SIGMA 5000 SERIES, IMAGIC
Device Facts
| Record ID | K061437 |
|---|---|
| Device Name | SIGMA 5000 SERIES, IMAGIC |
| Applicant | Kontron Medical Systems Sas |
| Product Code | IYN · Radiology |
| Decision Date | Jun 14, 2006 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Indications for Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound investigations: Imaging (B-mode), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Color Flow Mapping (CFM) and Color Time motion (CM mode).
Device Story
Sigma 5000 series, Imagic is a diagnostic ultrasound imaging system. It processes acoustic signals received via transducers to produce real-time images and flow analysis. Modes include B-mode, M-mode, PW/CW Doppler, Color Flow Mapping, and Color Time motion. Used in clinical settings by healthcare professionals for diagnostic examinations. Output is displayed for clinician interpretation to support clinical decision-making and patient diagnosis. Benefits include non-invasive visualization of internal structures and blood flow.
Clinical Evidence
Bench testing only. The device was evaluated for acoustic output and thermal safety, conforming to applicable medical device safety standards. No clinical tests were required as the device utilizes the same technology and principles as existing, legally marketed devices.
Technological Characteristics
Diagnostic ultrasound system utilizing pulsed echo and pulsed Doppler imaging. Transducers include phased array, convex array, and pencil probes. Connectivity and software architecture are consistent with previously cleared Sigma 5000 series devices. Conforms to 21 CFR 820 and ISO 13485:2003 standards. Safety verified through independent evaluation of acoustic output and electrical/mechanical safety.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in clinical applications including Fetal, Abdominal, Pediatric, Small organs (Thyroid, Breast, Testicle), Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), and Adult Cephalic (Transcranial).
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
- Kontron Medical Sigma 110/330 (K002239)
Reference Devices
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for Kontron Medical. The logo features a stylized "K" on the left, with vertical lines resembling a ruler. To the right of the "K" is the word "KONTRON" in bold, sans-serif font, and below that is the word "MEDICAL" in a thinner, sans-serif font.
# Summary of Safety and Effectiveness
Prepared in accordance with 21 CFR Part 807.92(c)
| | K061437 | JUN 1 4 2006 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 1. Submitter Information | | |
| a. Submitter: | Kontron Medical SAS<br>52, rue Pierre Curie<br>78373 Plaisir, Yveline<br>France | |
| b. Contact Person: | Mr. Larry Walker<br>Fukuda Denshi USA INC.<br>17725 N.E. 65th Street Bldg. C<br>Redmond, WA 98052-4911<br>Phone:800-365-6668<br>Fax: 425-869-2018 | |
| c. Date Prepared: | 07 February 2006 | |
| 2. Name of device | | |
| a. Trade name: | Sigma 5000 series, Imagic | |
| b. Common name: | Medical Diagnostic Ultrasound Imaging System and transduc-<br>ers | |
| c. Classification name: | Ultrasonic Pulsed Doppler Imaging System 21 CFR 892.1550<br>90-IYN<br>Ultrasonic Pulsed Echo Imaging System 21 CFR 892.1560<br>90-IYO<br>Diagnostic Ultrasonic Transducer 21 CFR 892.1570 90-ITX | |
3. Equivalent Legally-Marketed Devices:
Kontron Medical Sigma 110/330, K002239
The technological characteristics of the predicate device are the same as those of the new device.
### 4. Description
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This submission will add a Adult Cephalic (Adult Transcranial) indication for use to the Sigma 5000 series, Imagic, which was already cleared with the following diagnostic ultrasound investigations: Imaging (B-mode), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Color Flow Mapping (CFM) and Color Time motion (CM mode), see K050099 and K053084.
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5. Intended use
Image /page/1/Picture/1 description: The image shows the logo for Kontron Medical. The logo consists of a stylized letter "K" on the left, followed by the word "KONTRON" in bold, sans-serif font. Below "KONTRON" is the word "MEDICAL" in a thinner, sans-serif font. The logo is black and white.
## 1161437
Diagnostic ultrasound investigations: Imaging (B-mode), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Color Flow Mapping (CFM) and Color Time motion (CM mode).
- 6. Performance Data
- a. Non-clinical tests: The device has been evaluated for acoustic output and thermal, and has been found conform with applicable medical device safety standards. Cleared patient contact materials, electrical and mechanical safety are unchanged.
- b. Clinical tests: Since the Sigma 5000 series Imagic uses the same technology and principles as existing devices, clinical tests are not required.
- c. Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO13485:2003 quality system standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore it is the opinion of Kontron Medical that the Sigma 5000 series Imagic is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
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Image /page/2/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" around the perimeter. Inside the circle is a stylized representation of three human figures, with their arms raised and connected, forming a symbol that resembles a family or community.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 4 2006
Kontron Medical S.A.S. % Mr Robert Mosenkis President CITECH 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298
Re: K061437
Trade Name: Sigma 5000 series, Imagic 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: May 23, 2006 Received: May 24, 2006
Dear Mr. Mosenkis:
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 Sigma 5000 series, Imagic, as described in your premarket notification:
Image /page/2/Picture/11 description: The image shows a circular seal with the letters "FDA" in the center. The letters are in a bold, sans-serif font. Above the letters, there is some text that is difficult to read due to the image quality. Below the letters, there is the word "Centennial" in a cursive font. The seal has a dotted border.
ometing Public Health
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#### Transducer Model Number
| 2-4 PA |
|-----------|
| 2-5 CA |
| 3-8 PA |
| 3-8 TEM |
| 4-9EC |
| 5-12 LA |
| 5-12 L50 |
| 2 MHz Pen |
| 8 MHz Pen |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
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This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Ralph Shuping. Sc.D at (301) 594-1212.
Sincerely yours,
Danielle Lyons
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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1 - 11:22:21 - 1
Image /page/5/Picture/1 description: The image shows the logo for Kontron Medical. The logo features a stylized letter "K" on the left, with the word "KONTRON" in bold, sans-serif font to the right of the "K". Below "KONTRON" is the word "MEDICAL" in a thinner, sans-serif font. The logo is black and white.
K061437
## Diagnostic Ultrasound Indications for Use Form
### System: Sigma 5000 series, Imagic
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|-----------------------------------|-------------------|---|---|---------|---------|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PW<br>D | CW<br>D | 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 | | P | |
| Abdominal | P | P | P | P | | P | P | | P | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neuro-<br>logical | | | | | | | | | | |
| Pediatric | P | P | P | P | | P | P | | P | |
| Small organs (specify) | P | P | P | P | | P | P | | P | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | N | N | N | N | N | N | N | | N | |
| Cardiac | P | P | P | P | P | P | P | | P | |
| Transesophageal | P | P | P | P | P | P | P | | P | |
| Transrectal | P | P | P | P | | P | P | | P | |
| Transvaginal | P | P | P | P | | P | P | | P | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | |
| Laparascopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | P | P | P | P | | P | P | | P | |
| Musculo-skeletal Super-<br>ficial | P | P | P | P | | P | P | | P | |
| Other (specify) | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments:
- · Small organs: Thyroid, Breast, Testicle
- Combined modes: B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD
.............................................................................................................................................................................. ..............................................................................................................................................................................
..............................................................................................................................................................................
Concurrence of CDRH, Office of Device Evaluation (ODE),
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal,
Radiological Devices
Number K0614-
Sigma 5000 series, IMAGIC : Summary of Safety and Effectiveness
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the logo for Kontron Medical. The logo consists of a stylized letter K on the left, with the word "KONTRON" in bold, black letters above the word "MEDICAL" in a thinner, outlined font. The letter K on the left has a dot in the middle.
\$\qquad \underset{}{\text{tio}}6\underset{}{\text{ }}1437\underset{}{\text{ }}
Ultrasound Indications for Use
Diagnostic Ultrasound In for Use Form
System: Sigma 5000 series, Imagic
Transducer: 2-4 PA
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|-----------------------------------|-------------------|---|---|---------|---------|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PW<br>D | CW<br>D | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neuro-<br>logical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small organs (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | N | N | N | N | N | N | N | | N | |
| Cardiac | P | P | P | P | P | P | P | | P | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | N | N | N | N | N | N | N | | N | |
| Laparascopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Super-<br>ficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments:
• Combined modes: B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… ..............................................................................................................................................................................
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(ODE)
(Division Sign-Off)
Division of Reproductive, « · Radiological Devices and a Number _
Sigma 5000 series, IMAGIC : Summary of Safety and Effectiveness
. . .
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image shows the logo for Kontron Medical. The logo consists of a stylized "K" symbol on the left, followed by the word "KONTRON" in bold, uppercase letters. Below "KONTRON" is the word "MEDICAL" in a thinner, uppercase font. The "K" symbol is a geometric design with vertical lines and a central dot.
# Kob1437
Diagnostic Ultrasound Indications for Use Form
System: Sigma 5000 series, Imagic
Transducer: 2-5 CA
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|-----------------------------------|-------------------|---|---|---------|---------|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PW<br>D | CW<br>D | 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 | |
| Abdominal | | P | P | P | | P | P | | P | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neuro-<br>logical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small organs (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | | N | |
| Laparascopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Super-<br>ficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments:
· Combined modes: B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… ..............................................................................................................................................................................
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
ion (ODE)
David K. Ayres
Division Sign-C Division of Reproductive. Abdomi and Radiological Devices 510(k) Number
Sigma 5000 series, IMAGIC : Summary of Safety and Effectiveness
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Image /page/8/Picture/1 description: The image shows the logo for Kontron Medical. The logo consists of a stylized letter "K" on the left, with a series of vertical lines and a dot incorporated into its design. To the right of the "K" is the word "KONTRON" in bold, sans-serif font, stacked above the word "MEDICAL" in a thinner, outlined font.
nd Indications for Use Form Diagnostic
System: Sigma 5000 series, Imagic
Transducer: 3-8 PA
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|-----------------------------------|-------------------|---|---|---------|---------|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PW<br>D | CW<br>D | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neuro-<br>logical | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P | |
| Small organs (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Super-<br>ficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
· Combined modes: B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD
…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Daniela Lynn
(Division Sign-Off)
Division of Reproductive, Abdominal,
Radiological Devices
Sigma 5000 series, IMAGIC : Summary of Safety and Effectiveness
Page 6
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. The same the consider of the
Image /page/9/Picture/1 description: The image shows the logo for Kontron Medical. The logo consists of a stylized letter "K" on the left, followed by the word "KONTRON" in bold, uppercase letters. Below "KONTRON" is the word "MEDICAL" in a thinner, uppercase font.
K6 1437
Diagnostic Ult Indications for Use Form
System: Sigma 5000 series, Imagic
Transducer: 3-8 TEM
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|-----------------------------------|-------------------|---|---|---------|---------|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PW<br>D | CW<br>D | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neuro-<br>logical | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small organs (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P | | |
| Transesophageal | | P | P | P | P | P | P | | P | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparascopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal Super-<br>ficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments:
• Combined modes: B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD
........................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................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