LogoFDA 510(k) Search
K Number
K051837
Device Name
MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100
Manufacturer
ESAOTE, S.P.A.
Date Cleared
2005-07-20

(14 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Esaote's MyLab90 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Adult Cephalic, Pediatric, Laparoscopic, Intraoperative: Abdominal, and Other: Urologic.
Device Description
The 6100 MyLab 90 is a mainframe ultrasound system used to perform diagnostic The 0100 MfLad 70 15 a manning modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes, Tissue Enhancement Imaging (TEI). The 6100 is equipped with a CRT Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations. The 6100 can drive phased (PA), convex (CA), linear array (LA) and Doppler probes. The 6100 is equipped with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to a Personal Computer via a LAN port. Optional Data can also be berear and of the 6100 include an S-VHS video recorder; a accessory - devices - a rease printer. The 6100 is equipped with an isolation transformer to adequately insulate the system's peripherals.
More Information

K982444, K050326, K990360, K014168, K023255, K042540

Not Found

No
The document mentions "Intelligent Real-Time Image Processing" but does not explicitly state or imply the use of AI or ML algorithms. The description focuses on standard ultrasound modes and hardware features.

No
The device is described as a "mainframe ultrasound system used to perform diagnostic general ultrasound studies," indicating its purpose is for diagnosis rather than therapy.

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used to perform diagnostic general ultrasound studies".

No

The device description clearly outlines a physical mainframe ultrasound system with various hardware components including probes, a CRT display, keyboard, DVD-RW drive, LAN port, and optional accessories like a video recorder and printer. It is not solely software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
  • Device function: The Esaote MyLab90 is an ultrasound system. It uses sound waves to create images of internal body structures. It does not analyze samples taken from the body.
  • Intended Use/Indications for Use: The listed uses are all related to imaging internal anatomy directly, not analyzing biological samples.
  • Device Description: The description focuses on the hardware and imaging capabilities, not on the analysis of biological specimens.

Therefore, the Esaote MyLab90 falls under the category of medical imaging devices, not In Vitro Diagnostics.

N/A

Intended Use / Indications for Use

Esaote's MyLab90 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Adult Cephalic, Pediatric, Laparoscopic, Intraoperative: Abdominal, and Other: Urologic.

Product codes

IYN, IYO, ITX

Device Description

The 6100 MyLab 90 is a mainframe ultrasound system used to perform diagnostic. The 0100 MfLad 70 15 a manning modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes, Tissue Enhancement Imaging (TEI). The 6100 is equipped with a CRT Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations. The 6100 can drive phased (PA), convex (CA), linear array (LA) and Doppler probes. The 6100 is equipped with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to a Personal Computer via a LAN port. Optional Data can also be berear and of the 6100 include an S-VHS video recorder; a accessory - devices - a rease printer. The 6100 is equipped with an isolation transformer to adequately insulate the system's peripherals.

Mentions image processing

YES

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Adult Cephalic, Pediatric, Laparoscopic, Intraoperative: Abdominal, Urologic. Small Organs (thyroid, testicles, penis and breast); Peripheral Vascular (Vein Mapping & Scieroterapy)

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K982444, K050326, K990360, K014168, K023255, K042540

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

0

KL51837

510(k) Summary MyLab90 Ultrasound Imaging System Esaote. S.p.A.

JUL 2005

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

Carri Graham, Official Correspondent The Anson Group 7992 Castleway Drive Indianapolis, Indiana 46250 Phone: (317) 849-1916 x103 Facsimile: (317) 577-9070

Contact Person:Carri Graham
Date:June 24, 2005

807.92(a)(2)

Trade Name:(6100) MyLab90 Ultrasound Imaging System
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)

Esaote, S.p.A.7250 Ultrasound Imaging SystemK982444
Esaote, S.p.A.7350 Ultrasound Imaging SystemK050326
Esaote, S.p.A.Technos Ultrasound Imaging SystemK990360
Esaote, S.p.A.Technos Ultrasound Imaging SystemK014168
Esaote, S.p.A.Technos Ultrasound Imaging SystemK023255
Phillips, Inc.iU22 Ultrasound Imaging SystemK042540

1

510(k) Summary My Lab90 Ultrasound Imaging System Esaote. S.p.A.

807.92 (a)(4)

Device Description

The 6100 MyLab 90 is a mainframe ultrasound system used to perform diagnostic The 0100 MfLad 70 15 a manning modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes, Tissue Enhancement Imaging (TEI). The 6100 is equipped with a CRT Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations.

The 6100 can drive phased (PA), convex (CA), linear array (LA) and Doppler probes.

The 6100 is equipped with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to a Personal Computer via a LAN port. Optional Data can also be berear and of the 6100 include an S-VHS video recorder; a accessory - devices - a rease printer. The 6100 is equipped with an isolation transformer to adequately insulate the system's peripherals.

807.92(a)(5)

Intended Use(s)

Esaote's MyLab90 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Adult Cephalic, Pediatric, Laparoscopic, Intraoperative: Abdominal, and Other: Urologic.

2

ແລະຣັຽ ສີພາສີຂະແຖງ punose.ນິຖຸງ ບຸດຕຣສະມາຊາ ບຸດຕະສະ

ເຄລາຣ (ຊອງສາຕາ

(9)(1) 2017-07-26 11:08

รวมสร้างจรรมหน่ว โหวเรื่องโช

| | | | | | 6100 MyLab 90
this submission | Technos
(K990360, K014168 &
K023255)
Esaote, S.p.A. | 7350 MyLab 50
(K050326)
Esaote, S.p.A | Megas
(K982444)
Esaote, S.p.A. | iU22 by Philips
(K042540)
Philips | | |
|----------------------------------------------|-------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------|-------------------------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-----------------------------------------|-----|-----|
| Electrical Safety
Ultrasound Safety | IEC60601-1
Track 3 (Acoustic Output Display) | Esaote, S.p.A.
(K990300, K014108 &
K023255)
this submission | IEC60601-1
Track 3 (Acoustic Output Display) | Esaote, S.p.A.
| IEC60601-1
Track 3 (Acoustic Output Display) | Modes of operation
2D, M-Mode, PW, CW, CFM,
Amplitude Doppler (PD), TEI | YES | YES | YES | YES | YES |
| Indication for Use | | | | | | CnTI | YES | YES | YES | YES | YES |
| OB/Fetal | YES | YES | YES | TVM | YES | YES | YES | NO | YES | | |
| Abdominal | YES | YES | YES | VPAN | YES | YES | NO | NO | YES | | |
| Intraoperative: Abdominal | YES | YES | NO | Compound Imaging | YES | YES | NO | NO | YES | | |
| Pediatric | YES | YES | YES | 3D | YES | YES | YES | YES | YES | | |
| Small organ | YES | YES | YES | Imaging Frequencies | 1 - 16 MHz | 1.5 - 16 MHz | 2 - 10 MHz | 2 - 10 MHz | N/A | | |
| Neonatal Cephalic | YES | YES | YES | CFM/Doppler Frequencies | 2 - 12 MHz | 2 - 12 MHz | 2 - 8 MHz | 2 - 5 MHz | N/A | | |
| Adult Cephalic | YES | YES | YES | Tissue Velocity Mapping feature | YES | YES | YES | NO | NO | | |
| Cardiac | YES | YES | YES | Intelligent Real-Time Image
Processing | YES | NO | NO | NO | YES | | |
| Transesophageal | YES | YES | YES | Biopsy Guidance | YES | YES | YES | N/A | N/A | | |
| Transrectal | YES | YES | YES | Biopsy Intended Uses | General Purpose, Transrectal,
Transvaginal | General Purpose, Transrectal,
Transvaginal | General Purpose, Transrectal,
Transvaginal | General Purpose, Transrectal,
Transvaginal | N/A | | |
| Transvaginal | YES | YES | YES | Display type | CRT | CRT | CRT | LCD or CRT (optional) | LCD | | |
| Peripheral Vascular | YES | YES | YES | Display Standard | SVGA | SVGA | SVGA | SVGA | N/A | | |
| Laparoscopic | YES | YES | NO | Digital Archival Capabilities | YES | YES | YES | YES | YES | | |
| Musculoskeletal (conventional & superficial) | YES | YES | YES | DICOM Classes: | Media Storage, Storage SCU | Media Storage, Storage SCU | Media Storage, Storage
SCU | Media Storage, Storage SCU | N/A | | |
| Other: Urological | YES | YES | NO | VCR/Page Printer | YES | YES | YES | YES | YES | | |
| Probe Technology | | | | M&A Capabilities | Cardiac, Vascular, OB and
general purpose measurements | Cardiac, Vascular, OB and
general purpose
measurements | Cardiac, Vascular, OB and
general purpose
measurements | Cardiac, Vascular, OB and
general purpose measurements | N/A | | |
| Phased Array | YES | YES | YES | Weight | 120 kg | 140 kg | 90 kg | 79 kg
portable position:
46 (w) x 23.5 (h) x 55 (d) cm
use position:
46 (w) x 23.5 (h) x 68 (d) cm | N/A | | |
| Linear Array | YES | YES | YES | Dimensions | 60(w) x 160(h) x 120(d) cm | 60(w) x 160(h) x 105(d) cm | 60(w) x 155(h) x 90(d) cm | | N/A | | |
| Convex Array | YES | YES | YES | | | | | | | | |
| Doppler Probes | YES | YES | YES | | | | | | | | |
| Bi-Scan | YES | NO | NO | | | | | | | | |

3

ແລະຣັດ ສີແຜນການເທດລາວໄທ ນາງ ຄ.ສ. 1974 ເດີຣ໌ ແລະ ແລະສັງ

ສາມານສະຖິງ ສືແຫຼ່ງຂໍ້ມູນອື່ນ

.

4

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other, with flowing lines beneath them.

JUL 20 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Esaote, S.p.A. % Ms. Carri Graham Consultant The Anson Group 7992 Castleway Drive INDIANAPOLIS IN 46250

Re: K051837

Trade Name: MyLab 90 Ultrasound Imaging Systems, Model 6100 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 5, 2005 Received: July 6, 2005

Dear Ms. Graham:

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 MyLab 90 Ultrasound Imaging Systems, Model 6100, as described in your premarket notification:

5

Transducer Model Number

BS230LA532
CA123LP323
CA421PA023
CA430PA121
CA621PA122
EC123PA230
IOE323TEE022
LA424TRT23
LA5222 CW
LA5235CW

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is elassified (660 additional controls. Existing major regulations affecting your devices a It may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA cun oe found in the Overnments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of actived that I Dr is as an that your device complies with other requirements of the Act that I DA has made a acterimentions administered by other Federal agencies. You must of ally I cactares and regalations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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 In Appendix U, (encrosou) of the Sames tic Ultrasound Systems and Transducers." If the special beeking Mantening Orcultains 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 The special report blocked "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

6

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 If you desire specific at notiation at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Whisolanding by reference to preneesnonsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 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 Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

NancyCbrogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

7

Mod. 6100

KD51837

Mode of Operation
Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
FetalNNNNNNNN (see
Note 1)N (see
Note 2)
AbdominalNNNNNNNN (see
Note 1)N (see
Note 2)
Intraoperative (specify)NNNNNNNN (see
Note 1)N (see
Note 2)
Intraoperative Neurological
PediatricNNNNNNNN (see
Note 1)N (see
Note 2)
Small Organ (specify)NNNNNNNN (see
Note 1)N (see
Note 2)
Neonatal CephalicNNNNNNNN (see
Note 1)N (see
Note 2)
Adult CephalicNNNNNNNN (see
Note 1)N (see
Note 2)
CardiacNNNNNNNN (see
Note 1)N (see
Note 2)
TransesophagealNNNNNNNN (see
Note 1)N (see
Note 2)
TransrectalNNNNNNNN (see
Note 1)N (see
Note 2)
TransvaginalNNNNNNNN (see
Note 1)N (see
Note 2)
Transurethral
Intravascular
Peripheral VascularNNNNNNNN (see
Note 1)N (see
Note 2)
LaparoscopicNNNNNNNN (see
Note 1)N (see
Note 2)
Muscolo-skeletal
ConventionalNNNNNNNN (see
Note 1)N (see
Note 2)
Muscolo-skeletal SuperficialNNNNNNNN (see
Note 1)N (see
Note 2)
Other (Urological)NNNNNNNN (see
Note 1)N (see
Note 2)

Additional Comments: Small Organs (thyroid, testicles, penis and breast); Peripheral Vascular to include Vein Mapping & Scieroterapy Intraoperative_(Abdominal)

  • Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.
    Note (2): TEI (Tissue Enhanced Imaging) mode CnTI (Contrast Media) 30 VPan TVM (Tissue Velocity Mapping) Compound

Marci C. Brossdon
(Division Sign-Off)

Divisio ductive and Radiological Devices 510(k) Number

Prescription Use

8

| 100 000
S
1

1
------------------------
Clinical ApplicationMode of Operation
ABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
AbdominalNNNNNNN (see
Note 1)N (see
Note 2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult CephalicNNNNNNN (see
Note 1)N (see
Note 2)
CardiacNNNNNNN (see
Note 1)N (see
Note 2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Muscolo-skeletal
Conventional
Muscolo-skeletal Superficial
Other (Urological)

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Note (2): TEI (Tissue Enhanced Imaging) mode CnTI (Contrast Media)

3D VPan Compound

Nancy C. Hogdon

(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number _

Prescription Use

2

9

Mode of Operation
Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
AbdominalNNNNNN (see
Note 1)N (see
Note 2)
Intraoperative (specify)
Intraoperative Neurological
PediatricNNNNNN (see
Note 1)N (see
Note 2)
Small Organ (specify)NNNNNN (see
Note 1)N (see
Note 2)
Neonatal CephalicNNNNNN (see
Note 1)N (see
Note 2)
Adult CephalicN (see
Note 1)N (see
Note 2)
CardiacNNNNNN (see
Note 1)N (see
Note 2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNN (see
Note 1)N (see
Note 2)
Laparoscopic
Muscolo-skeletal
Conventional
Muscolo-skeletal Superficial
Other (Urological)

Additional Comments:

Small Organs (thyroid, testicles, penis and breast);

Peripheral Vascular to include Vein Mapping & Scieroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Nancyc Broylon

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number _

Prescription Use

10

Mode of Operation
Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
FetalNNNNNN (see
Note 1)N (see
Note 2)
AbdominalNNNNNN (see
Note 1)N (see
Note 2)
Intraoperative (specify)
Intraoperative NeurologicalN (see
Note 1)N (see
Note 2)
PediatricNNNNNN (see
Note 1)N (see
Note 2)
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNN (see
Note 1)N (see
Note 2)
Laparoscopic
Muscolo-skeletal
Conventional
Muscolo-skeletal SuperficialN (see
Note 1)N (see
Note 2)
Other (Urological)NNNNNN (see
Note 1)N (see
Note 2)

Additional Comments:

Peripheral Vascular to include Vein Mapping & Scleroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Nancy Choydon

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

Prescription Use

11

Mode of Operation
Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
FetalNNNNNN (see
Note 1)N (see
Note 2)
AbdominalNNNNNN (see
Note 1)N (see
Note 2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNN (see
Note 1)N (see
Note 2)
Laparoscopic
Muscolo-skeletal
Conventional
Muscolo-skeletal Superficial
Other (Urological)

Additional Comments:

Peripheral Vascular to include Vein Mapping & Scieroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Nancy C. hogdon

(Division Sign-Off) Division of Reproductive, Abdomin anr Radiological Devices 131 ·· lik, Number _______________________________________________________________________________________________________________________________________________________________

Prescription Use

12

| 6
ﯽ

11
Mode of Operation
Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
FetalNNNNNN (see
Note 1)N (see
Note 2)
AbdominalNNNNNN (see
Note 1)N (see
Note 2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNN (see
Note 1)N (see
Note 2)
Laparoscopic
Muscolo-skeletal
Conventional
Muscolo-skeletal Superficial
Other (Urological)NNNNNN (see
Note 1)N (see
Note 2)

Additional Comments:

Peripheral Vascular to include Vein Mapping & Scieroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CFM+PD, where only one mode is live; Ooklakions: uny oombination B+CFM+PW where all single modes are live.

  • Note (2): TEI (Tissue Enhanced Imaging) mode CnTI (Contrast Media) 3D VPan Compound
    Nancy C Brogdon

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

Prescription Use

13

Mode of Operation
Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
FetalNNNNNN (see
Note 1)N (see
Note 2)
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
TransrectalNNNNNN (see
Note 1)N (see
Note 2)
TransvaginalNNNNNN (see
Note 1)N (see
Note 2)
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Muscolo-skeletal
Conventional
Muscolo-skeletal Superficial
Other (Urological)NNNNNN (see
Note 1)N (see
Note 2)

Note (1): Conbinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Note (2): TEI (Tissue Enhanced Imaging) mode CnTI (Contrast Media)

  • 30
    VPan
    Compound

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use

14

| 1

1
--------
Mode of Operation
Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)NNNNNN (see
Note 1)N (see
Note 2)
Intraoperative Neurological
PediatricNNNNNN (see
Note 1)N (see
Note 2)
Small Organ (specify)NNNNNN (see
Note 1)N (see
Note 2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNN (see
Note 1)N (see
Note 2)
Laparoscopic
Muscolo-skeletal
ConventionalNNNNNN (see
Note 1)N (see
Note 2)
Muscolo-skeletal SuperficialNNNNNN (see
Note 1)N (see
Note 2)
Other (Urological)

Additional Comments: Small Organs (thyroid, testicles, penis and breast); Peripheral Vascular to include Vein Mapping & Scieroterapy Intraoperative (Abdominal)

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Nancy C. Brogdon

(Division Sign-Off) Abdomin Division of Reproductive, and Radiological Devices Ki 510(k) Number __

Prescription Use

15

| 0

œ
--------
Mode of Operation
Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
PediatricNNNNNN (see
Note 1)N (see
Note 2)
Small Organ (specify)NNNNNN (see
Note 1)N (see
Note 2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNN (see
Note 1)N (see
Note 2)
Laparoscopic
Muscolo-skeletal
ConventionalNNNNNN (see
Note 1)N (see
Note 2)
Muscolo-skeletal SuperficialNNNNNN (see
Note 1)N (see
Note 2)
Other (Urological)

Additional Comments:

Additional Organs (thereid, testicles, penis and breast); Peripheral Vascular to include Vein Mapping & Scieroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices K051837 ! (1)(k) Number ______________________________________________________________________________________________________________________________________________________________

Prescription Use

16

| | 1
1
4 | |

-----------------
Mode of Operation
Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
PediatricNNNNNN (see
Note 1)N (see
Note 2)
Small Organ (specify)NNNNNN (see
Note 1)N (see
Note 2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNN (see
Note 1)N (see
Note 2)
Laparoscopic
Muscolo-skeletal
ConventionalNNNNNN (see
Note 1)N (see
Note 2)
Muscolo-skeletal SuperficialNNNNNN (see
Note 1)N (see
Note 2)
Other (Urological)

Additional Comments:

Small Organs (thyroid, testicles, penis and breast); Peripheral Vascular to include Vein Mapping & Scleroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Nancy C. Broadon

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

Transcription Use

17

|--|--|

Mode of Operation
Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
PediatricNNNNNN (see
Note 1)N (see
Note 2)
Small Organ (specify)NNNNNN (see
Note 1)N (see
Note 2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNN (see
Note 1)N (see
Note 2)
Muscolo-skeletal
ConventionalNNNNNN (see
Note 1)N (see
Note 2)
Muscolo-skeletal SuperficialNNNNNN (see
Note 1)N (see
Note 2)
Other (Urological)

Additional Comments:

Small Organs (thyroid, testicles, penis and breast); Peripheral Vascular to include Vein Mapping & Scleroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Nancy Croglon
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 5 10(k) Number _ 1,05

....mission 6152.

18

|--|--|

Mode of Operation
Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
PediatricNNNNNN (see
Note 1)N (see
Note 2)
Small Organ (specify)NNNNNN (see
Note 1)N (see
Note 2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNN (see
Note 1)N (see
Note 2)
Laparoscopic
Muscolo-skeletal
Conventional
Muscolo-skeletal Superficial
Other (Urological)

Additional Comments: Small Organs (thyroid, testicles, penis and breast); Peripheral Vascular to include Vein Mapping & Scleroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+CFM, B+CFM+PW where all single modes are live.
Note (2): TEI (Tissue Enhanced Imaging) mode

CnTI (Contrast Media) 30 VPan Compound

Nancy brondon

Division Sign-Off

timelon of Reproductive, Abdominal, . Padiological Devices · : )(k) Number _

Description C52

19

Am
----
Mode of Operation
Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
LaparoscopicNNNNNNN (see
Note 1)N (see
Note 2)
Muscolo-skeletal
Conventional
Muscolo-skeletal Superficial
Other (Urological)

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Note (2): TEI (Tissue Enhanced Imaging) mode CnTI (Contrast Media) 3D

  • VPan Compound
    Nancy C. hogdon
    (Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __ 13

Description #2

20

Mode of Operation
Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
PediatricNNNNNNN (see
Note 1)N (see
Note 2)
Small Organ (specify)
Neonatal CephalicNNNNNNN (see
Note 1)N (see
Note 2)
Adult Cephalic
CardiacNNNNNNN (see
Note 1)N (see
Note 2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNNN (see
Note 1)N (see
Note 2)
Laparoscopic
Muscolo-skeletal
Conventional
Muscolo-skeletal Superficial
Other (Urological)

Additional Comments: Peripheral Vascular to include Vein Mapping & Scleroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Note (2): TEI (Tissue Enhanced Imaging) mode CnTI (Contrast Media) 30 VPan TVM (Tissue Velocity Mapping) Compound

Nancy C. Brogdon

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

21

C1
------
Mode of Operation
Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
AbdominalNNNNNNN (see
Note 1)N (see
Note 2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult CephalicN (see
Note 1)N (see
Note 2)
CardiacNNNNNNN (see
Note 1)N (see
Note 2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Muscolo-skeletal
Conventional
Muscolo-skeletal Superficial
Other (Urological)

Note (1): Combinations: any combination of the following modes: B+M+PW+CFM+PD, where only one mode is live; .

CnTI (Contrast Media)

3D VPan TVM (Tissue Velocity Mapping) Compound

Nancy Boydon
(Division Sign-Off)

Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _

Commission #32

22

1
0
Mode of Operation
Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
PediatricNNNNNNN (see
Note 1)N (see
Note 2)
Small Organ (specify)
Neonatal CephalicNNNNNNN (see
Note 1)N (see
Note 2)
Adult Cephalic
CardiacNNNNNNN (see
Note 1)N (see
Note 2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNNN (see
Note 1)N (see
Note 2)
Laparoscopic
Muscolo-skeletal
Conventional
Muscolo-skeletal Superficial
Other (Urological)

Additional Comments:

Peripheral Vascular to include Vein Mapping & Scieroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Note (2): TE1 (Tissue Enhanced Imaging) mode CnTI (Contrast Media)

3D VPan TVM (Tissue Velocity Mapping) Compound

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdomi and Radiological Devices 510(k) Number

Number

  • 3 --------------------------------------------------------------------------------------------------------------------------------------------------------------------------V

23

| 6
0
4.44

1
-----------------------
Mode of Operation
Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
AbdominalNNNNNNN (see
Note 1)N (see
Note 2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal CephalicN (see
Note 1)N (see
Note 2)
Adult CephalicNNNNNNN (see
Note 1)N (see
Note 2)
CardiacNNNNNNN (see
Note 1)N (see
Note 2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Muscolo-skeletal
Conventional
Muscolo-skeletal Superficial
Other (Urological)

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Note (2): TEI (Tissue Enhanced Imaging) mode

CnTI (Contrast Media) 30 VPan TVM (Tissue Velocity Mapping) Compound

Nancy Brogdon
(Division Sign-Off)

Division of Reproductive, Abdomina and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 1051831 17 ---

24

TEE022

| Clinical Application | Mode of Operation | | | | | | | | Combined
(specify) | Other
(specify) |
|----------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| | A | B | M | PWD
(PW) | CWD
(CW) | Color
Doppler
(CFM) | Amplitude
Doppler
(PD) | Color
Velocity
Imaging | | |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | N | N | N | N | | N (see
Note 1) | N (see
Note 2) |
| Transesophageal | | N | N | N | N | N | N | | N (see
Note 1) | N (see
Note 2) |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Muscolo-skeletal
Conventional | | | | | | | | | | |
| Muscolo-skeletal Superficial | | | | | | | | | | |

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Note (2): TEI (Tissue Enhanced Imaging) mode

CnTI (Contrast Media) 30 VPan TVM (Tissue Velocity Mapping) Compound

V

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices KO51837 510(k) Number _

C. 22-2002-52

25

Clinical ApplicationMode of Operation
ABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
TransesophagealN (see
Note 1)N (see
Note 2)
TransrectalNNNNNN (see
Note 1)N (see
Note 2)
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Muscolo-skeletal
Conventional
Muscolo-skeletal SuperficialN (see
Note 1)N (see
Note 2)

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live;
Childer (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) ( Oombinational only on J O+M, B+CFM+PW where all single modes are live.

Note (2): TE1 (Tissue Enhanced Imaging) mode

  • CnTI (Contrast Media) 30 VPan Compound
    Nancy C. Brogdon

Onlinision Sign-Off) "isson of Reproductive, Abdominal, ്ങ Radiological Devices ¥051837 10(k) Number -----------------------------------------------------------------------------------------------------------------------------------------------------------------

26

Mode of Operation
Clinical ApplicationABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
CardiacN
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Muscolo-skeletal
Conventional
Muscolo-skeletal Superficial
Other (specify)

Other (Orological)
N= new indication; P= previously cleared by FDA; E= added under Appendix E

Nancy C. Hogdon

(Division Sign-Off)
Division of Reproductive, Abdominal
and Radiological Devices KUSI 837 510(k) Number ________________________________________________________________________________________________________________________________________________________________

27

Clinical ApplicationMode of Operation
ABMPWD
(PW)CWD
(CW)Color
Doppler
(CFM)Amplitude
Doppler
(PD)Color
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularN
Laparoscopic
Muscolo-skeletal
Conventional
Muscolo-skeletal Superficial

Other \Urological/
N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

Additional Commonta:
Penpheral Vascular to include Vein Mapping & Scieroterapy

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdominal ind Radiological Devices ் 10(k) Number _______________________________________________________________________________________________________________________________________________________________

initialization

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