← Product Code [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN) · K091009
# MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150 (K091009)
_Esaote, S.p.A. · IYN · May 18, 2009 · Radiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K091009
## Device Facts
- **Applicant:** Esaote, S.p.A.
- **Product Code:** [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN.md)
- **Decision Date:** May 18, 2009
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1550
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Pediatric, 3rd-Party Reviewed
## Intended Use
Esaote's Model 7340 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 7340 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 6150 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6150 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
7340 (portable) and 6150 (mainframe) ultrasound systems perform diagnostic general ultrasound studies. Systems accept inputs from linear, convex, and phased array probes; process signals using modes including B-Mode, M-Mode, Doppler, Color Flow Mapping, Amplitude Doppler, Tissue Velocity Mapping, and Tissue Enhancement Imaging. New features include Elastography (ElaXto) analysis and 3D/4D modality for specific applications. Systems are operated by clinicians in clinical settings. Output is displayed on an LCD monitor to assist in diagnosis, biopsy guidance, and needle placement. Benefits include real-time imaging for anatomical assessment and procedural guidance.
## Clinical Evidence
Bench testing only. No clinical data provided. Substantial equivalence is supported by performance comparisons to predicate devices regarding elastography, 3D/4D imaging, and adherence to safety and acoustic output standards.
## Technological Characteristics
Ultrasound imaging systems (portable 7340, mainframe 6150). Supports linear, convex, phased array probes. Modes: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, TVM, TEI, CnTI. Features: Elastography (ElaXto), 3D/4D, XView, MView, TPView. Connectivity: LCD display. Safety: IEC60601-1, IEC60601-2-37. Acoustic output per AIUM/NEMA standards. Quality system: ISO 9001:2000, ISO 13485.
## Regulatory 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
- S2000 ([K072786](/device/K072786.md))
- Voluson E8 ([K061682](/device/K061682.md))
- 7340 ([K081794](/device/K081794.md))
- 6150 ([K051308](/device/K051308.md), [K052805](/device/K052805.md), [K060827](/device/K060827.md), [K081386](/device/K081386.md))
## Submission Summary (Full Text)
> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).
{0}------------------------------------------------
**510(k) Summary**
7340 & 6150 Systems
Esaote, S.p.A.
KC91009
Page 1 of 3
MAY 18 2009
# 510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 1807.92(a).
#### 807.92(a)(1)
### Submitter Information
Allison Scott The Anson Group 11460 N Meridian St., Ste 150 Carmel, Indiana 46032 Phone: (317) 569-9500 x106 Facsimile: (317) 569-9520 Ascott@ansongroup.com
| Contact Person: | Allison Scott |
|-----------------|---------------|
|-----------------|---------------|
Date: March 5, 2009
807.92(a)(2)
Trade Name: 7340 & 6150 Systems
Common Name: Ultrasound Imaging System
Ultrasonic pulse Doppler imaging system 892.1550 Classification Name(s): Ultrasonic pulsed echo imaging system 892.1560
Classification Number: 90IYN; 90IYO
#### 807.92(a)(3)
### Predicate Device(s)
K051308, K052805, K060827, and K081386 K081794 K072786 K061682
(150 7340 S2000 Voluson E8
Esaote, S.p.A. Siemens General Electric
Esaote, S.p.A.
{1}------------------------------------------------
KC91009
Page 2 of 3
510(k) Summary 7340 & 6150 Systems Esaote, S.p.A.
807.92 (a)(4)
### Device Description
The 7340 and 6150 system designs remain the same as those previously cleared by FDA via K081794, K051308, K052805, K060827, and K081386, respectively, except for those features being added via this submission.
The 6150 is a mainframe ultrasound system, and the 7340 is a portable ultrasound system, both are used to perform diagnostic general ultrasound studies. Their primary modes of operation are: B-Mode, M-Mode, XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The systems are equipped with a LCD Color Display and are capable of operating Linear, Convex, and Phased array probes.
The 7340 and 6150 systems are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.
807.92(a)(5)
#### Intended Use(s)
Esaote's Model 7340 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 7340 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 6150 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6150 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}------------------------------------------------
K09mc9
Page 3 of 3
510(k) Summary 7340 & 6150 Systems Esaote, S.p.A.
#### 807.92(a)(6)
### Technological Characteristics
The 7340 model has been cleared via K081794; the 6150 has been cleared via K051308, K052805, K060827 and K081386.
The Elastography (ElaXto) analysis is substantially equivalent to Siemens eSie Elasticity Imaging module available with S2000 system cleared via K072786.
The 3D/4D modality in Transvaginal, Transrectal and Urology applications is substantially equivalent to 3D/4D modality in the same applications available with RIC5-9-D probe of General Electric Voluson E8 system cleared via K061682.
- · Clinical uses for which the 7340 and 6150 are designed, to be added with this submission, are equivalent to those of the Siemens S2000 ultrasound system, cleared via K072786 and by the General Electric Voluson E8 cleared via K061682.
- · The 7340, 6150 and Siemens S2000 ultrasound systems are able to provide Elastographic analysis on real-time images, by applying low compression and retraction movements on the patient using the probe to evaluate the modification of the echo signal.
- · The 7340, 6150 and General Electric Voluson E8 systems are able to provide the 3D/4D modality in Transvaginal, Transrectal and Urology applications by simultaneously controlling two independent scan planes for volumetric acquisition.
- · 7340, 6150, Siemens S2000 and General Electric Voluson E8 are designed to meet the IEC60601-1 and IEC60601-2-37 safety requirements.
- · 7340, 6150, Siemens S2000 and General Electric Voluson E8 provide an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping lines or ribbons, creating a sense of movement or flow.
Public Health Service
MAY 18 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Esaote, S.p.A. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K091009
Trade/Device Name: 7340 Ultrasound Systems and 6150 Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 4, 2009 Received: May 5, 2009
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the 7340 Ultrasound Systems and 6150 Ultrasound Systems, as described in your premarket notification:
#### Transducer Model Number
#### Model 7340
| PA230 | PA122 | LA424 |
|-------|-------|-------|
| PA240 | PA023 | LA435 |
| PA121 | LA332 | LA522 |
{4}------------------------------------------------
Page 2 - Mr. Job
| LA523
LA532
C5-2
CA123
CA421
CA1421
CA430
CA431 | CA621
CA631
2 CW
5 CW
E8-5
EC123
EC1123
TRT33 | TEE022
TEE122
IOE323
LP323
BC431
BE1123 |
|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| PA230
PA240
PA121
PA122
PA023
LA332
LA522
LA523
LA532
LA424
LA435 | LA923
C5-2
CA123
CA421
CA621
CA430
CA431
CA631
2CW
5CW
EC123 | EC1123
TEE022
TEE132
IOE323
LP323
BC431
BL433
BE1123
TRT33 |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small
tone?
{5}------------------------------------------------
Page 2 — Mr. Job
Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Lauren Hefner at (240) 276-3666.
Sincerely yours,
Helent Lenn
for Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health .
#### Enclosure(s)
、 :
{6}------------------------------------------------
Indications for Use Statement
### Models 7340 and 6150
### Indications for Use
510(k) Number (if known):
K091009
Device Name:
7340 Ultrasound Systems 6150 Ultrasound Systems
Esaote's Model 7340 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 7340 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 6150 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6150 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 X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH/Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K091009
{7}------------------------------------------------
## Mod.7340
### Intended use:
Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:
| | Mode of Operations | | | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|-----|---------------------------------------|------|------------------------------------|
| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
[3] | TVM | Tissue
Enhacement
Imaging (TEI) | CnTI | Other (specify) |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | P | | P: 5, 6, 7, 8, 9, 10 |
| Abdominal | P | P | P | P | P | P | P | | P | E | P: 4, 5, 6, 7, 8, 9, 13 |
| Intraoperative (Abdominal) | P | P | P | P | P | P | P | | P | | P: 4, 5, 6, 8, 9, 13 |
| Intraoperative Neurological | P | P | P | | P | P | P | | P | | |
| Pediatric | P | P | P | P | P | P | P | | P | | P: 4, 5, 6, 8, 9, 13 |
| Small Organ [1] | P | P | P | | P | P | P | | P | E | P: 4, 5, 6, 8, 9, 13;
N: 14 |
| Neonatal Cephalic | P | P | P | P | P | P | P | | P | | P: 5, 6, 8, 9 |
| Adult Cephalic | P | P | P | P | P | P | P | | P | | P: 6, 8, 9 |
| Cardiac [2] | P | P | P | P | P | P | P | P | P | E | P: 4, 6, 7, 8, 9, 11,
12 |
| Transesophageal (Cardiac) | P | P | P | P | P | P | P | P | P | | P: 4, 6, 9, 11, 12 |
| Transesophageal (Non Cardiac) | P | P | P | | P | P | P | | P | | |
| Transrectal | P | P | P | | P | P | P | | P | | P: 4, 5, 6, 8, 9, 13;
N: 14 |
| Transvaginal | P | P | P | | P | P | P | | P | | P: 5, 6, 8, 9 |
| Transurethral | P | P | P | | P | P | P | | P | | |
| Intravascular | P | P | P | | P | P | P | | P | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | E | P: 4, 5, 6, 7, 8, 9,
10, 12, 13 |
| Laparoscopic | P | P | P | | P | P | P | | P | | P: 4, 5, 6, 8, 9, 13 |
| Musculo-skeletal Conventional
(including Nerve Blocking) | P | P | P | | P | P | P | | P | | P: 4, 5, 6, 8, 9, 13;
N: 14 |
| Musculo-skeletal Superficial
(including Nerve Blocking) | P | P | P | | P | P | P | | P | | P: 4, 5, 6, 8, 9, 13;
N: 14 |
| Other (Urological) | P | P | P | | P | P | P | | P | | P: 4, 5, 6, 8, 9, 13 |
[4]
(5) (છ)
[7]
(8)
lal
CMM
MView
3D
4D
VPan
XView
QIMT
.
(10)
[1] Stress [12] Strain
(13) TP View
[14] ElaXto
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiologicat Devices
510(k) Number K091009
{8}------------------------------------------------
Intended use:
Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:
| Clinical Application | Mode of Operations | | | | | | | | | | |
|----------------------------------------------------------|--------------------|---|-----|-----|---------------|-------------------|--------------|-----|---------------------------------|------|-----------------------|
| | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [3] | TVM | Tissue Enhacement Imaging (TEI) | CnTI | Other (specify) |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | | P | E | P: 6, 8, 9 |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ [1] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | | P | | P: 6, 8, 9 |
| Cardiac [2] | P | P | P | P | P | P | P | P | P | E | P: 4, 6, 8, 9, 11, 12 |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional (including Nerve Blocking) | | | | | | | | | | | |
| Musculo-skeletal Superficial (including Nerve Blocking) | | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | | |
N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E
(Previously cleared: k081794 )
[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
Cardiac is Adult and Pediatric
CMM
3D
- (2) [3]
- (4)
- (6)
- [8] VPan
- XView (a)
- (11) Stress
- (12) Strain
Combined modes are: B + M + PW + CW + CFM + PD
CMM
3D
VPan
XView
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{9}------------------------------------------------
Intended use:
Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:
| | Mode of Operations | | | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|---------|---------|------------------|----------------------|-----------------|-----|----------------------------------------|------|--------------------|
| Clinical Application | B | M | PW
D | CW
D | Color
Doppler | Amplitude
Doppler | Combined
[3] | TVM | Tissue
Enhancement
Imaging (TEI) | CnTI | Other (specify) |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | E | E | E | E | E | E | E | | E | | P: 8, 9 |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ [1] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | E | E | E | E | E | E | E | | E | | P: 8, 9 |
| Cardiac [2] | E | E | E | E | E | E | E | E | E | | P: 4, 8, 9, 11, 12 |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional
(including Nerve Blocking) | | | | | | | | | | | |
| Musculo-skeletal Superficial
(including Nerve Blocking) | | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | | |
N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|------|-----------------------------------------------------|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CW + CFM + PD |
| [4] | CMM |
| [8] | VPan |
| [9] | XView |
| [11] | Stress |
| [12] | Strain |
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{10}------------------------------------------------
Intended use:
Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:
| | Mode of Operations | | | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|-----|---------------------------------------|------|--------------------|
| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
[3] | TVM | Tissue
Enhacement
Imaging (TEI) | CnTI | Other (specify) |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | E | E | E | E | E | E | E | | E | | P: 8, 9 |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ [1] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | E | E | E | E | E | E | E | | E | | P: 4, 8, 9, 11, 12 |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional
(including Nerve Blocking) | | | | | | | | | | | |
| Musculo-skeletal Superficial
(including Nerve Blocking) | | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | | |
N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|------|-----------------------------------------------------|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CW + CFM + PD |
| [4] | CMM |
| [8] | VPan |
| [9] | XView |
| [11] | Stress |
| [12] | Strain |
.k.leum
. .
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K091009
{11}------------------------------------------------
Intended use:
Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:
| Clinical Application | Mode of Operations | | | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|-----|---------------------------------------|------|--------------------------|
| | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
[3] | TVM | Tissue
Enhacement
Imaging (TEI) | CnTI | Other (specify) |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P | | P: 6, 8, 9 |
| Small Organ [1] | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | | P | | P: 6, 8, 9 |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | P | P | P | P | P | P | P | P | P | | P: 4, 6, 8, 9, 11,
12 |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | | P: 6, 8, 9, 12 |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional
(including Nerve Blocking) | | | | | | | | | | | |
| Musculo-skeletal Superficial
(including Nerve Blocking) | | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | | |
N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E
(Previously cleared: k081794)
[1] Small Organ includes Breast, Thyroid and Testicles
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|------|-----------------------------------------------------|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CW + CFM + PD |
| [4] | CMM |
| [6] | 3D |
| [8] | VPan |
| [9] | XView |
| [11] | Stress |
| [12] | Strain |
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K091009
{12}------------------------------------------------
Intended use:
Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:
| | Mode of Operations | | | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|-----|----------------------------------------|------|--------------------|
| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
[3] | TVM | Tissue
Enhancement
Imaging (TEI) | CnTI | Other (specify) |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | E | E | E | E | E | E | E | | | CnTI | P: 8, 9 |
| Small Organ [1] | | | | | | | | | | | |
| Neonatal Cephalic | E | E | E | E | E | E | E | | | | P: 8, 9 |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | E | E | E | E | E | E | E | | | | P: 4, 8, 9, 11, 12 |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | E | E | E | E | E | E | E | | | | P: 8, 9 |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional
(including Nerve Blocking) | | | | | | | | | | | |
| Musculo-skeletal Superficial
(including Nerve Blocking) | | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | | |
N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|------|-----------------------------------------------------|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CW + CFM + PD |
| [4] | CMM |
| [8] | VPan |
| [9] | XView |
| [11] | Stress |
| [12] | Strain |
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number
{13}------------------------------------------------
### Intended use:
Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:
| | Mode of Operations | | | | | | | | | | |
|--------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|-----|----------------------------------------|------|---------------------------------|
| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
[3] | TVM | Tissue
Enhancement
Imaging (TEI) | CnTI | Other (specify) |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | | P: 4, 5, 6, 8, 9, 13 |
| Small Organ [1] | P | P | P | | P | P | P | | P | | P: 4, 5, 6, 8, 9, 13;
N:14 |
| 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: 4, 5, 6, 8, 9, 10,
12, 13 |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional
(including Nerve Blocking) | P | P | P | | P | P | P | | P | | P: 4, 5, 6, 8, 9, 13;
N: 14 |
| Musculo-skeletal Superficial .
(including Nerve Blocking) | P | P | P | | P | P | P | | P | | P: 4, 5, 6, 8, 9, 13;
N: 14 |
| Other (Urological) | | | | | | | | | | | |
N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E (Previously cleared: k081794 }
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|------|-----------------------------------------------------|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CFM + PD |
| [4] | CMM |
| [5] | MView |
| [6] | 3D |
| [8] | VPan |
| [9] | XView |
| [10] | QIMT |
| [12] | Strain |
| [13] | TP View |
| [14] | ElaXto |
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
| 510(k) Number | K091009 |
|---------------|---------|
|---------------|---------|
{14}------------------------------------------------
### Intended use:
Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:
| | Mode of Operations | | | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|-----|---------------------------------------|------|-----------------------------|
| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
[3] | TVM | Tissue
Enhacement
Imaging (TEI) | CnTI | Other (specify) |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | E | E | E | | E | E | E | | | | P: 4, 5, 6, 8, 9, 12 |
| Small Organ [1] | E | E | E | | E | E | E | | | | P: 4, 5, 6, 8, 9, 12 |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | E | E | E | | E | E | E | | | | P: 4, 5, 6, 8, 9,
12. 13 |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional
(including Nerve Blocking) | E | E | E | | E | E | E | | | | P: 4, 5, 6, 8, 9, 12 |
| Musculo-skeletal Superficial
(including Nerve Blocking) | E | E | E | | E | E | E | | | | P: 4, 5, 6, 8, 9, 12 |
| Other (Urological) | | | | | | | | | | | |
N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|------|-----------------------------------------------------|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CFM + PD |
| [4] | CMM |
| [5] | MView |
| [6] | 3D |
| [8] | VPan |
| [9] | XView |
| [12] | Strain |
| [13] | TP View |
・
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{15}------------------------------------------------
Intended use:
Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:
| | Mode of Operations | | | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|-----|---------------------------------------|------|--------------------------------|
| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
[3] | TVM | Tissue
Enhacement
Imaging (TEI) | CnTI | Other (specify) |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | E | E | E | E | E | E | E | | | | P: 4, 5, 6, 8, 9, 13 |
| Small Organ [1] | E | E | E | E | E | E | E | | | | P: 4, 5, 6, 8, 9,
13: N: 14 |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | E | E | E | E | E | E | E | | | | P: 4, 5, 6, 8, 9,
12. 13 |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional
(including Nerve Blocking) | E | E | E | E | E | E | E | | | | P: 4, 5, 6, 8, 9,
13; N: 14 |
| Musculo-skeletal Superficial
(including Nerve Blocking) | E | E | E | E | E | E | E | | | | P: 4, 5, 6, 8, 9,
13; N: 14 |
| Other (Urological) | | | | | | | | | | | |
N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|------|-----------------------------------------------------|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CFM + PD |
| [4] | CMM |
| [5] | MView |
| [6] | 3D |
| [8] | VPan |
| [9] | XView |
| [12] | Strain |
| [13] | TP View |
| [14] | ElaXto |
(Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{16}------------------------------------------------
Intended use:
Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:
| | Mode of Operations | | | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|-----|---------------------------------------|------|---------------------------------|
| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
[3] | TVM | Tissue
Enhacement
Imaging (TEI) | CnTI | Other (specify) |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | E | E | E | | E | E | E | | E | | P: 4, 5, 6, 8, 9, 12 |
| Small Organ [1] | E | E | E | | E | E | E | | E | | P: 4, 5, 6, 8, 9,
13: N: 14 |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | E | E | E | | E | E | E | | E | | P: 4, 5, 6, 8, 9,
10, 12, 13 |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional
(including Nerve Blocking) | | | | | | | | | | | |
| Musculo-skeletal Superficial
(including Nerve Blocking) | | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | | |
N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|------|-----------------------------------------------------|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CFM + PD |
| [4] | CMM |
| [5] | MView |
| [6] | 3D |
| [8] | VPan |
| [9] | XView |
| [10] | QIMT |
| [12] | Strain |
| [13] | TP View |
| [14] | ElaXto |
(Division Sign-Off)
Division of Reproductive, Abdominal andRadiological Devices 510(k) Number
:
{17}------------------------------------------------
Intended use:
Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:
| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
[3] | TVM | Tissue
Enhancement
Imaging (TEI) | CnTI | Other (specify) |
|-------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------|-----|----------------------------------------|------|---------------------------------|
| Ophthalmic | | | | | |…
---
**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K091009](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K091009)
**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).
**Cite:** Innolitics at https://innolitics.com