ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER
Device Facts
| Record ID | K102138 |
|---|---|
| Device Name | ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER |
| Applicant | Edan Instruments, Inc. |
| Product Code | MAA · Obstetrics/Gynecology |
| Decision Date | Oct 28, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.2660 |
| Device Class | Class 2 |
Intended Use
The Ultrasonic TableTop Doppler is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices. The 2 MHz and/or 3 MHz probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability following patient trauma. The 4 MHz, 5 MHz and/or 8 MHz vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.
Device Story
Ultrasonic TableTop Doppler (models SD5, SD6) is a diagnostic ultrasound system for fetal heart rate monitoring and peripheral vascular blood flow detection. Input: ultrasonic signals from CW probes (2, 3, 4, 5, 8 MHz). Operation: device processes reflected ultrasound waves to output fetal heart sounds (with 240-second record/playback) and blood flow signals. Used in hospitals, clinics, and private offices by healthcare professionals. SD6 supports infrared communication. Power: Ni-MH battery for main unit; Li-ion battery for SD6 probe. Output: audible heart sounds and blood flow signals; visual indicators. Healthcare providers use output to assess fetal status or peripheral vascular health, aiding clinical decisions regarding pregnancy management or vascular disease diagnosis.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Continuous Wave (CW) Doppler ultrasound system. Probes: 2, 3, 4, 5, 8 MHz. Power: Ni-MH battery (main unit), Li-ion battery (SD6 probe). Connectivity: Infrared (SD6). Form factor: Tabletop. Operation: Fetal heart rate and blood flow detection. Sterilization: Not specified.
Indications for Use
Indicated for detection of fetal heart rate (2/3 MHz probes) from early gestation through delivery, assessment of fetal well-being, and verification of fetal viability post-trauma. Indicated for detection of blood flow in veins and arteries (4/5/8 MHz probes) to assist in diagnosis of peripheral vascular disease. Intended for use by healthcare professionals (nurses, midwives, technicians, PAs) under physician prescription.
Regulatory Classification
Identification
A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.
Predicate Devices
- IMEXDOP CT+ (K942441)
- Sonotrax series pocket Doppler (K080087)
- Ultrasonic TableTop Doppler (K092997)
Related Devices
- K092997 — ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 · Edan Instruments, Inc. · Nov 10, 2009
- K153475 — SD5 & SD6 Ultrasonic Tabletop Doppler · Edan Instruments, Inc. · Jan 29, 2016
- K112529 — TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER · Advanced Instrumentations, Inc. · Oct 27, 2011
- K090499 — LIFEDOP MODEL, L350R · Summit Doppler Systems, Inc. · Mar 31, 2009
- K080087 — SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR · Edan Instruments, Inc. · Mar 11, 2008
Submission Summary (Full Text)
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Section 1
## 510(k) Summary of Safety and Effectiveness
OCT 2 8 2010
This summary of 510k safety and effectiveness is being submitted in according with 21CFR part 807.92
| Submitter: | Edan Instruments, Inc<br>3/F - B, Nanshan Medical<br>Equipments Park, Nanhai Rd 1019#,<br>shekou, Nanshan Shenzhen,<br>518067 P.R. China<br>Tel: 86-755-26882220<br>Fax:86-755-26882223<br>Contact person: Yue Qiuhong |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official correspondent: | William Stern<br>Multigon Industries, Inc..<br>1 Odell Plaza<br>Yonkers, N.Y. 10701<br>Phone: 914 376 5200 X27<br>Fax: 914 376 6111 |
| Date of Preparation: | 2010-7-20 |
| Proprietary Name: | Ultrasonic TableTop Doppler (Models SD5, SD6) |
| Classification Name: | 21 CFR 884.2660 Fetal ultrasonic monitor and accessories<br>21 CFR 884.2660 Ultrasound Blood Flow Monitor |
| Product code: | MAA/JAF |
Predicate Devices:
| Predicate devices | IMEXDOP CT+ | Sonotrax series pocket<br>Doppler | Ultrasonic TableTop<br>Doppler |
|-------------------|------------------------------|-----------------------------------|--------------------------------|
| Manufacturer | Imex Medical<br>Systems, Inc | Edan Instruments, Inc | Edan Instruments,<br>Inc |
| K # | K942441 | K080087 | K092997 |
Ultrasonic TableTop Doppler provides the following primary features: Device Description:
- · Basic parameters: FHR, blood flow
- · 240 seconds fetal heart sound record and playback
- · Infrared communication(for SD6 only)
- Ni-MH battery for 20 hours continuous working of main unit
- · Li-ion battery for 2.5 hours continuous working of SD6 probe
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's emblem, which is a stylized representation of a human figure embracing another person. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Yue Qiuhong Certification Engineer Edan Instruments. Inc. 3/F - B, Nanshan Medical Equipment Park Shenzhen, Guangdong 518067 CHINA
OCT 2 8 2010
Re: K102138
Trade/Device Name: Ultrasonic TableTop Doppler (models SD5 and SD6) Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: MAA and JAF Dated: September 29, 2010 Received: October 4, 2010
Dear Ms. Qiuhong:
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 Ultrasonic TableTop Doppler (models SD5 and SD6), as described in your premarket notification:
Transducer Model Number
5MHz CW Vascular Probe-model: SD5 4MHz CW vascular probe-model SD5 8MHz CW vascular probe-model SD5 5MHz CW wireless vascular probe-model: SD6 4MHz CW wireless vascular probe-model: SD6 8MHz CW wireless vascular probe-model SD6
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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 895. 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Jana Delfino at (301) 796-6503.
Sincerely yours,
Signature
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
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# 1741
Ultrasonic TableTop Doppler Traditional 510K Submission
### Indication for Use
510(k) Number (if known):
OCT 2 8 2010
Section
Device Name: Ultrasonic TableTop Doppler (models SD5 and SD6)
The Ultrasonic TableTop Doppler is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices.
The 2 MHz and/or 3 MHz probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability following patient trauma.
The 4 MHz, 5 MHz and/or 8 MHz vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.
× Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C)
#### Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K102138
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| | | | Ultrasonic Table Top Doppler 510K Submission | | | | | | | | | | | | | | |
| | | | | | | | | | | | Diagnostic Ultrasound indications for Use For | | | | | | |
| | | | | | | | | | | | ill out one form for each ultrasound system and each transducer<br>5MHz CW vascular probe- model: SD5<br>imaging or fluid flow analysis of the | | | | | | |
| | | | | Clinical Application | Intended use : Diagnostic ultrasound | | HAM | PWDF | CWD | Color | Mode Uperation<br>Amplitude | Color | numan body as follow<br>Combine | other | | | |
| | | | Ophthalmic Ophthalmic | | | | | | | Doppler | Doppler | Velocity<br>11008 833 6 | Specify | Specify | | | |
| | | | Abdominal Abdominal<br>Intraoperative(specify) I | - Retal | | 1888 118 13 | | | | | | | | | | | |
| | | | Intraoperative Neurological<br>Pediatric Pediatric Childer Link | Small Organ(specify) | | | ン | | | | | | | | | | |
| | | | Cardiac Cardiac Cardiac | Neonatal Cephalic . | | ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ | | | | | | | | | | | |
| | | | | Transesophageal Transes<br>Transrectal<br>Transvaginal Land Call | | | | | | | | | | | | | |
| | | | Peripherain Vascular | Transurethral The St<br>Intravascular | | ar Pri | | | . In Bissis - | | | | | | | | |
| | | | Conventional Conventional | Laparoscopic I<br>Musculo-skeletal | | 11:3 | ﺍﻟﻤﻮﺿﻮﻉ ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ | | | | | | | | | | |
| | | | Musculo-skeletal Superficial | | Other | | | | | | | | | | | | |
| | | | ، ﻭﻳﺘﻢ ﻣ | | | 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 | | Contraction Comments of | | | Nenew indication; P-previously cleared by FDA e-ADDED UNDER appendix B<br>Additional Comments: The above is a 5MHz CW transducer for the blood flow detection,<br>ົນ ແລະ ພິສາຫະກຳລັງ ແລະ ສະຫຼຸບສາຫະກຳ | | . | | | | |
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#### Ultrasonic Table Top Doppler 510K Submission,
## . . Diagnostic Ultrasound indications for Use Form
Fill out one form for each ultrasound system and each transducer. a problem 1 1 4MHz CW vascular probe- model: SD5
| Clinical Application | A | B | M | PWD | CWD | Mode Operation | | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
|------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | Color<br>Doppler | Amplitude<br>Doppler | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ(specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheraln Vascular | | | | | N | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other | | | | | | | | | | |
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. :
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Additional Comments: The above is a 4MHz CW transducer for the blood flow detection,
Pattern . . . . . . . . . . . . . . . . . . . . . . . . .
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510K
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:
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE I FNEEDED CONCURRENCE OF cdrts, Office of Device Evaluation (ODE)
: 上海
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
{6}------------------------------------------------
#### Ultrasonic Table Top Doppler 510K Submission
新闻网
# . Diagnostic Ultrasound indications for Use Form
Fill out one form for each ultrasound system and each transducer. a problema a problem 8MHz CW vascular probe-model: SD5 - - 1 percent
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| Clinical Application | | | | | | | Mode Operation | | | |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|-------|------|-------|----------------|-----------------------|----------|--|
| | | র ক | MB | CHWDE | SEWO | Color | Amplitude | Color<br>1988 2021 35 | Combiner | |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative(specify) | | | | | | | | | | |
| Intraoperative Neurological | . Salaman | | | | | | | | | |
| Pediatrica | | | | | | | | | | |
| Small Organ (specify) | ? - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - | ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Cardiac" """ | - રહ્યું | 23 : 11 : 14 | 12, 2017 | | | | | | | |
| Transesophageal | ・ア | | | | | | | | | |
| Transrectal Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral + + ) | | | : - | | | | | | | |
| Intravascular mascular | | ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮ | | | | | | | | |
| Peripheraln Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Convention | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| . But Burner of Other Barrer | | | | | | | | | | |
N-liew indication, Tr-previously cleared by FDA, 6-ADDED UNDER appendix B
Additional Comments:
1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
,
-30 11 2 (Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
的感情 :
510K
PLEASE DO NOT WRITE BEFORETHIS LINE CONTINUE ON ANOTHER PAGE (FNEEDED CONCURRENCE OF carb, Office of Device Evaluation (ODE)
{7}------------------------------------------------
Ultrasonic Table Top Doppler 510K Submission
## ... Diagnostic Ultrasound indications for Use Rorm
# Tillyoutone formifor: each ultrasound: system: and, each transducer.
#5MHz, CW, w/reless vascular, probe, model: SD6
... Intended we : Diegosticultiasond imaging, of fuildflo
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| Clinical Application | Mode Operation | | | | | | | | | |
|------------------------------|----------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | 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 | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheraln Vascular | | | | | | | | | N | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other | | | | | | | | | | |
PLEASE DO NOT WRITE BELOW THIS TINUE ON ANOTHER PAGE I FINE CONCURRENCE OF carb, Office of Device Evaluation (ODE)
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Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
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510K K102138
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ය පිහිටුද්ද
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ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
# Fill out one for miror each ultrasound system and each transducer.
AMHz: CW wireless vascular probe-model: SD66
Intended,use: Diggootic illusiond imaging or fuid how analysis
ended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| Clinical Application | A | B | M | PWD | CWD | Mode Operation | | | Other (specify) |
|------------------------------|---|---|---|-----|-----|----------------|-------------------|------------------------|-----------------|
| | | | | | | Color Doppler | Amplitude Doppler | Color Velocity Imaging | |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intraoperative(specify) | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ(specify) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Cardiac | | | | | | | | | |
| Transesophageal | | | | | | | | | |
| Transrectal | | | | | | | | | |
| Transvaginal | | | | | | | | | |
| Transurethral | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Peripheraln Vascular | | | | | N | | | | |
| Laparoscopic | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | |
| Conventional | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | |
| Other | | | | | | | | | |
N=new indication; P=previously cleared by FDA; e=ADDED UNDER appendix E
Additional Comments: The above is a 4MHz CW transducer for the blood flow detection.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
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(Division Sign-Off)
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10213
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