MYLABSSOGNO
Device Facts
| Record ID | K140677 |
|---|---|
| Device Name | MYLABSSOGNO |
| Applicant | Esaote, S.p.A. |
| Product Code | IYN · Radiology |
| Decision Date | Apr 25, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
Esaote's Model 7348 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative abdomninal, Laparoscopic and Other: Urologic. The 7348 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
Device Story
Portable ultrasound system (Model 7348) with handle and battery power; utilizes phased, convex, linear array, and Doppler probes. Operates in B-Mode, TEI, MView, CW/PW Doppler, CFM, and Amplitude Doppler. Upgrade adds Tissue Velocity Mapping (TVM), Compass M-Mode (free positioning), Stress Echo (wall motion abnormality detection via 2D loop comparison), and real-time Intima Media Thickness (IMT) measurement. Used in clinical settings by healthcare professionals for diagnostic imaging and interventional guidance. Output displayed on LCD; assists clinicians in diagnosis and procedural placement of needles/catheters. Benefits include portable diagnostic capability and automated measurement tools for vascular and cardiac assessment.
Clinical Evidence
No clinical tests were performed. Substantial equivalence is supported by non-clinical bench testing, including acoustic output measurement, biocompatibility, thermal/electromagnetic/mechanical safety, and conformance to IEC and NEMA standards.
Technological Characteristics
Portable ultrasound system with LCD display; supports phased, convex, linear, and Doppler probes. Powered by battery. Software features include TVM, Compass M-Mode, Stress Echo, and automated IMT measurement. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD-2, and NEMA UD-3. Manufactured under ISO 9001:2000 and ISO 13485 quality systems.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in patients requiring cardiac, vascular, abdominal, fetal, small organ, musculoskeletal, neonatal/adult cephalic, transesophageal, transrectal, transvaginal, pediatric, intraoperative, laparoscopic, or urologic examinations. Includes needle guidance for biopsy, vascular access, and peripheral nerve blocks.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
Submission Summary (Full Text)
{0}------------------------------------------------
## APR 2 5 2014
K140677
Page 1 of 3
# 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 317.228.8719 allison.scott@navigant.com
Date:
#### March 17, 2014
807.92(a)(2)
## Devices
| Common Name: | Ultrasound Imaging System |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | 7348 Ultrasound System |
| Classification Name(s): | Ultrasound Pulse Doppler Imaging System 892.1550<br>Ultrasound Pulse Echo Imaging System 892.1560<br>Transducer, Ultrasonic, Diagnostic 892.1570 |
| Classification Number: | 90IYN, 90IYO, 90ITX |
807.92(a)(3)
. ·
-
### Predicate Device(s)
| Device | Owner | 510(k) |
|--------|--------|-------------------|
| 7348 | Esaote | K121384 |
| 7340 | Esaote | K081794, K091009, |
| | | K110688 |
{1}------------------------------------------------
#### 807.92(a){4)
### Device Description
Model 7348 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, Tissue Enhancement Imaging (TEI), Multi View (MView), CW and PW Doppler, Color Flow Mapping (CFM) and Amplitude Doppler (AD). 7348 is equipped with a LCD color display where acquired images and advanced image features are shown. 7348 can drive Phased, Convex, Linear array and Doppler probes. Model 7348 has been designed to be powered by battery.
7348 has been previously cleared via k121384.
7348 Upgrade, defined herein, combine the cleared features of 7348 system with new software capabilities, listed below:
- Managing of Tissue Velocity Mapping (TVM) and Tissue Velocity (TV) mode. 1.
- 2. Managing of M-Mode with free positioning of the acquisition line (Compass M-Mode).
- Management of Stress Echo where detection of the occurrence of stress-induced wall motion 3. abnormalities is derived through comparison of 2D loops, displaying wall motion at rest and during and after stress.
- Management of Intima Media Thickness to automatically measure the thickness between the 4. intima and the media on the image in real time.
The 7348 Upgrade is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.
807.92(a)(5)
## Intended Use
Esaote's Model 7348 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative abdomninal, Laparoscopic and Other: Urologic. The 7348 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
The 7348 Upgrade employs the same fundamental technological characteristics as their predicate devices. The 7348 Upgrade model is substantially equivalent to Esaote 7348 model cleared via K121384, and to Esaote 7340 model cleared by FDA via K081794, K091009, K110688.
- · Clinical uses for which Esaote 7348 model, cleared by FDA via K121384, are designed are not changed by 7348 Upgrade, to be cleared via this submission.
{2}------------------------------------------------
K140677
page 3 of 3
- · Clinical uses for which Esaote 7348 Upgrade is designed are equivalent to those of Esaote 7348 model cleared via K121384, and to Esaote 7340 model cleared by FDA via K081794, K091009, K110688.
- 7348 upgrade for managing Tissue Velocity Mapping (TVM) and Tissue Velocity (TV) mode is equivalent to Esaote 7340 model cleared by FDA via K081794, K091009, K110688.
- · 7348 upgrade for managing M-Mode with free positioning of the acquisition line (Compass M-Mode) is equivalent to Esaote 7340 model cleared by FDA via K081794, K091009, K110688.
- · 7348 upgrade for managing Stress Echo, where detection of the occurrence of stress-induced wall motion abnormalities is derived through comparison of 2D loops, displaying wall motion at rest and during or after stress, is equivalent to Esaote 7340 model cleared by FDA via K081794, K091009, K110688.
- · 7348 upgrade for managing Intima Media Thickness to automatically measure the thickness between the intima and the media on the image in real time , is equivalent to Esaote 7340 model cleared by FDA via K081794, K091009, K110688.
- Esaote 7348 Upgrade, 7348 and 7340 ultrasound models are designed to meet the IEC60601-1 and IEC60601-2-37 safety requirements.
- · Esaote 7348 Upgrade, 7348 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 .
- IEC 6060 1-2-37 ●
- NEMA UD-3 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices . on Diagnostic Ultrasound Equipment
- NEMA UD-2 Acoustic Output Measurement Standard for Diagnostic Ultrasound .
807.92(b)(2)
### Summary of Clinical Tests
No clinical tests were performed.
807.92(b)(3)
#### Conclusion
The 7348 Upgrade is substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.
{3}------------------------------------------------
#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 25, 2014
Esaote S.P.A. % Allison Scott Senior Consultant 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268
Re: K140677 Trade/Device Name: 7348/MyLabSogno Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed Doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 17. 2014 Received: March 18. 2014
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. Ilisting 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 MylabSogno, as described in your premarket notification:
| Transducer Model Number | | |
|-------------------------|--------|--------|
| PA230 | CA123 | IOE323 |
| PA122 | CA431 | LP323 |
| PA023 | 2 CW | TEE132 |
| LA435 | 5 CW | TEE022 |
| LA522 | HFCW | |
| LA523 | EC1123 | |
{4}------------------------------------------------
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 Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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/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.goy/MedicalDevices/ResourcesforYou/Industry/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
{5}------------------------------------------------
#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
#### 510(k) Number (if known) K140677
Device Name 7348/MyLabSogno
#### Indications for Use (Describe)
Estole's Model 7.48 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophaged Cardiac, Peripheral Vascular, Neonalic, Adult Ceplalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Feal, Transresal, Pediatic, Intraoperative abdominal, Laparoscopic and Other: Urologic, The 7.48 system provides innaging 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)
[ሬ] Prescription Use (Parl 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
## Please do not write below this line – continue on a separate page if needed.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sm)
FORM FBSaBBoRD(1784) Upgrade 510(k)
Page Baladin 1932 " " " 11 -a" w
{6}------------------------------------------------
### 7348 Upgrade
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical Application | Mode of Operations | | | | | | | | | | Other (specify) |
|-------------------------------------------------------------|--------------------|---|-----|-----|---------------|-------------------|--------------|-------------------------------|------------------------|--|-----------------|
| | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [3] | Tissue Velocity Mapping (TVM) | Harmonic Imaging (TEI) | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | P | | |
| Abdominal | P | P | P | P | P | P | P | | P | | |
| Intraoperative (Abdominal) | P | P | P | | P | P | P | | P | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P | | |
| Small Organ [1] | P | P | P | | P | P | P | | P | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | | P | | |
| Adult Cephalic | P | P | P | P | P | P | P | | P | | |
| Cardiac [2] | P | P | P | P | P | P | P | N | P | | |
| Transesophageal (Cardiac) | P | P | P | P | P | P | P | N | P | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | P | P | P | | P | P | P | | P | | |
| Transvaginal | P | P | P | | P | P | P | | P | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | | |
| Laparoscopic | P | P | P | | P | P | P | | P | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | P | P | P | | P | P | P | | P | | |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | P | P | P | | P | P | P | | P | | |
| Other (Urological) | P | P | P | | P | P | P | | P | | |
.
:
N: New indication; I': Previosuly cleared by FDA; E:Added under Appendix E
Small Organs includes Breant, Thyroid and Testicles 비 시 Cardiac is Adult and Pediatric Combined modes arc: B + M + PW + CW + CFM + I'D
.
Previously cleared via k 121384
|3|
Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH
・
.
{7}------------------------------------------------
7348 - PA230
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | Tissue<br>Velocity<br>Mapping<br>(TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
|-------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------|----------------------------------------|---------------------------|-----------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | | P | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | | P | |
| Cardiac [2] | P | P | P | P | P | P | P | N | P | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional (including<br>Nerve Blocking) | | | | | | | | | | |
| Musculo-skeletal Superficial (including<br>Nerve Blocking) | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |
Intended use: Diagnostic ullrasound imaging or fluid flow analysis of human body as follows:
N: New indication: P: Previosuly cleared by FDA: E:Added under Appendix E
.
-
Previously cleared van k121384
וי ו 121 (3)
Small Organs includes Breast. Theroid und Testicles Cardiac in Adult and Pedialric Combined modes are: B + M + PW • CW + CFM + PD
> Prescription Use Only Per 21 CFR 801 Parl D Concumence of CDRH
> > .
. 1
·
·
{8}------------------------------------------------
#### 7348 - PA122
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | Tissue<br>Velocity<br>Mapping<br>(TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | |
|-------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------|----------------------------------------|---------------------------|-----------------|--|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | | | |
| Small Organ [1] | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | P | P | P | P | P | P | P | N | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | | | | | | | | | | | |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
FOR YOUR HEALTH AND WELL-BEING
Previously cleared via k121384
ויין |김 Small Organs includes Breast. Theroid and Testicles
Cardiac is Adult and Fetal.
.
리가
·
Cardiac is Adult and Pediatric
Combined modes are: H + M + PW + CW + CliM • 14)
.
.
Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH
.
.
{9}------------------------------------------------
#### 7348 - PA023
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical Application | H | M | IWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | Tissue<br>Velocity<br>Mapping<br>(TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
|-------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------|----------------------------------------|---------------------------|-----------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | | |
| Small Organ [1] | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | P | P | P | P | P | P | P | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | | | | | | | | | | |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via k l 2 1 384
ויין 기
131
:
Small Organs includes Breast, Thyoid and Testicles Cariliar in Adult and Pediatric
:
Combined modes are: B + M + PW + CW • CFM • PD
Prescription Use Only Per 21 CFR 801 Parl D Concurrence of CDRH
{10}------------------------------------------------
#### 7348 - LA435
:
| Clinical Application | Mode of Operations | | | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|----------------------------------------|---------------------------|----------------|--|
| | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | Tissue<br>Velocity<br>Mapping<br>(TVM) | Harmonic<br>Imaging (TEI) | Other (specify | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | | | |
| Small Organ [1] | P | P | P | | P | P | P | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | P | P | P | | P | P | P | | | | |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | P | P | P | | P | P | P | | | | |
| Other (Urological) | | | | | | | | | | | |
R. verify alerted via 8/12/2021
Previously cleared via k132231
Small Organs includes Breast, Theroid and Testicies ווין Cardiac is Adult and Pediatric 12| Combined modes nre: B + M • I'W • CFM • I'W 기
> Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH
> > ·
{11}------------------------------------------------
#### 7348 - LA522
| Clinical Application | Mode of Operations | | | | | | | | | Other (specify) |
|-------------------------------------------------------------|--------------------|---|-----|-----|---------------|-------------------|--------------|-------------------------------|------------------------|-----------------|
| | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [3] | Tissue Velocity Mapping (TVM) | Harmonic Imaging (TEI) | |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | |
| Small Organ [1] | P | P | P | | P | P | P | | P | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | | | | | | | | | | |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |
N: New indication: P Previosuly cleared by FDA: E:Added under Appendux E
.
Previously cleared via k L2 L384
ររ Small Organs meludes Breast, Thyroid and Testicles (2) Cardus is Adult and Priliatio 1가 Combined modes are: H + M • PW • CI·M • PI>
> Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH
> > ・
:
.
·
·
{12}------------------------------------------------
7348 - LA523
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [3] | Tissue Velocity Mapping | Harmonic Imaging (TEI) | Other (specify) |
|----------------------------------------------------------|---|---|-----|-----|---------------|-------------------|--------------|-------------------------|------------------------|-----------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | |
| Small Organ [1] | P | P | P | | P | P | P | | P | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional (including Nerve Blocking) | P | P | P | | P | P | P | | P | |
| Musculo-skeletal Superficial (including Nerve Blocking) | P | P | P | | P | P | P | | P | |
| Other (Urological) | | | | | | | | | | |
N: New indication; I': Previosulv cleared by FDA; E:Added under Appendux F
Previously cleared vin k132466
시
1-31
Small Organs meludes Breast, Theroid and Testicles ויין
:
.
Cardiac is Adult and Pedialrir
Combined modes are: B・M・TW ・ CFM ・ F1)
Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH
Esaale SpA 7348 Upgrade 510(k)
{13}------------------------------------------------
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | | | | | |
|----------------------------------------------------------------------------------------------|---|---|-----|-----|---------------|-------------------|--------------|-------------------------------|------------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [3] | Tissue Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | |
| Small Organ [1] | P | P | P | | P | P | P | | P | |
| Neonatal Cephalir | P | P | P | | P | P | P | | P | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | P | P | P | | P | P | P | | P | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional (including Nerve Blocking) | P | P | P | | P | P | P | | P | |
| Musculo-skeletal Superficial (including Nerve Blocking) | P | P | P | | P | P | P | | P | |
| Other (Urological) | | | | | | | | | | |
:
7348 - CA123
Intended use: Diagostic ultrasound imaging or fluid flo alvsis of hr n body as follows
N: New Indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via k121384
|| ||
Small Organs includes Breast. Thyroid and Testicles 111
(2) Cardiac is Adult and Pediatre
Combined modes arc: B + M + TW + CFM + FD
.
Prescription Use Only Per 21 CFR 801 Pan D Concurrence of CDRH
·
. . . . . .
:
:
·
{14}------------------------------------------------
7348 - CA431
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:<br>Clinical Application | Mode of Operations | | | | | | | | | |
|----------------------------------------------------------------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|----------------------------------------|---------------------------|-----------------|
| | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | Tissue<br>Velocity<br>Mapping<br>(TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | P | |
| Abdominal | P | P | P | | P | P | P | | P | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | |
| Small Organ [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 | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | P | P | P | | P | P | P | | P | |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | P | P | P | | P | P | P | | P | |
| Other (Urological) | P | P | P | | P | P | P | | P | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
N: New indication: P: Previosuly viened by FDA; 1:Added under Appendix E
:
.
Previously cleared via k121384
(リ) |가 |과 Small Organs includes Breast, Thyroxl and Tosticles Cardiac is Adult and Pediatric Combined modes are: 13 + M + PW + CFM + IPD
:
Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH
.
.
·
{15}------------------------------------------------
#### 7348 - 2 CW
| Clinical Application | Mode of Operations | | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|----------------------------------------|---------------------------|-----------------|
| | B | M | FWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | Tissue<br>Velocity<br>Mapping<br>(TVM) | Harmonic<br>Imaging (TEI) | Other [specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | P | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | | | | | | | | | | |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
:
·
Previously cleared via k l 21,384
미
(2)
Small Organs includes Breast, Thysoid and Testicles
.
Cardiac is Adult and Pediatric
Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH ・
.
Esacte SpA 7348 Upgrada 510(k)
.
{16}------------------------------------------------
| 7348 - 5 CW | Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | | | | |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------|---|-----|-----|------------------|----------------------|-----------------|----------------------------------------|---------------------------|-----------------|
| Clinical Application | Mode of Operations | | | | | | | | | Other (specify) |
| | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | Tissue<br>Velocity<br>Mapping<br>(TVM) | Harmonic<br>Imaging (TEI) | |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac (2) | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | |…
