FLYING DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K083877 |
|---|---|
| Device Name | FLYING DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Neusoft Medical Systems Co., Ltd. |
| Product Code | ITX · Radiology |
| Decision Date | Jan 13, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1570 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: [Applications listed in tables include: Ophthalmic, Fetal/Obstetric, Abdominal, Intra-operative (vascular, epicardial, neuro), Pediatric, Small Organ (thyroid, scrotum, prostate, breast), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Gynecological, Cardiac (Adult, Pediatric), Peripheral vessel, Musculo-skel (conventional, superficial). Modes include: B, M, Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Combined (Duplex, Triplex), and others including Color Power Angio, 3D, Panoramic, Harmonics, Directional Angio Imaging, Tissue Doppler Imaging.]
Device Story
FLYING Diagnostic Ultrasound System; console-based system with display and multiple transducers (L12-3, L12-5 50, 15-6L, S4-2, S8, C5-2, C8-4V, E6509, D5009V). System generates electronic voltage pulses sent to transducers; piezo-electric arrays convert pulses into ultrasonic pressure waves. Waves reflect off body tissues; transducers convert echoes back to electrical signals. System processes signals to generate B-mode, M-mode, Doppler (PWD, CWD, Color, Tissue), 3D, and harmonic images. Used in clinical settings by healthcare professionals for diagnostic imaging and fluid flow analysis. Output displayed on screen for clinical interpretation to aid in diagnosis and patient management.
Clinical Evidence
Bench testing only. No clinical data provided. Substantial equivalence is based on technological characteristics, performance testing, and compliance with safety standards for diagnostic ultrasound systems.
Technological Characteristics
System console with power supply and electronic circuitry; piezo-electric transducer arrays. Modes: B, M, PWD, CWD, Color Doppler, 3D, Panoramic, Harmonics, Tissue Doppler. Connectivity: Transducer ports. Electrical safety: Complies with FDA Track 3 limits. Materials: Biocompatible. Software: Signal processing for image reconstruction and Doppler shift analysis.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in ophthalmic, fetal, abdominal, pediatric, intraoperative (vascular, epicardial, neuro), musculoskeletal, peripheral vascular, small organ, cardiac (adult, pediatric), endocavity (trans-rectal, trans-vaginal), adult/neonatal cephalic, and gynecological applications. Prescription use only.
Regulatory Classification
Identification
A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.
Predicate Devices
- M2540 ultrasound systems (K014191)
- Boris platform diagnostic ultrasound system (K030455)
Reference Devices
Related Devices
- K022303 — PHILIPS M2424 DIAGNOSTIC ULTRASOUND SYSTEM &PHILIPS 21315 DIAGNOSTIC ULTRASOUND TRANSDUCER · Philips Ultrasound, Inc. · Jul 30, 2002
- K160790 — Acclarix LX8 Diagnostic Ultrasound System · Edan Instruments, Inc. · Apr 4, 2016
- K081661 — HD15 DIAGNOSTIC ULTRASOUND SYSTEM · Philips Ultrasound, Inc. · Jun 24, 2008
- K043535 — HD11 DIAGNOSTIC ULTRASOUND SYSTEM · Philips Ultrasound, Inc. · Jan 6, 2005
- K110673 — HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER · Hitachi Medical Systems America, Inc. · Sep 27, 2011
Submission Summary (Full Text)
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K083872
# JAN 1 3 2009
510(k) Premarket Notification
FLYING Diagnostic Ultrasound system
#### 3.2 Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 as implemented in 21 C.F.R. 8807.92.
The submitter of this premarket notification is:
Tian Yanfang
Manager of Quality Management Department No,16 Shiji Road,Hunnan District,Shenyang,China,110179 T: +86 24 83660649 F: +86 24 83780480
This summary was prepared on May 19, 2008.
The proprietary name of the device is the FL YING Diagnostic Ultrasound System. In combination with transducers - L12-3, L12-5 50, 15-6L, S4-2, S8, C5-2, D5009V, E6509, C8-4V- are commonly known as a diagnostic ultrasound system and transducers.
These devices are classified as follows:
Ultrasonic Pulsed Doppler Imaging System 90IYN
Ultrasonic Pulsed Echo Imaging System 90IYO
90ITX Diagnostic Ultrasound Transducer
As stated in 21 CFR, parts 892.1550, 892.1560 and 892.1570, each of these generic types of devices have been classified as Class II.
The FLYING is a diagnostic ultrasound device. It consists of a system console containing o the power supply and electronic circuitry required to generate the image, a display screen. and a connection to the separate transducers. It is substantially equivalent to the currently marketed M2540 ultrasound systems and transducers cleared in K014191 and Boris platform diagnostic ultrasound system cleared in K030455.
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The FLYING system and transducers function in a manner identical to all Philips ultrasound systems and transducers. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo-electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The differing acoustic properties of the tissues in the body reflect some of the transmitted energy back to the transducer, where it is converted back to electrical signals and sent back to the system. In the system, advanced signal processing technologies convert the returned signals into images of the Doppler functions of this system process the Doppler shift frequencies from the echoes of moving targets (such as blood), to detect and graphically display the Doppler shifts of these tissues as flow.
The FLYING is intended for diagnostic ultrasound imaging and fluid flow analysis. It is intended for diagnostic ultrasound imaging in B. M. Pulse Wave Doppler, Continuous Wave Doppler, Panoramic, Color Power Angio (CPA, formerly Angio), 3D. Harmonics, Directional Angio Imaging, Tissue Doppler Imaging and combined mode (see table 4.3.2). It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic.Fetal.Abdominal.Pediatric.Intraoperative (vascular, evicardial. neuro),Musculoskeletal, Peripheral Vascular, Small Organ, Cardiac (Adult, Pediatric),Endocavity (Trans-rectal, Trans-vaginal),Adult and Neonatal Cephalic, Gynecological
The FLYING is substantially equivalent in safety and effectiveness to the predicates identified above:
- . Both the predicate device and the FLYING are indicated for the diagnostic ultrasonic imaging and fluid flow analysis.
- Both the predicate device and the FLYING have the same gray-scale and Doppler ● capabilities.
- Both the predicate device and the FLYING use essentially the same technologies for . imaging, Doppler functions and signal processing.
- Both the predicate device and the FLYING have acoustic output levels below the Track 3 . FDA limits.
- . Both the predicate device and the FLYING are manufactured under equivalent quality systems.
- Both the predicate device and the FL YING are manufactured of materials with equivalent . biosafety. The materials have been evaluated and found to be safe for this application.
- a Both the predicate device and FLYING are designed and manufactured to the same electrical and physical safety standards.
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
#### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Neusoft Medical Systems Co., Ltd. % Mr. Tamas Borsai Division Manager, Medical Division TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K083877
Trade/Device Name: FLYING Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYO, ITX. and IYN Dated: December 23, 2008 Received: December 29, 2008
Dear Mr. Borsai:
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.
JAN 1 3 2009
This determination of substantial equivalence applies to the following transducers intended for use with the FLYING Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
S4-2 Sector S8 Sector L12-3 Linear Array L12-5 50 Linear 15-6L Linear Array
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## C5-2 Curved Linear C8-4v Curved Linear E6509 Endocavity D5009V Non-imaging pencil
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 (OS) 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 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 Paul Hardy at (240) 276-3666.
Sincerely vours.
Vorut Whay
Co Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
ﮩ
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FLYING Diagnostic Ultrasound system
#### Indications for Use Tables 4.3.2
### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
| 510(k) Number: | K083877 | | | | | | | | |
|-----------------------------|--------------------------------------------------------------------------------------------------|---|-------------------|-----|-----|------------------|-----------------------|---------------------|--|
| Device name: | FLYING Diagnostic Ultrasound System | | | | | | | | |
| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | |
| Clinical Application | | | Mode of Operation | | | | | | |
| General | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) | |
| (Track I<br>Only) | | | | | | | | | |
| Ophthalmic | Ophthalmic | N | N | N | N | N | N | N | |
| | Fetal/Obstetric | N | N | N | N | N | N | N | |
| | Abdominal | N | N | N | N | N | N | N | |
| | Intra-operative<br>(vascular/epicardial) | N | N | N | N | N | N | N | |
| | Intra-operative (Neuro) | N | N | N | | N | N | N | |
| | Laparoscopic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | N | N | N | N | N | N | N | |
| | Small Organ (thyroid, scrotum,<br>prostate, breast) | N | N | N | | N | N | N | |
| | Neonatal Cephalic | N | N | N | | N | N | N | |
| | Adult Cephalic | N | N | N | N | N | N | N | |
| | Trans-rectal | N | N | N | | N | N | N | |
| | Trans-vaginal | N | N | N | | N | N | N | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (Gynecological) | N | N | N | N | N | N | N | |
| | Cardiac Adult | N | N | N | N | N | N | N | |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | N | N | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Other (Fetal) | N | N | N | | N | N | N | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | N | N | |
| | Other (Specify) | | | | | | | | |
| | Musculo-skel (conventional) | N | N | N | | N | N | N | |
| | Musculo-skel (superficial) | N | N | N | | N | N | N | |
| | N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | |
* Other modes: Color Power Angio, 3-D Imaging, Panoramic, Harmonics (Tissue & Contrast), , Directional Angio Imaging, Tissue Doppler Imaging
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color
Previous submission: No previous 510(k)s are associated with this product
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
htqui mothy
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
ﺮ ﮐﮯ
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### FLYING Diagnostic Ultrasound system
| 510(k) Number: | System: FLYING Diagnostic Ultrasound System<br>Transducer: S4-2 Sector transducer | | | | | | | |
|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--------------------|
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General<br>(Track I<br>Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | P | P | P | P | P | P | P |
| Fetal<br>Imaging<br>& Other | Fetal/Obstetric | P | P | P | P | P | P | P |
| | Abdominal | P | P | P | P | P | P | P |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (thyroid, scrotum,<br>prostate, breast) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | P | P | P | P | P | P | P |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Gynecological) | P | P | P | P | P | P | P |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P |
| | Cardiac Pediatric | P | P | P | P | P | P | P |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Fetal) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | E | E | E | E | E | E | E |
| | Other (Specify) | | | | | | | |
### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Musculo-skel (conventional) Musculo-skel (superficial)
* Other modes include: Color Power Angio, 3D, Panoramic, Harmonics, Directional Angio Imaging, Tissue Doppler Imaging
Combined modes:. Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color Previous submission: K014191 for Ophthalmic, Fetal, Abdominal, Pediatric, Adult Cephalic, Adult &
Pediatric Cardiac. K043535 for Gynecological, Peripheral Vessel.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
forni M. Whan
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
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| 510(k) Number: | System: FLYING Diagnostic Ultrasound System | | | | | | | |
|-----------------------------|--------------------------------------------------------------------------------------------------|---|---|-------------------|-----|------------------|-----------------------|---------------------|
| Transducer: | S8 Sector transducer | | | | | | | |
| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
| Clinical Application | | | | Mode of Operation | | | | |
| General | Specific | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| (Track I<br>Only) | (Tracks I & III) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetric | P | P | P | | P | P | P |
| | Abdominal | P | P | P | P | P | P | P |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (thyroid, scrotum,<br>prostate, breast) | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | P | P |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Gynecological) | P | P | P | P | P | P | P |
| | Cardiac Adult | P | P | P | P | P | P | P |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Fetal) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | P | P |
| | Other (Specify) | | | | | | | |
| | Musculo-skel (conventional). | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E *Other modes: Color Power Angio, 3D, Panoramic, Directional Angio Imaging, Tissue Doppler Imaging
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color Previous submission: K014191
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
Lori M. Holm
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic
510(k) Number
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| 510(k) Number: | | | | | | | | |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|-----------------------|---------------------|
| System: | FLYING Diagnostic Ultrasound System | | | | | | | |
| Transducer: | L12-3 Linear ArrayTransducer<br>Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
| Clinical Application | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| General<br>(Track I Only) | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Ophthalmic | | | | | | | |
| | Fetal/Obstetric | P | P | P | | P | P | P |
| | Abdominal | P | P | P | | | P | |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | P |
| | Small Organ (thyroid, scrotum,<br>prostate, breast) | P | P | P | | P | P | P |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Fetal) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | P | P |
| | Other (Specify) | | | | | | | |
| | Musculo-skel (conventional) | P | P | P | | P | P | P |
| | Musculo-skel (superficial) | P | P | P | | P | P | P |
| | N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | |
Imaging Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color
Previous submission: K014191
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
Vornt Artz
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
Radiological Devices
510(k) Number
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| 510(k) Number: | | | | | | | | |
|------------------------------|--------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| | System: FLYING Diagnostic Ultrasound System | | | | | | | |
| Transducer: | L12-5 50 Linear Transducer | | | | | | | |
| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General<br>(Track I<br>Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetric | E | E | E | | E | E | E |
| | Abdominal | E | E | E | | E | E | E |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | P | P | P | | P | P | P |
| | Small Organ (thyroid, scrotum,<br>prostate, breast) | P | P | P | | P | P | P |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Fetal) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | P | P |
| | Other (Specify) | | | | | | | |
| | Musculo-skel (conventional) | P | P | P | | P | P | P |
| | Musculo-skel (superficial) | P | P | P | | P | P | P |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
*Other modes: Color Power Angio, Panoramic, Directional Angio Imaging Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color
Previous submission: K991671 for Intraoperative (Abdominal and Vascular Small Parts,) Musculo-skeletal (conventional and Superficial), Pediatric, Peripheral Vascular
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
Arni M. Nohr
(Division Sign Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number
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510(k) Number: System: FLYING Diagnostic Ultrasound System Transducer: 15-6L Linear array transducer Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General Specific B PWD CWD M Color Combined Other* (Track I (Tracks I & III) Doppler (Specify) (Specify) Only) Ophthalmic Ophthalmic Fetal/Obstetric Abdominal Intra-operative P P P P P P (vascular/epicardial) Intra-operative (Neuro) P P P P P -P Laparoscopic Pediatric Fetal P P P P . P Imaging & Other Small Organ (thyroid, scrotum, P P P b P P prostate, breast) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Intra-luminal Other (Gynecological) Cardiac Adult Cardiac Cardiac Pediatric Trans-esoph. (Cardiac) Other (Fetal) Peripheral Peripheral vessel P P P P P ﺔ Vessel Other (Specify) Musculo-skel (conventional) P P P P P p Musculo-skel (superficial) N= new indication; P= previously cleared by FDA; E= added under Appendix E *Other modes: Amplitude Doppler, Panoramic, Directional Angio Imaging Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color Previous submission: K014191
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
Lorgai In Witz
(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number
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.
..
| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
|------------------------------|--------------------------------------------------------------------------------------------------|---|---|-----|-----|-------------------|-----------------------|---------------------|
| Clinical Application | | | | | | Mode of Operation | | |
| General<br>(Track I<br>Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetric | P | P | P | | P | P | P |
| | Abdominal | P | P | P | | P | P | P |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | P | P | P | | P | P | P |
| | Small Organ (thyroid, scrotum,<br>prostate, breast) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Gynecological) | P | P | P | | P | P | P |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Fetal) | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | P | P |
| Vessel | Other (Specify) | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
| | N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | |
# DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801 109)
Previous submission: K043535
longi In Whang
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi
510(k) Number
ﻧﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺮﻳﺐ ﺍﻟﺘﻲ ﺗﺮﻛﻴﺐ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺮﺍﺗﺐ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
{11}------------------------------------------------
510(k) Number: System: FLYING Diagnostic Ultrasound System
Transducer: C8-4v Curved Linear Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---|-------------------|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track I<br>Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal/Obstetric | P | P | P | | P | P | P |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (thyroid, scrotum,<br>prostate, breast) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | P | P | P | | P | P | P |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Gynecological) | P | P | P | | P | P | P |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Fetal) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | |
| | *Other modes: SonoCT, X-Res, Color Power Angio, Panoramic, 3-D Imaging, Directional Angio Imaging | | | | | | | |
| | Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual | | | | | | | |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
tom Whang
1381
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device
510(k) Number.
{12}------------------------------------------------
# DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
| 510(k) Number: | | | | | | | | |
|-----------------------------|--------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| | System: FLYING Diagnostic Ultrasound System | | | | | | | |
| Transducer: | E6509 Endocavity transducer | | | | | | | |
| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General | Specific | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| (Track I<br>Only) | (Tracks I & III) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetric | P | P | P | | P | P | P |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | |
| | Small Organ (thyroid, scrotum,<br>prostate, breast) | P | P | P | | P | P | P |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P |
| | Trans-vaginal | P | P | P | | P | P | P |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Fetal) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
*Other modes: Color Power Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging, Tissue doppler Imaging
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color
Previous submission: K014191
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
Agnus M. Witz
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
Page 22
510(k) Number
{13}------------------------------------------------
### FLYING Diagnostic Ultrasound system
| Clinical Application | | Mode of Operation | | | | | | |
|------------------------------|-----------------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--------------------|
| General<br>(Track I<br>Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal/Obstetric | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (thyroid, scrotum,<br>prostate, breast) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Fetal) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | P | P | | | |
| | Other (Specify) | | | | | | | |
# DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
(PLEASE DO NOT WRITE BELOW THIS LINE…
