(7 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Intraoperative (specify): N1 (16MHz Probe)
Intraoperative Neurological: N (16MHz Probe)
Adult Cephalic: N (1MHz TCD Probe); P (2MHz TCD Probe, 2MHz TCD Monitoring Probe)
Peripheral Vascular: p3 (Doppler-Box System); P (4MHz Pencil Probe, 8MHz Pencil); N (4MHz Monitoring)
The Doppler-Box only contains the Doppler hardware, everything else (e.g. QL software, database) is located on a standard PC that is connected to the Doppler-Box. The probes are connected to the Doppler-Box. All sonograms are saved on the PC and can be evaluated, printed and archived. The QL software was especially designed for the Doppler-Box. At the same time, the QL software features an M-Mode. All gates are displayed in one window thus orientation is a lot easier. The Doppler-Box can be used together with the appropriate probes for the entire ultrasound diagnostic (1MHz and 2MHz Probes can work simultaneously, and functional physiological tests can be performed).
This FDA 510(k) summary for the Doppler-Box system is for substantial equivalence to predicate devices, not for a de novo marketing authorization. Therefore, it does not typically include clinical performance studies with acceptance criteria in the same way a novel device might. The "study" here is more focused on demonstrating that the device meets safety and performance standards equivalent to existing legally marketed devices, primarily through technical specifications and comparisons.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating equivalence to predicate devices (Spencer Technologies TCD 100M and DWL Elektronische Systeme GmbH Multi-Dop® X) and compliance with the IEC 61157 performance standard (for acoustic output). The reported performance is primarily in terms of acoustic output parameters.
| Acceptance Criteria Category | Specific Criteria (Reference/Standard) | Reported Device Performance (Doppler-Box) |
|---|---|---|
| Substantial Equivalence | Demonstration that the Doppler-Box has the same intended use and similar technological characteristics to the predicate devices (Spencer Technologies TCD 100M, K002533; DWL Elektronische Systeme GmbH Multi-Dop® X, K931801). Any differences do not raise new questions of safety or effectiveness. | The Doppler-Box is described as "similar to currently distributed pulsed Doppler ultrasound systems." It contains Doppler hardware, and the software runs on a standard PC. It allows for measurements of blood flow velocities in arteries and display of signals in an FFT. Its intended uses (e.g., Adult Cephalic, Peripheral Vascular, Intraoperative Neurological with various probes) align with standard clinical applications for TCD devices, with some new indications identified (N) as part of the submission, but these are still within the scope of ultrasonic pulsed Doppler imaging. The submission explicitly states: "The Doppler-Box is substantially equivalent to predicate devices described herein." |
| Acoustic Output Safety | Maximum acoustic output level under the FDA recommended limit as defined by IEC 61157. | "Maximum acoustic output level is under by the FDA recommended limit and power level is displayed all the time." The following acoustic output parameters were measured for various probes: - 1MHz TCD Probe: ISpTA.3=484 mW/cm², ISpPA.3=4.84 W/cm², Power=206 mW, MI=0.376, TIC=3.22, PD=20.0 µs, PRF=5000 Hz - 2MHz TCD Monitoring Probe: ISpTA.3=524.5 mW/cm², ISpPA.3=17.48 W/cm², Power=111.2 mW, MI=0.465, TIC=1.99, PD=20.0 µs, PRF=1500 Hz - 2MHz TCD Probe: ISpTA.3=490 mW/cm², ISpPA.3=18.55 W/cm², Power=123.7 mW, MI=0.469, TIC=1.93, PD=13.0 µs, PRF=2000 Hz - 4MHz Pencil Probe: ISpTA.3=319.9 mW/cm², ISpPA.3=4.00 W/cm², Power=17.17 mW, MI=0.167, PD=20.0 µs, PRF=4000 Hz - 4MHz Monitoring Probe: ISpTA.3=635.7 mW/cm², ISpPA.3=15.89 W/cm², Power=42.6 mW, MI=0.318, PD=20.0 µs, PRF=2000 Hz - 8MHz Pencil Probe: ISpTA.3=434.7 mW/cm², ISpPA.3=16.72 W/cm², Power=18.1 mW, MI=0.199, PD=13.0 µs, PRF=2000 Hz - 16MHz Intraoperative Probe: ISpTA.3=64.0 mW/cm², ISpPA.3=0.64 W/cm², Power=0.722 mW, MI=0.032, PD=5.0 µs, PRF=12000 Hz |
| Biocompatibility | Probes coming into contact with patients must be made of biocompatible materials. | Materials of probes coming into contact with patient are: Lexan® ®, POM, Epoxy Resin (all USP-Class VI). |
| Software Functionality | Software collects and processes "rough" data, sends it to a PC, and allows for displaying, processing, and managing data, including displaying velocity spectrum, calculating envelopes, and performing functional tests. | "The Doppler-Box contains the hardware and software which collects and processes "rough" data and sends it via network connection to a Windows® based PC. The main application software is a software running on the PC, it is presenting data, probing and calculating, and managing data [...] The main user screen shows a v-spectrum. All gates may be seen calculated. Envelopes can be recorded and functional test can be performed." The QL software includes "M-Mode" and allows for simultaneous use of probes. |
2. Sample Size Used for the Test Set and Data Provenance
This is a 510(k) submission primarily focused on demonstrating substantial equivalence through technical specifications and comparison to predicate devices, and adherence to performance standards (IEC 61157).
- Test Set Sample Size: The document does not describe a clinical "test set" with a specific number of patients or samples in the way a clinical trial would. The "tests" mentioned are for acoustic output measurements and material biocompatibility. These are typically laboratory-based tests on the device itself and its components, not an evaluation using patient data.
- Data Provenance: Not applicable in the context of a clinical test set from patients. The data presented (acoustic output) would be derived from laboratory measurements of the Doppler-Box system and its probes. The manufacturer, Compumedics Germany GmbH, is based in Germany, implying the development and initial testing likely occurred there.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This type of submission relies on technical standards compliance and comparison to previously cleared devices, not on expert-adjudicated clinical ground truth from a test set of patient data.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication is described.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an ultrasound Doppler system, not an AI-assisted diagnostic tool, and no MRMC study is mentioned or implied.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The Doppler-Box is a hardware and software system that provides data for human interpretation (e.g., clinicians reading velocity spectra). It is not an algorithm performing a standalone diagnostic function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the clinical sense. The "ground truth" for this submission revolves around:
- Technical Specifications: Demonstrating that the device's technical characteristics (e.g., acoustic output) meet regulatory limits and are similar to predicate devices.
- Biocompatibility Standards: Evidence that materials are USP-Class VI.
- Functional Equivalence: The software performs functions analogous to those found in predicate devices.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning system that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
Not applicable. (See point 8.)
{0}------------------------------------------------
MAY - 5 2005
K 051085
Valid from: 01/15/2005 Revision: 0 Page 1 of 2
Page 1 of 2
File: FDA-Summary-for-DopplerBox-rev0.doc
Doppler-Box 510 (k) 510K Summary
Stalus: F
Image /page/0/Picture/5 description: The image shows a logo with a stylized letter 'G' in a circle. Inside the 'G', there's a cursive letter 'M'. Below the circle, there's some smaller text that appears to say 'COSMETICS DIVISION'. The overall design is simple and likely represents a company or brand in the cosmetics industry.
GW / EM Written by: 01/15/2005 Oste:
510K Summary
| 1. | Identifying Information | |
|---|---|---|
| Manufacturer:Address: | Compumedics Germany GmbHJosef-Schuettler Str. 2D-78224 SingenGermany | |
| Telephone:Fax:E-Mail : | +49 7731 79769 0+49 7731 79769 99info@dwl.de | |
| Contact : | Gerold Widenhorn / Engineering Manager | |
| Name of Device : | Doppler-Box | |
| 2. | Class and Predicate Information | |
| Classification Name: | Ultrasonic pulsed Doppler imaging system 892.1550 | |
| Common Name: | Ultrasound Doppler System | |
| Proprietary Name: | Doppler-Box | |
| Class: | Regulatory Class II | |
| Predicate Device: | Spencer Technologies; TCD 100M, PWD13 TRANSDUCERDWL Elektronische Systeme GmbH; Multi-Dop® X | K002533K931801 |
Performance Standards ర్లుక
None Performance Standards: Performance Standards: IEC61157
Indications for Use 4.
The Doppler-Box is a medical ultrasound device for measuring the blood flow velocities in arteries and The Doppler-Box is a medical ultrasound occidential linguoung in the problem.
Device Description 5.
The Doppler-Box only contains the Doppler hardware, everything else (e.g. OL software, database) is
t the former of the first be consected to the Doppler Box . Misimum requir The Dopper-Box only contains in Doppier hardware, everything close very on the more of the more of the more of the more located on a standard PC that is connected in the Doppler-Box. warman are saved on the PC and can
the PC. The probes are connected to the Doppier-Box. All sonograms are saved the PC. The probes are connected to the Doppler only carsoned for the Doplerthere be evaluated, printed and archived. The QL solinare was especially as a was and
{1}------------------------------------------------
Valid from: 01/15/2005 Boursion: C Page 2 ol 2
File: FDA-Summary-for-Doppler Box-rev0, dos
Image /page/1/Picture/2 description: The image shows a logo with a stylized letter 'C' forming a semi-circle at the top. Inside the 'C', there's a cursive letter 'M'. Below the 'C', the word 'COMPONENTS' is written in a small, sans-serif font, and underneath that, the letters 'DWVL' are displayed in a larger, bolder font, possibly representing an acronym or brand name.
Status: F
at the same time, the QL software features an M-Mode. All gates are displayed in one window thus oriat the same time, the QL software teatures an be used to eapley of the appropriate probes for the entire is a lot easier. The Dopler-Box can be used rogether and probe extracrania
entire ultrasound diagnostice), Two probes canscrania, 4MHz and Millaneously, and luncional entire ultrasound diagnostic (1MHz and 2MHz Probes can work simultaneously, and functional physiological lests can be performed.
General Safety and Effectiveness 6.
The Dopler-Box is similar to currently distributed pulsed Doppler ultrasound systems. The Doppler The Doppler-Box is similar to currently distributed pulsed by the FDA recommended limit
signal is displayed in a FFT. Maximum acoustic output level is under by the FDA recomm and power level is displayed all the time.
Following acoustic output parameters (mean) have been measured
| Probe | ISPTA.3(mW/cm²) | ISPPA.3(W/cm²) | Power[mW] | MI | TIC | PD[us] | PRF[Hz] |
|---|---|---|---|---|---|---|---|
| 1MHz TCD Probe | 484 | 4,84 | 206 | 0.376 | 3.22 | 20.0 | 5000 |
| 2MHz TCD Monitoring Probe | 524,5 | 17,48 | 111,2 | 0.465 | 1.99 | 20.0 | 1500 |
| 2MHz TCD Probe | 490 | 18,55 | 123.7 | 0.469 | 1.93 | 13.0 | 2000 |
| 4MHz Pencil Probe | 319.9 | 4.00 | 17.17 | 0.167 | - | 20.0 | 4000 |
| 4MHz Monitoring Probe | 635.7 | 15.89 | 42.6 | 0.318 | - | 20.0 | 2000 |
| 8MHz Pencil Probe | 434.7 | 16.72 | 18.1 | 0.199 | - | 13.0 | 2000 |
| 16MHz Intraoperative Probe | 64.0 | 0.64 | 0.722 | 0.032 | - | 5.0 | 12.000 |
· TIC for TCD Probes only
Patient Contact Material 7.
The materials of probes, coming in contact with patient are: The Thatenals POM, Epoxy Resin (all USP-Class Vi)
Software 8.
The Dopler-Box contains the hardware and software which collects and processes "rough" data The Dopler-Box contains the hardware and sonward and propiezion software is a
and sends it via network connection to a Windows® based PC . The main appliedion software is a and sends it via network connection it a vinconsing and man a phowing data on the Windows® software running on the PC, it is lecenting data, probobing and indical of the may be see calcuscreen. The main user screen shows a v 7 - spectice , " .
lated. Envelopes can be recorded and functional test can be performed.
Conclusion ਕੇ
In accordance with the FDA and based on the information provided in this Premarket notification In accordance with the FDA and based on the information provided in the ventually equivalent to predicate devices described herein.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. The overall design is simple and symbolic, representing the department's role in health and human services.
Public Health Service
MAY - 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Compumedics Germany GmbH % Mr. Stefan Preiss Responsible Third Party Official TÜV Product Services 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891
Re: K051085
Trade Name: Doppler-Box System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN and ITX Dated: April 26, 2005 Received: April 28, 2005
Dear Mr. Preiss:
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 the goneral controls provision, 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 Doppler-Box System, as described in your premarket notification:
Transducer Model Number
l MHz TCD Probe 2 MHz TCD Probe 2 MHz TCD Monitoring Probe 4 MHz Pencil Probe
4 MHz Monitoring 8 MHz Pencil 16 MHz Probe
{3}------------------------------------------------
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) into existing major regulations affecting your device in this production in this prod if may be subject to such additional comrons. Enemage of January of Sept. In addition, FDA can be found in the Code of Feactal concerning your device in the Federal Register. may publish further announce of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a studenice complies with other requirements of the Act that FDA has made a decommancis an administered by other Federal agencies. You must or any Federal Statutes and regulations and limited to: registration and listing (21 comply will an the Act 3 requirements, nisi and as a manufacturing practice requirements as set CFR Part 807), labeling (21 CFRT art 807), good management of applicable, the electronic forth in the quality systems (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 I his letter will anow you to begin marketing your device to a legally marketed notification. The I D73 midming of bastian 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 If you desire specific acrise for your as (240) 276-0120. Also, please note the regulation entitled, Comaci the Office of Compunes as (21 transmit (21CFR Part 807.97). You may obtain " Misofanumig by reference to promanto nibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-204 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
Doppler-Box System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | N1 | |||||||||
| Intraoperative Neurological | N | |||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | p2 | |||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | p3 | P | ||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Dopler-Box System
Note 1: The 16MHz Probe can be used directly on the vessel during operation
Note 2: The 1MHz Probe is a new indication the 2MHz Probes are previously cleared by FDA
Note 3: The 4MHz Monitoring Probe is a new indication the 4MHz Pencil Probe is previously cleared
by FDA
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brandon
.
{5}------------------------------------------------
1MHz TCD Probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | 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 | ||||||||||
| Adult Cephalic | N | |||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
N= new indication; P= previously cleared by FDA;
Additional Comments:_
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Broughton
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K051085
510(k) Number
{6}------------------------------------------------
2MHz TCD Probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | P | |||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
Other (spoal)
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:_
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy Brogdon
(Division Sign-Off Division of Reproducti Abdomir and Radiological Devices 510(k) Number
Chapter B . p.5
{7}------------------------------------------------
2MHz TCD Monitoring Probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | P | ||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brandon
(Division Sign-Off) Division of Reproductive, A and Radiological Device 510(k) Number
{8}------------------------------------------------
4MHz Pencil Probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | |||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .
{9}------------------------------------------------
4MHz Monitoring
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
.
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
Sale (spear)
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:__
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
(Division Sigh-Off) Division of Reproductive, Abdominal, and Radiological Devices 1085 510(k) Number _
{10}------------------------------------------------
8MHz Pencil
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | |||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) |
Other (spear)
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:__________________________________________________________________________________________________________________________________________________________
,
- -.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Manent Bogdan
(Division Sign-Off)
Division of Reproductive, Abdo and Radiological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
Chapter B - p 9
{11}------------------------------------------------
16MHz Probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | N¹ | - | ||||||||
| Intraoperative Neurological | N | |||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
Onler (spoal))
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:_
Note 1: The 16MHz Probe can be used directly on the vessel during operation
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brandon
(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.