7400 model the touchscreen has an emulation of the qwerty alphanumeric keyboard that allows data entry. Both 6400 and 7400 models are equipped with wireless capability. Model 7400 was designed to be powered by battery.
Both 6400 and 7400 have been cleared via K111302.
6400 and 7400 Upgrade, defined herein, combine the cleared features of both 6400 and 7400 systems with other new software capabilities, listed below:
-
- Management of motorized probes (Bi-Scan probes) that allow volumetric acquisition.
-
- Management of 3D/4D mode of operation.
-
- Management of the acquisition of consecutive ultrasound images on extended surface. The final image is composed of the consecutive frames placed side (Panoramic View or VPan).
The 6400 and 7400 Upgrades are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.
807.92(a)(5)
Intended Use
Esaote's Model 6400 is a mainframe ultrasound system diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric and Other: Urologic. The 6400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
Esaote's Model 7400 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric and Other: Urologic. The 7400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
{2}------------------------------------------------
807.92(a){6)
Technological Characteristics
・・ [] "
The 6400 and 7400 Upgrades employ the same fundamental technological characteristics as their predicated devices. The 6400 Upgrade model is substantially equivalent to Esaote 6200 model cleared by FDA via K100931 and to Esaote 6400 model cleared by FDA via K111302. The 7400 Upgrade model is substantially equivalent to Esacte 7340 model cleared by FDA via K081794. K091009 and K110688 and to Esaote 7400 model cleared by FDA via K111302.
- · Clinical uses for which Esaote 6400 and 7400 models, cleared by FDA via K111302, are designed are not changed by 6400 and 7400 Upgrades, to be cleared via this submission.
- · Clinical uses for which Esaote 6400 and 7400 Upgrades are designed are equivalent to those of Esaote 6200 model, cleared via K100931, and of Esaote 7340 model, cleared via K081794. K091009 and K110688.
- Both 6400 and 7400 Upgrades for managing Bi-Scan probes are equivalent to those of Esaote 6200 model, cleared via K100931, and of Esaote 7340 model, cleared via K081794, K091009 and K110688.
- · Both 6400 and 7400 Upgrades for managing 3D/4D mode of operation are equivalent to those of Esaote 6200 model, cleared via K100931, and of Esaote 7340 model, cleared via K081794, K091009 and K110688.
- Both 6400 and 7400 Upgrades for managing acquisition of consecutive ultrasound images on extended surface are equivalent to those of Esaote 6200 model, cleared via K100931, and of Esaote 7340 model, cleared via K081794, K091009 and K110688.
- · Esaote 6400 Upgrade, 7400 Upgrade, 6400, 7400, 6200 and 7340 are designed to meet the IEC60601-1 and IEC60601-2-37 safety requirements.
- Esaote 6400 Upgrade, 7400 Upgrade, 6400, 7400, 6200 and 7340 ultrasound models provide an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values.
807.92(b)(1)
Summary of Non-Clinical Tests
The devices have been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic, and mechanical safety, and have been found to conform to the following medical device safety standards.
- IEC 60601-1 .
- . IEC 60601-1-2
- 1EC 6060 1-2-37 .
- . NEMA UD-3 - Standard for Real Time Display of Thermal and Mechanical Acoustic Qutput Indices on Diagnostic Ultrasound Equipment
- . NEMA UD-2 - Acoustic Output Measurement Standard for Diagnostic Ultrasound
{3}------------------------------------------------
807.92(b)(2)
Summary of Clinical Tests
No clinical tests were performed.
807.92(b)(3)
Conclusion
The 6400 and 7400 Upgrades are substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms reaching upwards. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 27, 2013
Esaote, S.p.A. % Ms. Allison Scott, Senior Consultant Anson Group 9001 Weslevan Road. Suite 200 INDIANAPOLIS IN 46268
Re: K132231
Trade/Device Name: 6400 Ultrasound System/MyLabSeven and 7400 Ultrasound System/MyLabAlpha Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 11, 2013 Received: November 13, 2013
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.
This determination of substantial equivalence applies to the following transducers intended for use with the MyLabSeven or MyLabAlpha, as described in your premarket notification:
Transducer Model Number
| SP2430 | S5MCW |
|---|---|
| SP2442 | SHFCW |
| LA435 | EC1123 |
| LA523 | SE3123 |
| AL2442 | TRT33 |
| AL2443 | ST2612 |
| AL2445 | BC441 |
| SL1543 | BC431 |
| AC2541 | BE1123 |
| S2MCW | SB2C41 |
{5}------------------------------------------------
Page 2-Ms. Scott
..............................................................................................................................................................................
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.lda.gov/Medical Devices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resources/orYou/Industrv/default.htm.
Sincerely yours.
Smh.7)
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}------------------------------------------------
Indications for Use
K132231 510(k) Number (if known):
Device Name:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6400 and 7400 Ultrasound Systems
Indications for Use:
Esacte's Model 6400 is a mainframe ultrasound system diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal. Pediatric and Other: Urologic. The 6400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
Esacte's Model 7400 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, and Other: Urologic. The 7400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Smh.7)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health K132231 510(k)
Page I of 23
{7}------------------------------------------------
6400
:
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler(PDI) | Combined(4) | Color VelocityMapping (TVM) | HarmonicImaging (TEI) | Other (specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | P | P | P. S. N. 6 | |
| Abdominal | P | P | P | P | P | P | P | P | P. S. N. 6 | |
| 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 | P | P | P | P | P | P | P | P | P. 5 | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P. 5 | |
| Cardiac (2) | P | P | P | P | P | P | P | y | P (7) | P. 5 |
| Transesophageal (Cardiac) | P | P | P | P | P | P | P | P | P. 5 | |
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | P | P | P | P | P | P | P | P. S. N. 6 | ||
| Transvaginal | P | P | P | P | P | P | P | P. S. N. 6 | ||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | 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 | P. 5 |
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
| | Small Organs includes Breast, Thyroid and Teaticles
|2| Cardiac is Adult and Pediatric
|3| Musculo Skeletal - Nerve Block
What is the difference between a
Molecule, Atom, and Element?
|-1| Combined modes are: B+M+PW+CW+CFM+PD
|5| Compound imaging (Mview)
16| 3D/4D
|7) Includes contrast (CnTi) in Adult Cardisc for left ventruite operiforation and visualization of the left ventricular endocardial border
Previously cleared via k 1 | 1 | 302
Proscription Uso Only Per 21 CFR 801 Part D Concurrence of Center for Devices and Radiological Haalth (CDRH)
.
{8}------------------------------------------------
7400
-- ".
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler(PD) | Combined[4] | Color VelocityMapping (TVM) | HarmonicImaging (TEI) | Other (specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | P | P | P. 5, N: 6 | |
| Abdominal | P | P | P | P | P | P | P | P | P. 5, N: 6 | |
| 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 | P | P | P | P | P | P | P | P | P. 5 | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P. 5 | |
| Cardiac [2] | P | P | P | P | P | P | P | P | P (7) | P. 5 |
| Transesophageal (Cardiac) | P | P | P | P | P | P | P | P | P | P. 5 |
| 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 | 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 |
N: New indication; P: Previously cleared by FDA; B:Added under Appendix E
| | | Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
|3| Musculo Skeleta| - Nerve Block
|4| Combined modes are: B.M.PW.CW.CFM+PD
|5] Compound Imaging |Mview|
|6| 3D/4D
..
|7| Includes contrast (CnTI) in Adult Cardiac for left ventricte opscification and
Previously cleared vin k l 1 | 302
{9}------------------------------------------------
SP2430 (6400 and 7400 systems)
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler(PD) | Combined(4) | Color VelocityMapping (TVM) | HarmonicImaging (TEI) | Other (specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | P | P | P.S | |
| Abdominal | P | P | P | P | P | P | P | P | P.S | |
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P.S | |
| Small Organs [1] | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P.S | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P.S | |
| Cardiac [2] | P | P | P | P | P | P | P | P | P(7) | P.S |
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P.S | ||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional[3] | ||||||||||
| Musculo-skeletal Superficial [3] | ||||||||||
| Other (Urological) |
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
| 1] Small Organs includes Breakt, Thyroid and Tealicles
|2| Cardiac is Adult and Pediatric
, 13) Musculo Skeletal - Nerve Block
|4| Combined modes are: B+M+PW+CW+CFM+PD
|5| Campaund Imaging (Mview)
lel 3D/4D
|7| Includes contrast (CnTl) in Adult Cardusc for Jeft ventnele operification and visualization of the left ventricular endocardial border
Previously cleared via kl 1 1302
{10}------------------------------------------------
SP2442 (6400 and 7400 systems)
| ---Modo of Operations | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clintes Application | B | M | PWD | CWD | ColorDappler | AmplitudeDopplerIPDI | Combined14) | Color VelocityMapping (TVM) | HarmonicImaging (TEI) | Other {specify) | |
| Ophthalmic | |||||||||||
| Felal | |||||||||||
| Abdominal | |||||||||||
| Untraoperative (Abdominal) | |||||||||||
| Intraoperative Neumlogica? | |||||||||||
| Pediatric | N | મ | N | મ | N | N | N | N | N | N 5 | |
| Small Organs | |||||||||||
| Neonatal Cephalic | N | ਮ | N | N | ਮ | 14 | N | N | N | મ - ક | |
| Adult Cephalic | |||||||||||
| Cardiac [2] | N | મ | N | મ | મ | મ | મ | N | H | મ ક | |
| Transcsophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intrasscular | |||||||||||
| Pengheral Vascular | N | મ | N | N | N | N | N | N | N | N 5 | |
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventionalti | |||||||||||
| Musculo-skeletal Superficial [3] | |||||||||||
| Other (Urological) | |||||||||||
| No New in disables of the county of the support of the program of the production of |
Intended use: Diagnostic ultrasound imaging or fluid flow snatysis of human body as follows:
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
[1] Small Organs includes Breast, Thyroid and Testicles
|2| Cardiac is Adult and Pediatric
|3] Musculo Skeletal - Nerve Block
|4] Combined modes are: B+M+PW+CW+CFM+PD
|5] Compound Imaging (Mview)
|6| 3D/4D
|7| includes contrast {CnTI) in Adult Cardiac for left ventrale opacification and
.
To be cleared through this aubmission
Prescription Use Only Per 21 CFR 801 Part D Concurrence of Center for Devices and Radiological Health (CDRH)
.
・
.
{11}------------------------------------------------
LA435 (6400 system)
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler(PDI) | Combined(4) | Color VelocityMapping (TVM) | HarmonicImaging (TEI) | Other (specify) | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P. S | |||
| Small Organs [1] | P | P | P | P | P | P | P | P S | |||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P. S | |||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional [3] | P | P | P | P | P | P | P | P S | |||
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P S | |||
| Other (Urological) |
Intended use: Diagnostic ultrasound imaging or fluid thow analysis of human body as follows:
N: New indication; P: Previously cleared by FDA; E:Added under Appendux E
| | Small Organs includes Breast, Thyroid and Tealeries
|2| Cardiac is Adult and Pedialric
|J| Musculo Skeletal - Nerve Block
H} Combined modes are: B+M+PW+CFM+PD
|5| Compound Imaging |Mview|
|6| 3D/4D
|7| Includes contrast (CnTi) in Adult Cardiae for left ventricte opecification and
・
Previously cleared via k1 10688
{12}------------------------------------------------
LA523 (6400 system)
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler(PD) | Combined[4] | Color VelocityMapping (TVM) | HarmonicImaging (TEI) | Other (specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | P | P S | ||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | E | E | E | E | E | E | E | E S | ||
| Small Organs [1] | P | P | P | P | P | P | P | P S | ||
| 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 S | ||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional[3] | P | P | P | P | P | P | P | P S | ||
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P S | ||
| Other (Urological) |
Intended use: Diagnostic utrasound imaging or fluid flow analysis of human body as follows:
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
| | Small Organs includes Breast, Thyroid and Testicles
(2) Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD
.
[5] Compound Imaging (Mview)
പ്ര 3D/4D
|7| Includes contrast (CnTi) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border
Previously cleared via k 1 1 1 302
{13}------------------------------------------------
AL2442 (6400 and 7400 systems)
.".
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical Application | Mode of Operations | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8 | M | PWD | CWD | ColorDoppler | AmplitudeDoppler(PD) | Combined데 | Color VelociryMapping (TVM) | Harmonicmaging (TEC) | Other {specify! | ||||||
| Ophthalmic | |||||||||||||||
| Fetal | ਦੇ | D | . E | દર | 13 | 8 | r | 8:5 | |||||||
| Abdaminal | P | P | P | P | P | P | P | 8.5 | |||||||
| Intraoperative (Abdominal) | |||||||||||||||
| Untraoperative Neurological | |||||||||||||||
| Pedialine | в | L | ் | 14 | E | E | t | દ ર | |||||||
| Small Organs {{} | P | P | 8 | P | P | P | P | P 5 | |||||||
| Neonatal Cephalic | |||||||||||||||
| Adult Cephalic | |||||||||||||||
| Cardiar 2) | P | P | P | P | P | P | P | 8 5 | |||||||
| Transesophageal (Cardiac) | |||||||||||||||
| Transcaophageal (Non Cardiac) . | |||||||||||||||
| Transrecial | |||||||||||||||
| Transvaginal | |||||||||||||||
| Transurethral | |||||||||||||||
| Intravascular | |||||||||||||||
| Penpherni Vascular | P | P | P | P | P | ﺎ ﺍﻟﻤ | P | P. S | |||||||
| Laparoscopic | |||||||||||||||
| Musculo-skeictal Conventionalિયા | P | P | P | P | P | P | P | 6.8 | |||||||
| Museulo-skeletal Superficial 3} | P | P | P | r | P | P | P | P. S | |||||||
| Other (Urological) |
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
| ! | Small Organs includes Breast, Thyroid and Testicles
|2| Cardia: is Adult and Pediatinc
|3} Musculo Skeletal - Nerve Block
|4| Combined modes are: B+M+PW+CFM+PD
|5| Compound Imaging (Mview)
{6} 3D/4D
(7) Includes contrast (CnTi) in Adult Cardiac for left ventrice operification and
visualization of the left ventneular endocardial border
Previounly cleared via K111302
{14}------------------------------------------------
AL2443 (6400 and 7400 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical Application | Mode of Operations | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler(PDI) | Combined[4] | Color VelocityMapping (TVM) | HarmonicImaging (TEI) | Other (specify) | |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | P | P.5 | ||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| 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] | P | P | P | P | P | P | P | P.5 | ||
| Musculo-skeletal Superficial (3) | P | P | P | P | P | P | P | P.5 | ||
| Other (Urological) |
N: New undication: P: Previously cleared by FDA: E:Added under Appendix E
(1) Small Organs includes Breast, Thyroid and Testicles
12} Cardiac is Adult and Pediatric
|3] Musculo Skeletal - Nerve Block
|4| Combined modes are: B+M+PW+CFM+PD
[5] Compound Imaging (Mview)
|6) 3D/4D
|7| Includes contrast (CnTi) in Adult Cardiac for left ventracle opacification and
visualization of the left ventricular endocardial border
Previously cleared via k ! ! ! ! 302
{15}------------------------------------------------
AL2445 (6400 and 7400 systems)
、
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical Annikation | B | M | PWD | CWD | Color Doppler(CFM) | AmplitudeDoppler(PWD) | Combined [3] | Color VelocityMapping (TVM) | HarmonicImaging (TEI) | Other(specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | N | N | N | N | N | N | N | N S | ||
| Small Organ [1] | N | N | N | N | N | N | N | N S | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (2) | ||||||||||
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | N: S | ||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional [2] | N | N | N | N | N | N | N | N: S | ||
| Musculo-skeletal Superficial [2] | N | N | N | N | N | N | N | N: S | ||
| Other (Urological) |
N: New indication: P: Previosuly cleared by FDA: E:Added under Appendix E
[ I | Small Organa includes Breast, Thyroid and Tealicles
| 2| Cardiac is Adult and Pediano
|3] Musculo Skeletal · Nerve Block
|4] Combined modes are: B+M+PW+CFM+PD
[5] Compound Imaging (Mview) [6] 3D/4D
{7| Includes contrass (CaTI) in Adult Cardine for left ventracle operification and
To be cleared through this
submission
{16}------------------------------------------------
SL1543 (6400 and 7400 systems)
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(CFM) | AmplitudeDoppler(PWD) | Combined [3] | Color VelocityMapping (TVM) | HarmonicImaging (TEI) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | N | N | N | N | N | N | N | N: 5 | ||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | N | N | N | N | N | N | N | N: 5 | ||
| Small Organ [1] | N | N | N | N | N | N | N | N: 5 | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (2) | N | N | N | N | N | N | N | |||
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | N: 5 | ||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional [2] | N | N | N | N | N | N | N | N: 5 | ||
| Musculo-skeletal Superficial [2] | N | N | N | N | N | N | N | N: 5 | ||
| Other (Urological) |
N: New Indication; P. Previosuly cleared by FDA; E:Added under Appendix E
| I | Small Organs includes Breast, Thyroid and Teaticles
|2| Cardiac is Adult and Pediatric
|3| Musculo Skeleta! · Nerve Block
[4] Combined modes are: B•M•PW•CPM•PD
|5} Compound Imaging (Mview) ിപ്പ് 3D/4D
|7| Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and
To be cleared through this submission
Prescription Use Only Per 21 CFR 801 Part D
{17}------------------------------------------------
| Mode of Operations | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler(PD) | Combined[4] | Color VelocityMapping (TVM) | HarmonicImaging (TEI) | Other (specify) | ||
| Ophthalmic | ||||||||||||
| Fetal | P | P | P | P | P | P | P | P | P. S | |||
| Abdominal | P | P | P | P | P | P | P | P. S | ||||
| Intraoperative (Abdominal) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Pediatric | ||||||||||||
| Small Organs [1] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac [2] | ||||||||||||
| Transesophageal (Cardiac) | ||||||||||||
| Transesophageal (Non Cardiac) | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P. S | ||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal Conventional[3] | P | P | P | P | P | P | P | P. S | ||||
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P. S | ||||
| Other (Urological) | P | P | P | P | P | P | P | P. S |
AC2541 (6400 and 7400 systems)
Intended use. Diagnostic utrasound imaging or fluid flow enabysis of human body as follows:
[I] Small Organs includes Breast, Thyroid and Testiclea
[2] Cardiac is Adult and Pedialric
|3| Muscuio Skeletal • Nerve Block
[4] Combined mades are: B+M+PW+CPM+PD
[5] Compound Imaging (Mview)
|6) 3D/4D
- includes contrast (CnTi) in Adult Cardiac for left ventricie opecification and
visualization of the left ventricular endocardial border
Previously cleared via k1111302
{18}------------------------------------------------
S2MCW (6400 and 7400 systems)
..
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical Application | Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler(PD) | Combined 4 | Color VelocityMapping (TVM) | HarmonicImaging (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 3 | |||||||||||
| Musculo-skeletal Superficial 3 | |||||||||||
| Other (Urological) |
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
| 1 | Small Organs includes Breast, Thyroid and Testicles
|2] Cardiac is Adult and Pedialric
|J| Musculo Skeletal - Nerve Black
|4| Combined modes are:
|5| Compound Imaging |Mviews
16| 3D/4D
[7] lociudes contrast (CnTT) in Adult Cardiac for left ventricle opecification and visualization of the left ventneular endocardial border
:
Previously cleared via k ! 1 1302
{19}------------------------------------------------
S5MCW (6400 and 7400 systems) Intended use: Disgnostic ultrasound imaging or fluid flow analysis of human body as follows:
· , ·
| Clinical Application | Mode of Operations | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| R | M | PWD | CWD | ColorDoppler | AmplitudeDoppler(PD) | Combined(4) | Color VelocityMapping (TVM) | HarmonicImaging (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) |
N: New indication: P: Previously cleared by FDA; E:Added under Appendux E
[1] Small Organs includes Breast, Thyroid and Tealicles
|2| Cardiac is Adult and Pediainc
|3| Musculo Skeletal · Nerve Block
|4] Combined modes are:
|5] Compound Imaging (Mview)
[6] 3D/4D
|7| Includes contrast (CnTi) in Adult Cardiac for left ventnele opecification and visualization of the left ventricular endocardial border
Previously cleared via k I I 1302
Prescription Use Only Per 21 CFR 801 Part D
Concurrence of Center for Devices and Radiological Health (CDRH)
{20}------------------------------------------------
SHFCW (6400 and 7400 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical Application | Mode of Operations | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler(PD) | Combined[4] | Color VelocityMapping (TVM) | HarmonicImaging (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) |
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
[I] Small Organs includes Breast, Thyroid and Testicles
|2] Cardiac is Adult and Pediaine
|3} Musculo Skelctal - Nerve Block
|4| Combined modes are:
|5| Compound Imaging (Mview)
|b| 31}/ 41)
،
|7| Includes contrast (CnTi) in Adult Cardiar for left ventralie operification and visualization of the left ventricular endocardial border
Previously cleared via k | | | 302
{21}------------------------------------------------
| Clinical Application | Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler(PDI) | Combined[4] | Color VelocityMapping (TVM) | HarmonicImaging (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) |
EC1123 (6400 s ystern)
Intended use: Diagnostic ultresound imaging or fluid flow analysis of human body as follows:
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
| } | Small Organs includes Breast, Thyrold and Teaticlea
|2| Cardiac is Adult and Pediatinc
|3| Musculo Skeletal - Nerve Block
|4} Combined modes ure: B+M+PW+CFM+PD
|5| Campound Imaging (Mview)
l6| 3D/4D
|7| Includes contrast (CnTi) in Adult Cardiac for left ventricle opacification and
Previously cleared via K110688
Prescription Use Only Per 21 CFR 801 Part D
{22}------------------------------------------------
SE3123 (6400 and 7400 systems)
| Clinical Application | Mode of Operations | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler(PD) | Combined[4] | Color VelocityMapping (TVM) | HarmonicImaging (TEI) | Other (specify) | ||||
| Ophthalmic | |||||||||||||
| Fetal | P | P | P | P | P | P | P. S | ||||||
| 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. S | |||||
| 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. S |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
N: New indication: P: Previously cleared by FDA; E:Added under Appenduz E
[ ] | Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
|3| Musculo Skeletal - Nerce Black
|4| Cambuned modes are: B+M+PW+CFM+PD
{5} Compound Imaging {Mvsew|
16| 3D/4D
|7| Includes contrast (CaTI) in Adult Cardiac for left ventracte opacification and visualization of the left ventricular endocardial border
.
Previously cleared via k 1 1 1302
{23}------------------------------------------------
TRT33 (6400 system)
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | P/W | CWD | ColorDoppler | AmplitudeDoppler(PD) | Combined(4) | Color VelocityMapping (TVM) | HarmonicImaging (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 | P | P | P | P | P | P | P | P. S | ||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional 3 | ||||||||||
| Musculo-skeletal Superficial 3 | ||||||||||
| Other (Urological) | P | P | P | P | P | P | P | P. S |
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
| | Small Organs includes Breast, Thyroid and Testicles
|2| Cardiac is Adult and Pediatric
|3| Musculo Skeletal - Nerve Block
|4| Combined modes are: B+M+PW+CFM+PD
|5| Compound Imaging (Mview)
le| JD/4D
|7} Includes contrast (CaTI) in Adult Cardiar for left ventry)e operification and visualization of the left ventricular endocardial border
Previously cleared via k1 | 1302
Prescription Use Only Per 21 CFR 801 Part D Concurrence of Center for Devices and Radiological Health (CDRH)
Page 18 of 23
{24}------------------------------------------------
ST2612 (6400 and 7400 systems)
.
| Mode of Operations | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler(PD) | Combined[4] | Color VelocityMapping (TVM) | HarmonicImaging (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 | P 5 | |
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional[3] | |||||||||||
| Musculo-skeletal Superficial [3] | |||||||||||
| Other (Urological) |
Intended use: Diagnostic utrasound imaging or fluid flow analysis of human body as follows:
N: New indication; P: Previously cleared by FDA; B:Added under Appendix E
| | Small Organs includes Breast, Thyroid and Testicles
|2| Cardiac is Adult and Pedialric
]3] Musculo Skeletaj • Nerve Block
|4} Combined modes are: B+M+PW+CW+CFM+PD
|5| Compound Imaging (Mview)
16| 3D/4D
|7| Includes contrast (CnTI) in Adult Cardiae for left ventricie opacification and visualization of the fell ventricular endocardial horder
Previously cleared via k1111302
{25}------------------------------------------------
BC441 (6400 system)
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler(PD) | Combined[4] | Color VelocityMapping (TVM) | HarmonicImaging (TEI) | Other (specify) |
| Ophthalmic | ||||||||||
| Fetal | N | N | N | N | N | N | N | N: 5, 6 | ||
| Abdominal | N | N | N | N | N | N | N | N: 5, 6 | ||
| 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) |
| 1 | Small Organs includes Breast, Thyroid and Testicles
|2] Cardiac in Adult and Pediatric |3} Musculo Skeletal - Nerve Block
|4} Combined modes are: B+M+PW+CFM+PD
H
(5) Compound Imaging (Mview)
מ/4D ₪/4D
{7} Includes contrast (Crill) in Adult Cardiac for left ventricte opecification and
.
To be cleared via this u braussion
{26}------------------------------------------------
BC431 (6400 system)
| Clinical Application | Mode of Operations | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler(PD) | Combined(4) | Color VelocityMapping (TVM) | HarmonicImaging (TEI) | Other (specify) | |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | P | P | P. 5, 6 | |
| Abdominal | P | P | P | P | P | P | P | P | P. 5, 6 | |
| 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) |
Intended use: Diagnostic ultrasound imaging or fitsid flow analysis of human body as follows:
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
[1] Small Organs includes Breast, Thyroid and Testicles
- Cardian is Adult and Pedistric
|3| Musculo Skeleta] - Nerve Block
|4) Combined modes are: B+M+PW+CFM+PD
(5) Compound Imaging (Mview)
l6} 3D/4D
[7] Includes contrast (CnTD in Adult Cardine for left ventnele opacification and
Previously cleared via k I 10688
{27}------------------------------------------------
BE1123 (6400 system)
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | P | P. 5, 6 | ||
| 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, 6 | ||
| Transvaginal | P | P | P | P | P | P | P | P. 5, 6 | ||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional [3] | ||||||||||
| Musculo-skeletal Superficial [3] | ||||||||||
| Other (Urological) |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
N: New indication, P: Previously cleared by FDA; E:Added under Appendix E
| | | Small Organs includes Breast, Thyroid and Teaticles
12| Cardiac is Adult and Pediatric
|3| Musculo Skeleiai • Nerve Black
|4| Combined modes are: B+M+PW+CFM+PD
|5) Compound Imaging (Mview)
|6| 3D/41>
|7) Includes contrast (CnTl) in Adult Cardine for left ventricle opecification and
Previously cleared via k | 10688
{28}------------------------------------------------
SB2C41 (6400 and 7400 systems)
| Clinical Application | Mode of Operations | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler(PD) | Combined[4] | Color VelocityMapping (TVM) | HarmonicImaging (TEI) | Other (specify) | |
| Ophthalmic | ||||||||||
| Fetal | N | N | N | N | N | N | N | N | N 5, 6 | |
| Abdominal | N | N | N | N | N | N | N | N | N 5, 6 | |
| 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) |
{ | | Small Organs includes Breast, Thyroud and Testicles
12| Cardiac is Adult and Pediatric
|3| Musculo Skeleta! - Nerve Block
|-1) Combined modes are: B+M+PW+CFM+PD
(5) Compound Imaging |Mview|
16] JD/4D
|7| Includes contrast (CnT) in Adult Cardiac for left ventricle operification and
To be cleared via this submission
Prescription Use Only Per 21 CFR 801 Part D Concurrence of Center for Devices and Radiological Health (CORH)
'
§ 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.