(90 days)
Not Found
No
The summary describes a standard Doppler device for detecting heart rate and blood flow, with no mention of AI, ML, or related technologies in the intended use, device description, or performance studies sections.
No
This device is for detection and monitoring (fetal heart rate, blood flow) and does not describe any therapeutic function or intervention.
Yes
This device is used for "detection of fetal heart rate," "general indication of fetal well being," "verify fetal heart viability," and "detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease." These functions explicitly refer to the identification or measurement of medical conditions or physiological states.
No
The device description explicitly mentions hardware components such as probes, batteries, and infrared communication, indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device uses ultrasound to detect physiological signals (fetal heart rate and blood flow) directly from the patient's body. It does not analyze samples taken from the body.
The device's function is to use external ultrasound technology to listen to and measure internal physiological processes, which falls under the category of medical devices but not specifically in vitro diagnostic devices.
N/A
Intended Use / Indications for 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.
Prescription Use (21 CFR Part 801 Subpart D)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Product codes (comma separated list FDA assigned to the subject device)
MAA, JAF
Device Description
Ultrasonic TableTop Doppler provides the following primary features:
- 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal heart, veins, arteries.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.2660 Fetal ultrasonic monitor and accessories.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
3/F - B, Nanshan Medical
Equipments Park, Nanhai Rd 1019#,
shekou, Nanshan Shenzhen,
518067 P.R. China
Tel: 86-755-26882220
Fax:86-755-26882223
Contact person: Yue Qiuhong |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official correspondent: | William Stern
Multigon Industries, Inc..
1 Odell Plaza
Yonkers, N.Y. 10701
Phone: 914 376 5200 X27
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
21 CFR 884.2660 Ultrasound Blood Flow Monitor |
| Product code: | MAA/JAF |
Predicate Devices:
| Predicate devices | IMEXDOP CT+ | Sonotrax series pocket
Doppler | Ultrasonic TableTop
Doppler |
|-------------------|------------------------------|-----------------------------------|--------------------------------|
| Manufacturer | Imex Medical
Systems, Inc | Edan Instruments, Inc | Edan Instruments,
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
1
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
2
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)
3
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
4
| . | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ultrasonic Table Top Doppler 510K Submission | |||||||||||||||||
| Diagnostic Ultrasound indications for Use For | |||||||||||||||||
| ill out one form for each ultrasound system and each transducer | |||||||||||||||||
| 5MHz CW vascular probe- model: SD5 | |||||||||||||||||
| imaging or fluid flow analysis of the | |||||||||||||||||
| Clinical Application | Intended use : Diagnostic ultrasound | HAM | PWDF | CWD | Color | Mode Uperation | |||||||||||
| Amplitude | Color | numan body as follow | |||||||||||||||
| Combine | other | ||||||||||||||||
| Ophthalmic Ophthalmic | Doppler | Doppler | Velocity | ||||||||||||||
| 11008 833 6 | Specify | Specify | |||||||||||||||
| Abdominal Abdominal | |||||||||||||||||
| Intraoperative(specify) I | - Retal | 1888 118 13 | |||||||||||||||
| Intraoperative Neurological | |||||||||||||||||
| 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 | |||||||||||||||||
| Transrectal | |||||||||||||||||
| Transvaginal Land Call | |||||||||||||||||
| Peripherain Vascular | Transurethral The St | ||||||||||||||||
| Intravascular | ar Pri | . In Bissis - | |||||||||||||||
| Conventional Conventional | Laparoscopic I | ||||||||||||||||
| 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 | ||||||||||||||
| Additional Comments: The above is a 5MHz CW transducer for the blood flow detection, | |||||||||||||||||
| ົນ ແລະ ພິສາຫະກຳລັງ ແລະ ສະຫຼຸບສາຫະກຳ | . | ||||||||||||||||
| ্রে প্রায় | PERSE PERSONAL CONCURRENCE OF carb, Office of Device Evaluation (ODE I FNEEDED AND AND A | नामुळ | ്ചിക് | 19 | |||||||||||||
| ి ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ఆరోగ్య కేంద్రం మూలాలు సం | ्रा | ्री के साथ की में बाद में कि में बाद में कि में कि में कि में कि में कि में कि में कि में कि में कि में कि में कि में कि में कि में कि में कि में कि में कि में कि में कि में | ាញ់ ប្រើ ប្រ | 的。 | ్రామం | 사용 | ,在台 | ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤ | ﺍﻟﻤﻮﺿﻮﻉ | ||||||||
| : | 월부 | 一 | 哪 | - | : | , | ្ម | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | : | ్లో | |||||||
| 我们 | : 上海 | ் இந் | - 헬륨- | : | ﺍﻟﻤﺴﺘﻮﻯ | :2017 | : | 德拉 | ్లో ప్రా | na | ,可能产 | ינוני | "我的 | ்கு | |||
| ्रक | ्बद्धाः | : | ्म | 网站 | ా చేస్తే. | ు | : | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ੀ | ||||||||
| 이가 · | ្រព្រៃក | , | 的电视 | (Division Sign-Off) Office of In Vitro Diagnostic Devices Office of In Vitro Diagnostic Device Evaluation and Safety | 1 - 1 | 1 (186 | : * :: | ||||||||||
| - | : | 100 | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | A TOK | 0 d | 17 | ్లా | 能 | ं क | ്ല്യ പ | 11:22:2 | ు | |||||
| क्रम के | :国 | : | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | 网站 | ी को | ,被 | : 我 | ्क | 대한 | 参考文献 | - 2017 | - 德 | |||||
| appille | : | : | ్రామంలో | ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ | ్రాల్లో | : _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ | 中 | ుం | : | े के | ्री क | i-Ali | सम्बद्ध | ్రామె | ు శ్రీ | ||
| , | ிக | , | - - - | යේ | 11:2 | 1000 |
5
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
Velocity
Imaging | Combined
(specify) | Other
(specify) |
|------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | Color
Doppler | Amplitude
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 | | | | | | | | | | |
ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤ
ੋ ਸ਼ਹਿਰ
. :
ាន់នៅជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជា
ਾ ਸੀ। ਉਸਦੇ ਸ
ी
Additional Comments: The above is a 4MHz CW transducer for the blood flow detection,
Pattern . . . . . . . . . . . . . . . . . . . . . . . . .
13
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
510K
් පිහිටි විද්යා දින දිස්ත්රියා දින අධික්රියා විද්යා පිහිටු බව විසින් විසින් වි
:
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
111 18
- 1938
12:42
· 국민(80), ·
1000
ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴ
| Clinical Application | Mode Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| র ক | MB | CHWDE | SEWO | Color | Amplitude | Color | ||||
| 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 | ||||||||||
| 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 | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (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)
s
.....
sipal
| পরি:
- 11:4
16:31:5
్రప్రదేశ్
ं क
distri
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(월
ा
能
ੀ ਕਿ
ાં વિસ્ત
:
:00
:
:
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
. 浏览:
510K K102138
,
:
ಿ ಸಾ
一般二十二次
:
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
3 - 1 - 1 - 1988
යා බො
ូឡើង
8
Ultrasonic TableTop Doppler 510K Submission
- 199
制品
期
ी हिं
一
- Alla
:
:
ેંકુટે મ
:
: : : :
服务
:
| 注
147
్రామం
小游
ាន់
510K
:河南省
om "i
ﻟﻤﺆﺳﺴﺎ
ਾ ਸ
.
。 参考
:
::
..............................................................................................................................................................................
્યા હ
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
1
18
्
新闻
ുന്നു.
து இருக்
: 上一篇:
துக
:
ﺍﻟﻤﺴﺎﻋﺪﺓ
:
्री में कि
ানী প্রকৃতি প্রক
-
http://
-
中
:
:
ﻟﻠﻘﻀﺎﺀ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ
... ...
..
ය පිහිටුද්ද
:
:
.
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
CONCURRENCE OF cdrh, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
10213
4
्
人
9
| Ultrasonic Table Top Doppler 51,0K Submission | ||
|---|---|---|
- 2
: 上一篇:
াকিং
球比
Diagnostic Ultrasound indications for Use Form
समी में बिहारियां
વસાય ખેતી
- 高
: :
**
. (8)
: :
. "Fill out one form for each ultrasound system and each transducer. 8MHz CW wireless vascular probe- model: SD6
Intended use : Diagnostic ultrasound imaging or fluid flow and your as follows
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 Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (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 |
N=new indication; P=previously cleared by FDA; σ=ADDED UNDER appendix E
Additional Comments: The above is a 8MHz CW transducer for the blood flow detection.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE I FNEEDED CONCURRENCE OF edrice of Device Evaluation (ODE)
.
:
,我
(
(Division Sign-Off)
: 2018-0 Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K1622438
机
的
б
.