MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100
Device Facts
| Record ID | K051837 |
|---|---|
| Device Name | MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100 |
| Applicant | Esaote, S.p.A. |
| Product Code | IYN · Radiology |
| Decision Date | Jul 20, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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 Story
MyLab90 is a mainframe ultrasound system for diagnostic imaging; supports B-Mode, M-Mode, Doppler, Color Flow Mapping, and Tissue Enhancement Imaging (TEI). Inputs include signals from phased, convex, linear array, and Doppler probes. System features CRT color display, alphanumeric keyboard for patient data/annotations, and DVD-RW storage. Used in clinical settings by healthcare professionals. Data can be exported via LAN to PCs; supports peripherals like VCRs and printers. Provides real-time diagnostic visualization to assist clinicians in patient assessment and clinical decision-making across various anatomical applications.
Clinical Evidence
Bench testing only. No clinical data provided. Substantial equivalence is based on technological comparison, adherence to safety standards (IEC60601-1), and performance of standard ultrasound imaging modes consistent with predicate devices.
Technological Characteristics
Mainframe ultrasound system; CRT display; supports phased, convex, linear, and Doppler probes (1-16 MHz). Modes: B, M, PW, CW, CFM, TEI, CnTI, VPan, TVM, Compound. Connectivity: LAN port, DVD-RW. Electrical safety: IEC60601-1. Acoustic output: Track 3. Weight: 120 kg. Dimensions: 60(w) x 160(h) x 120(d) cm.
Indications for Use
Indicated for diagnostic ultrasound imaging in patients requiring Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal, Abdominal, Fetal, Transvaginal, Transrectal, Adult Cephalic, Pediatric, Laparoscopic, Intraoperative Abdominal, and Urologic examinations.
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
- 7250 Ultrasound Imaging System (K982444)
- 7350 Ultrasound Imaging System (K050326)
- Technos Ultrasound Imaging System (K990360)
- Technos Ultrasound Imaging System (K014168)
- Technos Ultrasound Imaging System (K023255)
- iU22 Ultrasound Imaging System (K042540)
Related Devices
- K051308 — MYLAB 70 ULTRASOUND IMAGING SYSTEM · Esaote, S.p.A. · Jun 1, 2005
- K050326 — 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350 · Esaote, S.p.A. · Feb 28, 2005
- K141486 — MYLABSIX ULTRASOUND SYSTEM · Esaote Europe B.V. · Jul 11, 2014
- K052805 — MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150 · Esaote, S.p.A. · Oct 17, 2005
- K162290 — MyLabSix CrystaLine · Esaote, S.p.A. · Oct 14, 2016
Submission Summary (Full Text)
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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<br>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 System | K982444 |
|----------------|-----------------------------------|---------|
| Esaote, S.p.A. | 7350 Ultrasound Imaging System | K050326 |
| Esaote, S.p.A. | Technos Ultrasound Imaging System | K990360 |
| Esaote, S.p.A. | Technos Ultrasound Imaging System | K014168 |
| Esaote, S.p.A. | Technos Ultrasound Imaging System | K023255 |
| Phillips, Inc. | iU22 Ultrasound Imaging System | K042540 |
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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.
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### (9)(1) 2017-07-26 11:08
# รวมสร้างจรรมหน่ว โหวเรื่องโช
| | | | | | 6100 MyLab 90<br>this submission | Technos<br>(K990360, K014168 &<br>K023255)<br>Esaote, S.p.A. | 7350 MyLab 50<br>(K050326)<br>Esaote, S.p.A | Megas<br>(K982444)<br>Esaote, S.p.A. | iU22 by Philips<br>(K042540)<br>Philips | | |
|----------------------------------------------|-------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------|-------------------------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-----------------------------------------|-----|-----|
| Electrical Safety<br>Ultrasound Safety | IEC60601-1<br>Track 3 (Acoustic Output Display) | Esaote, S.p.A.<br>(K990300, K014108 &<br>K023255)<br>this submission | IEC60601-1<br>Track 3 (Acoustic Output Display) | Esaote, S.p.A.<br> | IEC60601-1<br>Track 3 (Acoustic Output Display) | Modes of operation<br>2D, M-Mode, PW, CW, CFM,<br>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<br>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,<br>Transvaginal | General Purpose, Transrectal,<br>Transvaginal | General Purpose, Transrectal,<br>Transvaginal | General Purpose, Transrectal,<br>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<br>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<br>general purpose measurements | Cardiac, Vascular, OB and<br>general purpose<br>measurements | Cardiac, Vascular, OB and<br>general purpose<br>measurements | Cardiac, Vascular, OB and<br>general purpose measurements | N/A | | |
| Phased Array | YES | YES | YES | Weight | 120 kg | 140 kg | 90 kg | 79 kg<br>portable position:<br>46 (w) x 23.5 (h) x 55 (d) cm<br>use position:<br>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 | | | | | | | | |
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ສາມານສະຖິງ ສືແຫຼ່ງຂໍ້ມູນອື່ນ
.
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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:
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#### Transducer Model Number
| BS230 | LA532 |
|--------|--------|
| CA123 | LP323 |
| CA421 | PA023 |
| CA430 | PA121 |
| CA621 | PA122 |
| EC123 | PA230 |
| IOE323 | TEE022 |
| LA424 | TRT23 |
| LA522 | 2 CW |
| LA523 | 5CW |
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)
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Mod. 6100
KD51837
| | | | | | | Mode of Operation | | | | |
|----------------------------------|---|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | N | N | N | N | N (see<br>Note 1) | N (see<br>Note 2) |
| Abdominal | | N | N | N | N | N | N | N | N (see<br>Note 1) | N (see<br>Note 2) |
| Intraoperative (specify) | | N | N | N | N | N | N | N | N (see<br>Note 1) | N (see<br>Note 2) |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | N | N | N | N | N (see<br>Note 1) | N (see<br>Note 2) |
| Small Organ (specify) | | N | N | N | N | N | N | N | N (see<br>Note 1) | N (see<br>Note 2) |
| Neonatal Cephalic | | N | N | N | N | N | N | N | N (see<br>Note 1) | N (see<br>Note 2) |
| Adult Cephalic | | N | N | N | N | N | N | N | N (see<br>Note 1) | N (see<br>Note 2) |
| Cardiac | | N | N | N | N | N | N | N | N (see<br>Note 1) | N (see<br>Note 2) |
| Transesophageal | | N | N | N | N | N | N | N | N (see<br>Note 1) | N (see<br>Note 2) |
| Transrectal | | N | N | N | N | N | N | N | N (see<br>Note 1) | N (see<br>Note 2) |
| Transvaginal | | N | N | N | N | N | N | N | N (see<br>Note 1) | N (see<br>Note 2) |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | N | N | N | N | N (see<br>Note 1) | N (see<br>Note 2) |
| Laparoscopic | | N | N | N | N | N | N | N | N (see<br>Note 1) | N (see<br>Note 2) |
| Muscolo-skeletal<br>Conventional | | N | N | N | N | N | N | N | N (see<br>Note 1) | N (see<br>Note 2) |
| Muscolo-skeletal Superficial | | N | N | N | N | N | N | N | N (see<br>Note 1) | N (see<br>Note 2) |
| Other (Urological) | | N | N | N | N | N | N | N | N (see<br>Note 1) | N (see<br>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*
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| 100 000<br>S<br>1<br>1 |
|------------------------|
|------------------------|
| Clinical Application | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | N | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | N | N | N | N | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Cardiac | | N | N | N | N | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Muscolo-skeletal<br>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
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| | | Mode of Operation | | | | | | | | | |
|----------------------------------|---|-------------------|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) | |
| Small Organ (specify) | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) | |
| Neonatal Cephalic | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) | |
| Adult Cephalic | | | | | | | | | N (see<br>Note 1) | N (see<br>Note 2) | |
| Cardiac | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) | |
| Laparoscopic | | | | | | | | | | | |
| Muscolo-skeletal<br>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 Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Abdominal | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | N (see<br>Note 1) | N (see<br>Note 2) |
| Pediatric | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Laparoscopic | | | | | | | | | | |
| Muscolo-skeletal<br>Conventional | | | | | | | | | | |
| Muscolo-skeletal Superficial | | | | | | | | | N (see<br>Note 1) | N (see<br>Note 2) |
| Other (Urological) | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>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 Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Abdominal | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Laparoscopic<br>Muscolo-skeletal<br>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<br>ﯽ<br>1 | 1 |
|-------------|---|
| | |
| | | | | | | Mode of Operation | | | | |
|----------------------------------|---|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Abdominal | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Laparoscopic | | | | | | | | | | |
| Muscolo-skeletal<br>Conventional | | | | | | | | | | |
| Muscolo-skeletal Superficial | | | | | | | | | | |
| Other (Urological) | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>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 Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Transvaginal | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Muscolo-skeletal<br>Conventional | | | | | | | | | | |
| Muscolo-skeletal Superficial | | | | | | | | | | |
| Other (Urological) | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>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<br>1 |
|--------|
|--------|
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Small Organ (specify) | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Laparoscopic | | | | | | | | | | |
| Muscolo-skeletal<br>Conventional | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Muscolo-skeletal Superficial | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>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<br>œ |
|--------|
|--------|
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Small Organ (specify) | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Laparoscopic | | | | | | | | | | |
| Muscolo-skeletal<br>Conventional | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Muscolo-skeletal Superficial | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>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<br>1<br>4 | |
|--|-------------|--|
|--|-------------|--|
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Small Organ (specify) | | N | N | N | | N | N | | N (see<br>Note 1) | N (see<br>Note 2) |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral |…
