MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM
Device Facts
| Record ID | K053154 |
|---|---|
| Device Name | MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM |
| Applicant | Pie Medical |
| Product Code | IYN · Radiology |
| Decision Date | Dec 16, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Esaote's MyLab15/MyLab20 is a compact console ultrasound system intended to be used by a physician to perform general diagnostic ultrasound studies including Fetal, Abdominal, Pediatric, Small organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal (Conventional and Superficial).
Device Story
MyLab15/20 is a compact console ultrasound system for general diagnostic imaging. Inputs include ultrasound signals from various transducers (linear, convex, endocavity). System processes signals using B-Mode, M-Mode, PW Doppler, Color Flow Mapping, and Tissue Enhancement Imaging (TEI). Produces 2D, 3D (manual), and real-time 4D images (with BC432P probe). Used in clinical settings by physicians for diagnostic studies. Output displayed on 15-inch CRT/LCD monitor; supports digital archival, VCR, and printer integration. Assists clinicians in visualizing anatomy and pathology to inform diagnostic decision-making.
Clinical Evidence
Bench testing only. No clinical data provided. Safety and effectiveness established through comparison of technological characteristics, imaging modes, and compliance with electrical safety standards (EN60601-1).
Technological Characteristics
Compact console ultrasound system. Transducers: linear, convex, endocavity, mechanically driven 3D convex array. Imaging modes: B, M, PW Doppler, Color Flow, Amplitude Doppler, TEI, 3D/4D. 15-inch CRT/LCD monitor. Connectivity: digital archival, VCR/printer support. Electrical safety: EN60601-1. Software: embedded system for image processing and control.
Indications for Use
Indicated for physicians performing general diagnostic ultrasound studies in fetal, abdominal, pediatric, small organ (thyroid, breast, testicles), neonatal cephalic, cardiac, transrectal, transvaginal, peripheral vascular, and musculoskeletal (conventional and superficial) applications.
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
- Technos Esaote, S.p.A. (K014168)
- MyLab15/20 Ultrasound System Pie Medical (K043588)
- 8000Live Medison (K043455)
- G50 Siemens (K040060)
Related Devices
- K061755 — MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM · Esaote Europe B.V. · Aug 7, 2006
- K070903 — MYLAB40 · Esaote Europe B.V. · Jul 2, 2007
- K071996 — MYLAB30, MODEL 7300 · Esaote, S.p.A. · Aug 3, 2007
- K060827 — MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100 · Esaote, S.p.A. · May 19, 2006
- K051308 — MYLAB 70 ULTRASOUND IMAGING SYSTEM · Esaote, S.p.A. · Jun 1, 2005
Submission Summary (Full Text)
{0}------------------------------------------------
510(k) Summary MyLab15/20 Just3D/4D Pie Medical
DEC 1 6 2005
Ko53/54
# 510(k) Summary
The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR¶807.92(a).
807.92(a)(1)
#### Submitter Information
| Carri Graham, Official Correspondent<br>7992 Castleway Drive<br>Indianapolis, IN 46250<br>Phone: | (317) 849-1916 |
|--------------------------------------------------------------------------------------------------|-------------------|
| Facsimile: | (317) 577-9070 |
| Contact Person: | Carri Graham |
| Date: | November 10, 2005 |
807.92(a)(2)
| Trade Name: | MyLab15/20 - Just3D and Just 4D Ultrasound System |
|-------------------------|-----------------------------------------------------------------------------------------------------|
| Common Name: | Ultrasound Imaging System |
| Classification Name(s): | Ultrasonic pulsed echo imaging system 892.1560<br>Ultrasonic pulsed Doppler imaging system 832.1550 |
| Classification Number: | 90IYO<br>90IYN |
807.92(a)(3)
Predicate Device(s)
| K014168 | Technos Esaote, S.p.A. |
|---------|------------------------------------------|
| K043588 | MyLab15/20 Ultrasound System Pie Medical |
| K043455 | 8000Live Medison |
| K040060 | G50 Siemens |
Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.
{1}------------------------------------------------
510(k) Summary MyLab15/20 Just3D/4D Pie Medical
#### Device Description 807.92(a)(4)
The MyLab15/20 is a compact console ultrasound system used to perform general The WYLao is a coulies. Its primary modes of operation are: B-Mode, M-Mode, PW Glaghoone and Color Flow Mapping and Tissue Enhancement Imaging (TEI). Dopper and Color 110 mages and time 2D images and 3D images (in manual mode) with all probes. The system, in combination with the probe BC432P, offers the possibility to also produce automatic 3D and real time 4D images
#### Intended Use(s) 807.92(a)(5)
Esaote's MyLab15/MyLab20 is a compact console ultrasound system intended to be used by a physician to perform general diagnostic ultrasound studies including Fetal, A bdominal, Pediatric, Small organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal (Conventional and Superficial).
{2}------------------------------------------------
| General<br>Characteristics | Esaote MyLab15/20 | Medison 8000Live<br>(k043455) | Siemens G50<br>(k040060) |
|-------------------------------------------------------|-------------------|-------------------------------|--------------------------|
| | Applications | | |
| Fetal | Yes | Yes | Yes |
| Abdominal | Yes | Yes | Yes |
| Pediatric | Yes | Yes | Yes |
| Small Organ | Yes | Yes | Yes |
| Neonatal Cephalic | Yes | Yes | Yes |
| Cardiac | Yes | Yes | Yes |
| Transrectal | Yes | Yes | Yes |
| Transvaginal | Yes | Yes | Yes |
| Peripheral Vascular | Yes | Yes | Yes |
| Musculo-skeletal<br>(Conventional and<br>superficial) | Yes | Yes | Yes |
# Comparison Chart for Substantial Equivalence
{3}------------------------------------------------
# 510(k) Summary MyLab15/20 Just3D/4D
Pie Medical
| Pie Medical | | | |
|----------------------------------|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| General<br>Characteristics | Esaote MyLab15/20 | Medison 8000Live<br>(k043455) | Siemens G50<br>(k040060) |
| | Transducer Type | | |
| Linear | Yes | Yes | Yes |
| Convex | Yes | Yes | Yes |
| Phased array | No | Yes | Yes |
| 2D Freq MHz | 2.7 - 15 | 1 - 20 | 2 - 12 |
| Multifrequency | Yes | Yes | Yes |
| Special probes | • Endocavity probe<br>• Mechanically<br>Driven 3D Convex<br>Array | • Endocavity probe<br>• Mechanically<br>Driven 3D<br>Convex Array<br>• CW Doppler<br>Probe | • Endocavity probe<br>• Mechanically<br>Driven 3D<br>Convex Array<br>• Laparoscopic<br>CW Doppler<br>Probe |
| | Biopsy attachments | | |
| Convex | Yes | Yes | Yes |
| Linear | Yes | Yes | Yes |
| | Imaging modes | | |
| Real Time 2D | Yes | Yes | Yes |
| M-mode | Yes | Yes | Yes |
| PW Doppler | Yes | Yes | Yes |
| CW Doppler | No | Yes | Yes |
| CFM Doppler | Yes | Yes | Yes |
| Amplitude Doppler | Yes | Yes | Yes |
| Triplex | Yes | Yes | Yes |
| 3D/4D | Yes | Yes | Yes |
| Monitor size (inches) | • 15" CRT<br>monitor<br>• 15" LCD | 15" Color VGA<br>CRT Monitor | 15" CRT monitor |
| ECG | Optional | Optional | Optional |
| Digital archival<br>capabilities | Yes | Yes | Yes |
| VCR & Video<br>printers | Yes | Yes | Yes |
| M&A capabilities | Yes | Yes | Yes |
| | Safety | | |
| Electrical safety | EN60601-1 | EN60601-1 | EN60601-1 |
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus with three snakes intertwined around a staff. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the logo.
DEC 16 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pie Medical % Carri Graham The Anson Group 7992 Castleway Drive INDIANAPOLIS IN 46250
K053154 Re:
K033154
Trade Name: MyLab15/MyLab20 Ultrasound Imaging System (with 3D/4D Imaging Option) Regulation Number: 21 CFR 892.1550/1560/1570 Regulation Number: 21 CTN 072.1556.1556.1578.15 157.11.1 Ultrasonic pulsed echo
Regulation Name: Ultrasonic pulsed Doppler imaging provinstransducer imaging system; Diagnostic ultrasonic transducer. Regulatory Class: Il Product Code: IYN; IYO; ITX
Dated: November 10, 2005 Received: November 15, 2005
Dear Ms. Graham:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above We have reviewed your Section 510(x) premixally equivalens for use stated in the enclosure)
and we have determined the device is substantially equivalens for use stated in th and we have determined the devices marketed in interstate conneces prior to May 28, 1976, the enactment date to legally marketed predicate devices that have been recessified in accordance with the provisions
of the Medical Device Amendments, or to devices that have been receive syst of the Medical Device Amendments, or to devices that hard of the device, subject to the of the Federal Food, Drug, and Costlette Act (rec). general controls provisions of the Act. "The general connect processes, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the This determination of substantal equivalor upprise to as ed ed ed to be premarket notification:
Transducer Model Numbers
#### LA523; LA424; CA421P; CA421; CA621; BC432P; EC123; E8-5 R10
If your device is classified (see above) into either class III (PMA). III (PMA), it may be subject in the Code of Federal If your device is classified (see adove) natio cities in (course can be found in the Code of Federal to such additional controls. Existing major regulations an ouncements concerning your device in the Federal Register.
device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence of the Art or any Federal statures and Please be advised that FDA s Issualitar equirements of the Act of the Act or any Federal statutes and made a determination that your device comples with all the Act at 's requirements, including, including, including, including, regulations administered by other Federal agencies: You Multing (21 CFR Part 801); good manufacturing
but not limited to: registration and listing (21 CFR Part 807); and if but not limited to: registration and nismig (C.) C.F. Part 80); and I CFR Part 820); and If applicable, the
practice requirements as set forth in the quality of the A.S.A. A. practice requirements as sectorin in the quality of the Act); 21 CFR 1000-1050.
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-105
{5}------------------------------------------------
#### Page 2 - Ms. Graham
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, This determination of substantial equivalence is gamed on the information, including acoustic you submit a postclearance special report. "Ins report is G, (enclosed) of the Center's output measurements based on production this doviets, requested in 1 playessite Ultrasound September 30, 1997 " Information for wanting announg unaceptable values (e.g., acoustic Systems and Transducers. III the special report is meomplete or contaction units which as a output grouter considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently The special report 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 premarke in a elessification. This letter will allow you to begil marketing your device us cosenoed any an possible 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 If you desire specific advice for your device the regulation entitled, "Misbranding by reference to Office of Compliance at (240) 270-0120. You may obtain other general information on your responsibilities premarket notification" (21CPK Patt 807.97) - Tou may Count of Consumer Assistance at its toll-free under (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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
{6}------------------------------------------------
## 4.3 Indications for Use
| | | | | | | | Mode of Operation | | | |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | P [2] | P[3], N[4],<br>N[5] |
| Abdominal | | P | P | P | | P | P | | P [2] | P[3], N[4],<br>N[5] |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | P [2] | P[3], N[4],<br>N[5] |
| Small Organ (specify) [1] | | P | P | P | | P | P | | P [2] | P[3], N[4] |
| Neonatal Cephalic | | P | P | P | | P | P | | P [2] | P[3], N[4] |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | | P | P | | P [2] | P[3] |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | P [2] | P[3], N[4] |
| Transvaginal | | P | P | P | | P | P | | P [2] | P[3], N[4] |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | | P [2] | P[3], N[4] |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | P [2] | P[3]. N[4] |
| Musculo-skeletal Superficial | | P | P | P | | P | P | | P [2] | P[3]. N[4] |
| Other (specify) | | | | | | | | | | |
The following table provides the intended clinical use for the MyLab15/20:
N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:
[1] Small organs include Thyroid, Breast and Testicles.
[1] Smart organs modes: B+M+PW+ CFM+Amplitude Doppler
- [3] Tissue Enhancement Imaging (TEI)
[4] 3D Imaging
[5] 4D Imaging
Nancy C Gordon
(Division Sign (Off) Division il Reproductive, Abdominal, and R. . . . . cical Devices 510(x) Number .
*Prescription Use*
{7}------------------------------------------------
The following tables provide the intended clinical use for the MyLab15/20 probes in
ternation of the bounters: The forlowings
combination with the system:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | P[2] | P[3], N[4] |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | P[2] | P[3], N[4] |
| Small Organ (specify) [1] | | P | P | P | | P | P | | P[2] | P[3], N[4] |
| Neonatal Cephalic | | P | P | P | | P | P | | P[2] | P[3], N[4] |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | | P[2] | P[3], N[4] |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | P[2] | P[3], N[4] |
| Musculo-skeletal Superficial | | P | P | P | | P | P | | P[2] | P[3], N[4] |
#### Transducer: LA523
Other (specify) other (specify)_______________________________________________________________________________________________________________________________________________________________
Additional Comments:
nal Comments:
[1] Small organs include Thyroid, Breast and Testicles.
[1] Small organs include Thyroid, Breast and Testicles.
[1] Small organs include Thyrold, Breast and Testeres:
[2] Applicable combined modes: B+M+PW+CFM+Amplitude Doppler
[2] Applicable combined movies: (TED
[2] Applicable comotios Imaging (TEI)
[3] Tissue Enhancement Imaging (TEI)
[4] 3D Imaging
Frescription Use
Narryl Brogdon
(Division Sign Off) (Division Sign-Olf)
Division of Reproductive, Abdominal, Division in Janu Most Devices 510(k, mumber ---
14
{8}------------------------------------------------
#### Transducer: LA424
| | | | | | | Mode of Operation | | | | |
|----------------------------------|---|---|---|-----|-----|-------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | | N | N | | N[2] | N[3], N[4] |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | | N[2] | N[3], N[4] |
| Small Organ (specify) [1] | | N | N | N | | N | N | | N[2] | N[3], N[4] |
| Neonatal Cephalic | | N | N | N | | N | N | | N[2] | N[3], N[4] |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | | N[2] | N[3], N[4] |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | N | N | | N | N | | N[2] | N[3], N[4] |
| Musculo-skeletal Superficial | | N | N | N | | N | N | | N[2] | N[3], N[4] |
| Other (specify) | | | | | | | | | | |
N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:
[1] Small organs include Thyroid, Breast and Testicles.
[ [ ] Small organs melude Thyton, Breast and Testation
[2] Applicable combined modes: B+M+PW+CW+CFM+Amplitude Doppler
[2] Applicable combined modes: B+M+PW+CW+CFM+Amplitude D
[2] Tissue Enhancement Imaging (TEI)
[4] 3D Imaging
ear [171
Nancy Hogdon
(Division Sign-Off) Sonon of Reproductive, Abdominal, : Deyings
{9}------------------------------------------------
## Transducer: CA421P
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | P[2], N[3] |
| Fetal | | P | P | P | | P | P | | P[1] | |
| Abdominal | | P | P | P | | P | P | | P[1] | P[2], N[3] |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | P[1] | P[2], N[3] |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
oner (speny)
N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:
onal Comments:
[1] Applicable combined modes: B+M+PW+CFM+Amplitude Doppler.
[1] Applicable combined Instaina (TEU
- [1] Applicable enhancement Imaging (TEI)
- (3) 3D Imaging
Nancy C. Hodgson
(Division Sigo-Off) Division of Reproductive, Abdominal, and Radiological Devices ち (((x) Number _
{10}------------------------------------------------
#### Transducer: CA421
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | P[1] | P[2], N[3] |
| Abdominal | | P | P | P | | P | P | | P[1] | P[2], N[3] |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | P[1] | P[2], N[3] |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
outer(spen);
N=new indication; P=previously cleared by FDA; E= added under Appendix E
Additional Comments:
nal Comments:
[1] Applicable combined modes: B+M+PW+CFM+Amplitude Doppler.
[1] Applicable combined modes: «TEV
[1] AppliceShancement Imaging (TEI)
[3] 3D Imaging
Nency C. hoodon
(Division Sign-Off)
Division of Reproductive, Abdominal, read Nogatur Devices 5 ! O(k) Number ______________________________________________________________________________________________________________________________________________________________ 315 5
17
{11}------------------------------------------------
#### Transducer: CA621
| | | Mode of Operation | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | N | N | N | | | N | N | | N[1] | N[2], N[3] |
| Abdominal | N | N | N | | | N | N | | N[1] | N[2], N[3] |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | N | N | N | | | N | N | | N[1] | N[2], N[3] |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:
nal Comments.
[1] Applicable combined modes: B+M+PW+CFM+Amplitude Doppler.
- [2] Tissue Enhancement Imaging (TEI)
- [3] 3D Imaging
Nancyc Brogdon
(Division Size (Nif) (Division Siznation of Sopen ructive, Abdominal,
Division of Sopen ructive, Alodominal, Division of the Status and Radiological Devices and Radiological Devices S and hatiloog
510(k) Number ---------------------------------------------------------------------------------------------------------------------------------------------------
{12}------------------------------------------------
## Transducer: BC432P
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | N | N | N | N | | N | N | | N[1] | N[2], N[3],<br>N[4] |
| Abdominal | N | N | N | N | | N | N | | N[1] | N[2], N[3],<br>N[4] |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | N | N | N | N | | N | N | | N[1] | N[2], N[3],<br>N[4] |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
Other (speny)
N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:
onal Comments:
[1] Applicable combined modes: B+M+PW+CFM+Amplitude Doppler. [
- [1] Appheable comment Imaging (TEI)
- [3] 3D Imaging
- (4) 4D Imaging
Na
(Digitalia: ியுள்ள an: 1 .. 15 - 11 - 11 - 11 -
ff)
reproductive, Abdominal,
al Devices
K053154
{13}------------------------------------------------
#### Transducer: EC123
| Mode of Operation | | | | | | | | | | |
|-----------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | P[1] | P[2], N[3] |
| Transvaginal | | P | P | P | | P | P | | P[1] | P[2], N[3] |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculoskeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N=new indication; P=previously cleared by FDA; E= added under Appendix E
Additional Comments:
Additional Comments:
[1] Applicable combined modes: B+M+PW+CFM+Amplitude Doppler.
[2] Tissue Enhancement Imaging (TEI)
[3] 3D Imaging
Nancy C. Brogdon
(Division Sign L)" ifive, Abdominal. Division of Reer and Radiological - levices 510(k) Number ____
{14}------------------------------------------------
#### Transducer: E8-5 R10
| | Mode of Operation | | | | | | | | | |
|-----------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | P[1] | P[2], N[3] |
| Transvaginal | | P | P | P | | P | P | | P[1] | P[2], N[3] |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculoskeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N=new indication; P=previously cleared by FDA; E= added under Appendix E
Additional Comments:
Additional Contined modes: B+M+PW+CFM+Amplitude Doppler.
[1] Applicable combined modes: (TED
[2] Tissue Enhancement Imaging (TEI)
[3] 3D Imaging
R 100
\$\checkmark\$
Nancy C. Hogdon
(Division Sign ાની Division of Reporductive, Abdomin and Radinlogica: Devices
510(k) Number _______________________________________________________________________________________________________________________________________
