MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)

K081386 · Esaote, S.p.A. · IYN · Sep 25, 2008 · Radiology

Device Facts

• Record ID: K081386
• Device Name: MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)
• Applicant: Esaote, S.p.A.
• Product Code: IYN · Radiology
• Decision Date: Sep 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Esaote's Model 6150 (MyLab70) and Model 6100 (MyLab90) are mainframe ultrasound systems used to perform diagnostic general ultrasound studies including Cardine unc Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative: Abdominal, and Other: Urologic. Additionally, the MyLab90 is indicated for Laparoscopic use. The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasond session. The second modality provides additional security in assessing the morphalogy of the ultrasound image. Virtual Navigator can be used in the following application: Abdominal, Musculo-skeletal, Urologic, and Vascular. The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congreent with the current (actual) patient position and shall therefore always been as an additional source of information. The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

Device Story

MyLab70 and MyLab90 are compact ultrasound systems for diagnostic imaging. They acquire B-mode, M-mode, Doppler, and Color Flow Mapping signals via phased, convex, and linear array probes. The systems produce real-time 2D and manual 3D images. An optional 'Virtual Navigator' license integrates external CT or MR image data during ultrasound sessions to assist in assessing morphology. The tracking system uses electromagnetic sensors (Ascension) to register the ultrasound probe with the second modality. The device is used in clinical settings by physicians or trained technicians. The output is displayed on an optional LCD monitor; clinicians use the fused ultrasound and secondary modality images to guide procedures or improve diagnostic confidence. The secondary modality image is not for standalone diagnosis. The system is manufactured under ISO 9001:2000 and ISO 13485 standards.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Mainframe ultrasound system; phased, convex, and linear array probes; electromagnetic tracking (Ascension); LCD color display; ISO 9001:2000/ISO 13485 certified manufacturing. Connectivity includes optional license for image fusion (Virtual Navigator).

Indications for Use

Indicated for diagnostic general ultrasound studies including cardiac, transesophageal, peripheral vascular, neonatal/adult cephalic, small organ, musculoskeletal, abdominal, fetal, transvaginal, transrectal, pediatric, intraoperative, and urologic applications. MyLab90 also indicated for laparoscopic use. Virtual Navigator indicated for abdominal, musculoskeletal, urologic, and vascular applications. Contraindicated for use on or around persons with cardiac pacemakers or life-supporting equipment.

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

• BrainLab IGSonic (K070106, K062086, K042391, K012564, K042512)
• Esaote MyLab70 (K051308)
• Esaote MyLab90 (K051837)
• Esaote MyLab 70, 90 (K060827)
• Hitachi RVS (K013722)

Submission Summary (Full Text)

{0}------------------------------------------------

K081386

510(k) Summary MyLab70, 90 Systems Esaote. S.p.A.

SEP 2 5 2008

### 510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).

807.92(a)(1)

### Submitter Information

Allison Scott The Anson Group 11460 N Meridian St., Ste 150 Carnel, Indiana 46032 Phone: [phone] x106 Facsimile: [phone] Ascott(a)ansongroup.com

Contact Person: Allison Scott

Date: August 12, 2008

807.92(a)(2)

Trade Name: MyLab70 & MyLab90 Systems

Common Name: Ultrasound Imaging System

Classification Name(s): Ultrasonic pulse doppler imaging system 892.1550 Ultrasonic pulsed echo imaging system 892.1560

Classification Number: 90IYN; 90IYO

807.92(a)(3)

### Predicate Device(s)

| K070106, K062086,<br>K042391, K012564, and<br>K042512 | BrainLab | IGSonic |
|-------------------------------------------------------|--------------|---------------|
| K051308 | MyLab70 | Esaote, S.p.A |
| K051837 | MyLab90 | Esaote, S.p.A |
| K060827 | MyLab 70, 90 | Esaote, S.p.A |
| K013722 | RVS | Hitachi |

{1}------------------------------------------------

510(k) Summary MyLab70, 90 Systems Esaote, S.p.A.

807.92 (a)(4)

### Device Description

The MyLab70 and MyLab90 system designs remain the same as those previously cleared by FDA via K051837, K051308, and K060827, respectively, except for those features being added via this submission.

They are compact ultrasound systems used to perform diagnostic general ultrasound studies. Their primary modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes and, Tissue Enhancement Imaging (CE), The systems are equipped with an optional LCD Color Display and can drive phased (PA), convex (CA) and linear array (LA) and Doppler probes.

The MyLab70 and MyLab90 systems are able to produce Real Time 2D images and 3D images (in manual mode) with all probes. The MyLab70 and MyLab90 systems are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

### 807.92(a)(5)

### Intended Use(s)

Esaote's Model 6150 (MyLab70) and Model 6100 (MyLab90) are mainframe ultrasound systems used to perform diagnostic general ultrasound studies including Cardine unc Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative: Abdominal, and Other: Urologic. Additionally, the MyLab90 is indicated for Laparoscopic use.

The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasond session. The second modality provides additional security in assessing the morphalogy of the ultrasound image.

Virtual Navigator can be used in the following application: Abdominal, Musculo-skeletal, Urologic, and Vascular.

The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congreent with the current (actual) patient position and shall therefore always been as an additional source of information.

The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

{2}------------------------------------------------

510(k) Summary
MyLab70, 90 Systems
Esaote. S.p.A.

### 807.92(a)(6)

### Technological Characteristics

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

| | Hitachi RVS<br>K013722<br>Predicate | IGSonic<br>BrainLab<br>K012564<br>Predicate | Esaote<br>MyLab 90<br>(6100)<br>K051837 | Esaote<br>MyLab 70<br>(6150)<br>K051308 |
|-------------------------------|-------------------------------------|---------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Virtual Navigator<br>software | YES | YES | To be cleared with<br>this submission | To be cleared<br>with this<br>submission |
| Primary application | Abdominal | NeuroSurgery | Abdominal,<br>Musculoskeletal<br>Conventional and<br>Superficial,<br>Peripheral Vascular<br>and, Urologic | Abdominal,<br>Musculoskeletal<br>Conventional &<br>Superficial.<br>Peripheral<br>Vascular and,<br>Urologic |
| Tracking System | Electromagnetic<br>(Ascension) | Optical (NDI) | Electromagnetic<br>(Ascension) | Electromagnetic<br>(Ascension) |
| Registration<br>Procedure | External Marker<br>- one scan plane | External<br>Marker | External and<br>Internal Marker,<br>one scan plane | External and<br>Internal Marker,<br>one scan plane |

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 5 2008

Esaote, S.p.A. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K081386

Trade/Device Name: MyLab70 and MyLab90 Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: September 9, 2008 Received: September 10, 2008

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 MyLab70 and MyLab90 Systems, as described in your premarket notification:

### Transducer Model Number

| CA 421 | CA 631 | LA 523 |
|--------|--------|--------|
| CA 430 | EC 123 | LA 532 |
| CA 431 | LA 435 | PA 122 |
| CA 621 | LA 522 | PA 230 |

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

{4}------------------------------------------------

Page 2 - Mr. Mark Job

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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 [phone]. 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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] 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 Ms. Lauren Hefner at [phone].

Sincerely yours,

Ioque M. Whay

Joyce M. Whang, Ph.D Acting Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{5}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: MyLab70 and MyLab90 Systems

Indications For Use:

Esaote's Model 6150 (MyLab70) and Model 6100 (MyLab90) are mainframe ultrasound systems 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, and Other: Urologic. Additionally, the MyLab90 is indicated for Laparoscopic use.

The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasound session. The second modality provides additional security in assessing the morphology of the ultrasound image.

Virtual Navigator can be used in the following application: Abdominal, Musculo-skeletal, Urologic, and Vascular.

The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information.

The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

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)

Arzuh Mry

Page 1 of 1

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K08/386

8A

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lyLab90 & 70XV

| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [4] | Color Velocity Mapping (TVM) | Tissue Enhacement Imaging (TEI) | CnTi | Other (specify) |
|-----------------------------------|--------------|--------------|--------------|--------------|---------------|----------------------|--------------|---------------------------------|------------------------------------|--------------|------------------------|
| Ophthalmic | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 7, 8, 9, 12 |
| Fetal | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 7, 8, 9, 12, 13 |
| Abdominal | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 8, 9, 12, 13 |
| Intraoperative (Abdominal) | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 8, 9, 12, 13 |
| Intraoperative Neurological | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 7, 8, 9, 12, 13 |
| Pediatric | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 8, 9, 12, 13 |
| Small Organ [1] | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 8, 9, 12 |
| Neonatal Cephalic | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 8, 9, 12 |
| Adult Cephalic | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 7, 8, 9, 12 |
| Cardiac [2] (MtF369) | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 8, 9, 12 |
| Transesophageal (Cardiac) | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 8, 9, 12, 13 |
| Transesophageal (Non Cardiac) | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 8, 9, 12 |
| Transrectal | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 7, 8, 9, 12, 13, 14 |
| Transvaginal | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 8, 9, 12 |
| Transurethral | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 8, 9, 12, 13 |
| Extravascular | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 7, 8, 9, 12, 13 |
| Peripheral Vascular | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 7, 8, 9, 12, 13 |
| Laparoscopic | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 7, 8, 9, 12, 13 |
| Musculo-skeletal Conventional [3] | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 7, 8, 9, 12, 13 |
| Musculo-skeletal Superficial [3] | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 7, 8, 9, 12, 13 |
| Other (Urological) | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 7, 8, 9, 12, 13 |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler | Combined [4] | Color Velocity<br>Mapping (TVM) | Tissue Enhacement Imaging<br>(TEI) | CnTI | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P<br>K051837 | P<br>K051837 | P<br>K051837 | P<br>K051837 | P<br>K051837 | P<br>K051837 | K051837 | | | K051837 | 6, 8, 9, 12 |
| Abdominal | P<br>K051837 | P<br>K051837 | P<br>K051837 | P<br>K051837 | P<br>K051837 | P<br>K051837 | K051837 | | | K051837 | 6, 8, 9, 12 |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P<br>K051837 | P<br>K051837 | P<br>K051837 | P<br>K051837 | P<br>K051837 | P<br>K051837 | K051837 | | | K051837 | 6, 8, 9, 12 |
| Small Organ [1] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P<br>K051837 | P<br>K051837 | P<br>K051837 | P<br>K051837 | P<br>K051837 | P<br>K051837 | K051837 | | | K051837 | 6, 8, 9, 12 |
| Laparoscopic | | | | | | | | | | K051837 | |
| Musculo-skeletal Conventional [3] | P<br>MtF374 | P<br>MtF374 | P<br>MtF374 | | P<br>MtF374 | P<br>MtF374 | MtF374 | | | MtF374 | 6, 8, 9, 12 |
| Musculo-skeletal Superficial [3] | P<br>MtF374 | P<br>MtF374 | P<br>MtF374 | | P<br>MtF374 | P<br>MtF374 | MtF374 | | | MtF374 | 6, 8, 9, 12 |
| Other (Urological) | P<br>K051837 | P<br>K051837 | P<br>K051837 | | P<br>K051837 | P<br>K051837 | K051837 | | | K051837 | 6, 8, 9, 12 |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler | Combined [4] | Color Velocity<br>Mapping (TVM) | Tissue Enhacement Imaging<br>(TEI) | CnTI | Other<br>(specify) |
| Ophthalmic | P | P | P | | P<br>K051837 | P<br>K051837 | P<br>K051837 | | P<br>K051837 | P<br>K051837 | 6, 8, 9, 12 |
| Fetal | P<br>K051837 | P<br>K051837 | P<br>K051837 | | P<br>K051837 | P<br>K051837 | P<br>K051837 | | P<br>K051837 | P<br>K051837 | 6, 8, 9, 12 |
| Abdominal | P | P | P | | P<br>K051837 | P<br>K051837 | P<br>K051837 | | P<br>K051837 | P<br>K051837 | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P<br>MtF374 | P<br>MtF374 | P<br>MtF374 | | P<br>MtF374 | P<br>MtF374 | P<br>MtF374 | | P<br>MtF374 | P<br>MtF374 | 6,8,9,12 |
| Small Organ (1) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P<br>K051837 | P<br>K051837 | P<br>K051837 | | P<br>K051837 | P<br>K051837 | P<br>K051837 | | P<br>K051837 | P<br>K051837 | 6, 8, 9, 12 |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | P<br>MtF374 | P<br>MtF374 | P<br>MtF374 | | P<br>MtF374 | P<br>MtF374 | P<br>MtF374 | | P<br>MtF374 | P<br>MtF374 | 6,8,9,12 |
| Musculo-skeletal Superficial [3] | P<br>MtF374 | P<br>MtF374 | P<br>MtF374 | | P<br>MtF374 | P<br>MtF374 | P<br>MtF374 | | P<br>MtF374 | P<br>MtF374 | 6,8,9,12 |
| Other (Urological) | P<br>MtF374 | P<br>MtF374 | P<br>MtF374 | | P<br>MtF374 | P<br>MtF374 | P<br>MtF374 | | P<br>MtF374 | P<br>MtF374 | 6,8,9,12 |

Concurrence of CDRH, Office of Device Evaluation (ODE

[7] 4D k060827 & MtF369

[3] Musculo Skeletal includes Nerve Block

MtE377

(14) IMT MtF374

(12) Compound k051837 [9] XView K051837

(Division Sign-Off) F

{7}------------------------------------------------

Lab90 & 70XVG - CA4

Concurrence of CDRH, Office of Device Evaluation (ODE [12] Compound K051837 [4] Combined modes
[4] Combined modes
are:B+M+PW+CFM+PD
[6] 3D K051837

[9] XView - K051837

[3] Musculoskeletal - Nerve Block

TRAINING SAMPLE PICTURE - DOCUMENT TYPE

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386

{8}------------------------------------------------

# MyLab90 & 70XVG - CA43

RESEARCH LIBRARY - PSYCHOLOGY

(3) Musculoskeletal - Nerve Block
(4) 30 Musculoskeletals - Republikas (4) 30 Maria Maria Maria Maria Maria Maria Maria Maria Maria Maria Mari Componima Kossi Componumar (12

e:B+M+PW+CFM+P
rel.sb.krcss

[g]3DK051837

913DK051837
147-171

8J vpan - MTF-374

}Xyview - KD51837

121, Compound K05183

12] Compound K051837

[112] Compound K05183?

L2] Compound K051837

Concurrence of CDRH, Office of Device Evaluation (ODE

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081 386

{9}------------------------------------------------

| 1 | |
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| | |
| 1 | |
| | |
| | |

| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [4] | Color Velocity Mapping (TVM) | Tissue Enhacement Imaging (TEI) | CnTI | Other (specify) | |
|----------------------------------------|--------------|---------|---------|--------|---------------|----------------------|--------------|---------------------------------|------------------------------------|--------|--------------------|---------|
| Ophthalmic | P | P | P | P | P | P | P | P | P | P | 6, 8, 9 | |
| Fetal | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | 6, 8, 9 |
| Abdominal | P | P | P | P | P | P | P | P | P | P | 6, 8, 9 | |
| Intraoperative (Abdominal) | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | 6, 8, 9 |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | P | | 6, 8, 9 |
| Small Organ [1] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | P | | 6, 8, 9 |
| | MtF329 | MtF329 | MtF329 | | MtF329 | MtF329 | MtF329 | | | MtF329 | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | P | P | P | | P | P | P | | MtF329 | P | | 6, 8, 9 |
| | MtF329 | MtF329 | MtF329 | | MtF329 | MtF329 | MtF329 | | | MtF329 | | |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | MtF329 | P | | 6, 8, 9 |
| | MtF329 | MtF329 | MtF329 | | MtF329 | MtF329 | MtF329 | | | MtF329 | | |
| Other (Urological) | P | P | P | | P | P | P | | MtF329 | | | 6, 8, 9 |
| | MtF329 | MtF329 | MtF329 | | MtF329 | MtF329 | MtF329 | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler | Combined [4] | Color Velocity<br>Mapping (TVM) | Tissue Enhacement Imaging<br>(TEI) | CnTI | Other<br>(specify) | |
| Ophthalmic | P | P | P | P | P | P | P | P | P | | | |
| Fetal | P | K051837 | K051837 | | K051837 | K051837 | K051837 | | K051837 | P | 6, 8, 9, 12 | |
| Abdominal | P | K051837 | K051837 | | P | P | P | | K051837 | P | 6, 8, 9, 12 | |
| Intraoperative (Abdominal) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | MtF374 | MtF374 | MtF374 | | MtF374 P | MtF374 P | MtF374 | | MtF374 | P | 6,8,9,12 | |
| Small Organ [1] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | P | K051837 | K051837 | | K051837 | K051837 | K051837 | | K051837 | P | 6, 8, 9, 12 | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | MtF374 | MtF374 | MtF374 | | MtF374 P | MtF374 P | MtF374 | | MtF374 | P | 6,8,9,12 | |
| Musculo-skeletal Superficial [3] | MtF374 | MtF374 | MtF374 | | MtF374 P | MtF374 | MtF374 | | MtF374 | P | 6,8,9.12 | |
| Other (Urological) | P<br>K051837 | K051837 | K051837 | | K051837 | K051837 | KOS1837 | | K051837 | P | 6, 8, 9, 12 | |
| N = New; P = Previously Cleared by FDA | | | | | | | | | | | | |

**New, P = Previously Cleared by FDA**

N = New; P = Previously Cleared
(4) Cousbilled kenetal - Nerve Block
(4) Cousbilled Kenetal - Nerve Block
(4) Cousbilled Marine Marive Block
(6) 3D KOS 1837 (7) 14 - 1
(9)

A] Musculocutaneous NERVE DIVISION
B] Combined mcps

[4] combined modes

[24] COMBINED MODES
are: R-M+PW-CFM+PD

e:B.+M.+PW.+CFM+PD

[8] YBan, MTE 372

pydantic - Mtf 374

31xyiew - KDS1837

Concurrence of CDRH, Office of Device Evaluation (ODE

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386

{10}------------------------------------------------

## yLab90 & 70 XVG - CA62

N = New; P = Previously Cleared by FDA

Intermolecular, Noncovalent

[3] Muscullesteletals: Nerve Block
[6] Muscullest Latin Marve Block
[6] 30 Kost Latin Market Status Creditorial Research
[18] Virgin - TVTF 333 1
[32] Componimo Rouss Brass

[4] Combined modes

e.B+M+PW+CFM+P

[6]3DK051837
RIC,D.M.C.INT

3DK051837

el ypan - MTF374
5D K02857

Oran - NIF 374
XYYview - K051837

[6] Xylem + K051837

[16] XYVIEW - K051837

3] Compound K051837

Concurrence of CDRH, Office of Device Evaluation (ODB

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386

{11}------------------------------------------------

| CA631 |
|---------|
| |
| |
| l |
| |
| 70XVG |
| |
| & |
| |
| |
| MyLab90 |
| |

| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler | Combined [4] | Color Velocity<br>Mapping (TVM) | Tissue Enhacement Imaging<br>(TEI) | CnTl | Other<br>(specify) |
|-----------------------------------|-------------|-------------|-------------|-----|---------------|----------------------|--------------|---------------------------------|------------------------------------|-------------|--------------------|
| Ophthalmic | P | P | P | | P<br>MtF369 | P<br>MtF369 | P<br>MtF369 | | P<br>MtF369 | P | 6,8,9 |
| Fetal | P<br>MtF369 | P<br>MtF369 | P<br>MtF369 | | P<br>MtF369 | P<br>MtF369 | P<br>MtF369 | | P<br>MtF369 | P<br>MtF369 | 6,8,9 |
| Abdominal | P<br>MtF369 | P<br>MtF369 | P<br>MtF369 | | P<br>MtF369 | P<br>MtF369 | P<br>MtF369 | | P<br>MtF369 | P<br>MtF369 | 6,8,9 |
| Intraoperative (Abdominal) | | | | | | | | | | P<br>MtF369 | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P<br>MtF369 | P<br>MtF369 | P<br>MtF369 | | P<br>MtF369 | P<br>MtF369 | P<br>MtF369 | | P<br>MtF369 | P<br>MtF369 | |
| Small Organ [1] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P<br>MtF369 | P<br>MtF369 | P<br>MtF369 | | P<br>MtF369 | P<br>MtF369 | P<br>MtF369 | | P<br>MtF369 | P<br>MtF369 | 6,8,9 |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | P<br>MtF369 | P<br>MtF369 | P<br>MtF369 | | P<br>MtF369 | P<br>MtF369 | P<br>MtF369 | | P<br>MtF369 | P<br>MtF369 | 6,8,9 |
| Musculo-skeletal Superficial [3] | P<br>MtF369 | P<br>MtF369 | P<br>MtF369 | | P<br>MtF369 | P<br>MtF369 | P<br>MtF369 | | P<br>MtF369 | P<br>MtF369 | 6,8,9 |
| Other (Urological) | P<br>MtF369 | P<br>MtF369 | P<br>MtF369 | | P<br>MtF369 | P<br>MtF369 | P<br>MtF369 | | P<br>MtF369 | P<br>MtF369 | 6,8,9 |

= New, P.P., Previously, Cleared by DPC

[3] Musculoskeletal - Nerve Block
(4) Gombined models modes
(4) Gambined (Frodes
(4) Kraft Krailero
(8) VPan - MTT 3374
(8) VPan - MTT 3374
(8) XView - K0513837

4) Combined modes

[4] COMBINED MODES
ars.R+M+PW+FEM+PF

hre.p+M+PY+W+F+M+
rc1.3D K051827

[8] yp3n - MTF32/

YVRAI-MTF374
VVJIAW VUE1937

Concurrence of CDRH, Office of Device Evaluation (ODE

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices K081386
510(k) Number

{12}------------------------------------------------

| t | 1 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | |
| | |
| | |
| | |
| | |
| 1 | |
| =<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| - | |
| | |
| | |
| | |
| | |
| | |
| - | |
| | |
| | |
| | |
| | |
| 1 | |
| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| 1 | |
| | |

| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler | Combined [4] | Color Velocity<br>Mapping (TVM) | Tissue Enhacement<br>Imaging (TEI) | CnTI | Other<br>(specify) |
|-----------------------------------|--------------|--------------|--------------|-----|---------------|----------------------|--------------|---------------------------------|------------------------------------|--------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | K051837<br>P | K051837<br>P | K051837<br>P | | P<br>K051837 | P<br>K051837 | P<br>K051837 | | P<br>K051837 | P<br>K051837 | 6, 8, 9, 12 |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ [1] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | P<br>K051837 | P<br>K051837 | P<br>K051837 | | P<br>K051837 | P<br>K051837 | P<br>K051837 | | P<br>K051837 | KOS1837<br>P | 6, 8, 9, 12 |
| Transvaginal | P<br>K051837 | P<br>K051837 | P<br>K051837 | | P<br>K051837 | P<br>K051837 | P<br>K051837 | | K051837<br>P | K051837<br>P | 6, 8, 9, 12 |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | | |
| Other (Urological) | P<br>K051837 | P | P<br>K051837 | | P | P | P | | P<br>K051837 | P | 6, 8, 9, 12 |

N = New; P = Previously Cleared by

Combined modes are:

[4] Combined modes are:
B+M+PW+CFM+PD
[6] 3D K051837

[6] 3DK051837

[8] ypan - MITF37

[8] VPan - MTF 374
[9] XView - K051837
[12] Compound - K051837
[12] Compound - K051837

COMPOUND REFRACTIVITY

Concurrence of CDRH, Office of Device Evaluation (ODE

Joy
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386

{13}------------------------------------------------

| 1 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| |

| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [4] | Color Velocity Mapping (TVM) | Tissue Enhacement Imaging (TEI) | CnTI | Other (specify) |
|-----------------------------------------------|--------------|--------------|--------------|--------------|------------------|---------------------------|--------------|-----------------------------------------------------|--------------------------------------------------|-----------------------------|---------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | P<br>MtF329 | P<br>MtF329 | | P<br>MtF329 | P<br>MtF329 | MtF329 | | MTF 329<br>P | | 6, 8, 9, 13 |
| Small Organ [1] | | P<br>MtF329 | P<br>MtF329 | | P<br>MtF329 | P<br>MtF329 | MtF329 | | MTF 329<br>P | | 6, 8, 9, 13 |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | P<br>MtF329 | P<br>MtF329 | | P<br>MtF329 | P<br>MtF329 | MtF329 | | MTF 329<br>P | | 6, 8, 9, 13 |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | | P<br>MtF329 | P<br>MtF329 | | P<br>MtF329 | P<br>MtF329 | MtF329 | | MTF 329<br>P | | 6, 8, 9, 13 |
| Musculo-skeletal Superficial [3] | | P<br>MtF329 | P<br>MtF329 | | P<br>MtF329 | P<br>MtF329 | MtF329 | | MTF 329<br>P…