ULTRASOUND SCANNER MINI FOCUS, MODEL 1402
Device Facts
| Record ID | K043554 |
|---|---|
| Device Name | ULTRASOUND SCANNER MINI FOCUS, MODEL 1402 |
| Applicant | B-K Medical A/S |
| Product Code | IYN · Radiology |
| Decision Date | Jan 14, 2005 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal (Obstetrics), Intraoperative, Pediatrics, Transrectal, Transvaginal, Peripheral vascular, Muskulo-skeletal (conventional and superficial).
Device Story
Ultrasound Scanner Mini Focus 1402 is a diagnostic ultrasound system supporting B-mode, M-mode, PWD, CW, and CFM (Color/Amplitude Doppler) modes, including tissue harmonic imaging. It utilizes linear, convex, and mechanical sector transducers to acquire ultrasound signals. The system performs geometric measurements and calculations for vascular, urology, cardiology, and OB/GYN applications; guides biopsy/puncture needles; and reconstructs 2D images into 3D volumes via freehand tracking. Operated by clinicians in clinical settings, the system displays images and measurements on-screen to assist in diagnosis and clinical decision-making. It provides non-invasive visualization of internal structures and blood flow, aiding in patient assessment and procedural guidance.
Clinical Evidence
Bench testing only. The device underwent thermal, mechanical, and electrical safety testing by a certified body. Acoustic output reporting was performed in accordance with FDA guidance for diagnostic ultrasound systems.
Technological Characteristics
System supports B, M, PWD, CW, and CFM modes. Transducers include linear, convex, and mechanical sector arrays. Patient-contact materials are biocompatible. Acoustic output complies with Track 3 limits (Ispta ≤ 720 mW/cm², MI ≤ 1.9, TI ≤ 6.0). Features include 3D reconstruction (freehand tracking) and needle guidance. Connectivity includes standard ultrasound imaging interfaces.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in abdominal, cardiac, fetal/obstetric, intraoperative, pediatric, transrectal, transvaginal, peripheral vascular, and musculoskeletal (conventional/superficial) applications.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- Ultrasound Scanner Type 2400 (K024236)
Related Devices
- K132685 — ULTRASOUND SCANNER PRO FOCUS 2202 · B-K Medical Aps · Jan 6, 2014
- K024236 — ULTRASOUND SCANNER, TYPE 2400 · B-K Medical A/S · Jan 17, 2003
- K123254 — ULTRASOUND SCANNER FLEX FOCUS · B-K Medical Aps · Feb 13, 2013
- K132346 — ULTRASOUND SCANNER PRO FOCUS 2202 · B-K Medical Aps · Jan 10, 2014
- K132677 — ULTRASOUND SCANNER FLEX FOCUS 1202 · B-K Medical Aps · Jan 7, 2014
Submission Summary (Full Text)
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### 510(k) Summary:
### JAN 1 4 2005
K043554
Page 1 of 2
This summary is provided as part of this Premarket Notification in compliance with 21CRF, Section 807.92.
Submitters name: B-K Medical Address: Mileparken 34, DK2730 Herlev, Denmark Phone: +45 44528100 Fax: +45 44528199 Contact person: Villy Braender, Regulatory Manager Date prepared: 22 December, 2004
Trade name: Ultrasound Scanner Mini Focus 1402 Common name: Diagnostic Ultrasound System Classification names: Ultrasonic Pulsed Echo Imaging System (90 IYO, CFR 892.1560) Ultrasonic Pulsed Doppler Imaging System (90 IYN, CFR 892.1560) (90 ITX, CFR 892.1570) Diagnostic Ultrasonic Transducer
Identification of predicate, legally marketed device: B-K Medical Ultrasound Scanner Type 2400, K024236 (JAN17 2003)
#### Device description:
Mini Focus 1402 supports the following scanning modes and combinations thereof: B-mode, M-mode, PWD mode, CFM mode. B mode includes tissue harmonic imaging. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications.
The system can guide biopsy- and puncture needles.
The system can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. (Freehand tracking)
#### Transducers
Transducers are linear and convex arrays and mechanical sector. The patient contact materials are biocompatible. All transducers used together with Mini Focus 1402are Track 3 transducers.
#### Acoustic output
The system controlling the Acoustic Output in Mini Focus 1402is the same as the system in 2400. The system will assure that the acoustic output always will stay below the pre-amendments upper limits i.e. Ispta ≤ 720 mW/cm² and MI ≤ 1.9 (Track 3, non ophthalmic). The Thermal Index values are maximum 6.0, i.e. TI ≤ 6.0
#### Clinical measurement accuracy.
Clinical measurements and calculations are described and accuracies are provided in the User Guide.
Thermal, mechanical and electrical safety. The scanner Mini Focus 1402 has been tested by a recognized, Certified Body.
Acoustic Output Reporting
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The Acoustic Output Reporting is made according to the standards required by "Informations Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 30, 1997"
#### Intended use.
1402 intended uses are contained within 2400-intended uses:
| | Predicate device: | Submitted device: |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Ultrasound scanner Type 2400 | Ultrasound scanner Mini Focus 1402 |
| | K024236 (JAN17 2003) | |
| Modes of operation | B, M, PWD, CFM 1) and combinations. Tissue harmonic imaging | B, M, PWD,CW, CFM 1) and combinations. Tissue harmonic imaging |
| Intended use(clinical application) | Abdominal<br>Cardiac<br>Fetal<br>Intraoperative<br>Neurosurgery<br>Obstetrics<br>Pediatrics<br>Transrectal<br>Small Parts (organs)<br>Transvaginal<br>Peripheral vascular<br>Muskulo-skeletal (conventional and superficial) | Abdominal<br>Cardiac<br>Fetal (Obstetrics)<br>Intraoperative<br>Pediatrics<br>Transrectal<br>Small Parts (organs)<br>Transvaginal<br>Peripheral vascular<br>Muskulo-skeletal (conventional and superficial) |
| Features | ECG (not monitoring) | Untracked 3D |
1) CFM= Color Flow Mapping=Color Doppler and Amplitude Doppler.
### Technological characteristics compared to the predicate device.
The predicate device has the same major technological characteristics as the subject device described above.
Minor differences consist: Modified beamformer and operating system, modified mechanical outline and 3D imaging.
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NAN 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Villy Brænder Official Correspondent B-K Medical A/S Mileparken 34 Herlev 34, DK 2730 DENMARK
Re: K043554
Trade Name: Ultrasound Scanner Mini Focus 1402 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: December 22, 2004 Received: December 31, 2004
#### Dear Mr. Brænder:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your socure esternined 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 Interstate commerce prior to that have been reclassified in accordance with the provisions of the Amendinents, of to devices 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 general controls provisions of the Fiting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for I ins determination of substancial oqur. accuse in your premarket notification:
#### Transducer Model Number
| 8660 |
|------|
| 8665 |
| 8667 |
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| 8670 |
|------|
| 8803 |
| 8817 |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 11 your device is classified (doc acove) arols. Existing major regulations affecting your device in the It may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oode of reacting your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease oc advised that I Dri of issuantes or our device complies with other requirements of the Act that IDA has made a decorminations administered by other Federal agencies. You must or any it cach statutes and regainents, including, but not limited to: registration and listing (21 comply with an the Act 3 requirements, n.c., and manufacturing practice requirements as set CrK Fart 607), adomig (21 CFRT art 800), and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping I ms device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested information, metading acounts September 30, 1997 "Information for Manufacturers In Appendix U, (cherosou) of the Same tic Ultrasound Systems and Transducers." If the special SCCKing Manteling Orcaranter s unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and I ne special report ... CADD-TO-FILE" and should be submitted in duplicate to:
> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket I mis letter will anow you to begin mastering , "
notification. The FDA finding of substantial equivalence of your device to a legally marketed nontheation. The I Drivination 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 acressions of (240) 276-0120. Also, please note the regulation entitled, Connect the Office of Court Court Cation" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
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Page 3 - Mr. Brænder
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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### Diagnostic Ultrasound Indications for Use Form
#### System: 1402
## Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-------------------------------|----------------------|----------------------|------------------------------|-------------------------|--------------------|
| Clinical Application | A | B | M | PWD | Tissue<br>harmonic<br>imaging | Color<br>Doppl<br>er | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify 1) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P | |
| Abdominal | | P | P | P | P | P | P | | P | |
| Intraoperative (specify) | | P | P | P | P | P | P | | P | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P | |
| Small Organ (specify) | | P | P | P | P | P | P | | P | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | P | P | P | | P | |
| Transvaginal | | P | P | P | P | P | P | | P | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | P | P | P | | P | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | P | P | P | | P | |
| Musculo-skeletal Superficial | | P | P | P | P | P | P | | P | |
| Other (specify) | | | | | | | | | | |
Online (0000)
N= new indication; P= previously cleared by FDA; E= added under Appendix E
1) B+M, B+D, B+C, B+D+C. B mode includes Tissue Harmonic Imaging. Additional Comments:__________________________________________________________________________________________________________________________________________________________ D is PWD, C is Color Doppler and Amplitude Doppler. Fetal is often called Obstetrics
> (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 Divisio n of Reproductive, Abdominal. and Rac iological I 510(k) Number
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# diagnostic ultrasound Indications for use form
| System: | 1402 |
|-------------|------|
| Transducer: | 8660 |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------|-------------------|---|-----|-----|------------------|-----------------------|------------------------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Amplitude<br>e Doppler |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | P | P | P | | P | P 1) | P |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | P 1) | P |
| | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E * Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging
Additional Comments: Small Organ: Breast, testis, penis, thyroid, parathyroid, salivary glands, lymph nodes Adultions: Snan Organ Breas, Roam, Portal, C. (D is PWD, C is Color Flow mapping Doppler including Amplitude(power)Doppler)
(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)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number
{7}------------------------------------------------
| System: | 1402<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Transducer: | ୫୧୧୧ ହ<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------|-------------------|---|-----|-------------------------------|------------------|-----------------------|----------------------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | Tissue<br>harmonic<br>imaging | Color<br>Doppler | Combined<br>(Specify) | Amplitude<br>Doppler |
| Ophthalmic | Ophthalmic | P | P | P | P | P | P 1) | P |
| Fetal Imaging<br>& Other | Fetal | P | P | P | P | P | P 1) | P |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E N = new Indication; P = previously cleared by TDA, E = auded and : opposition = monic Imaging, Tissue Motion Doppler, Color Velocity Imaging
B+M, B+D, B+C, B+D+C. (D is PWD, C is l))Mode combinations: Additional Comments: Auditional Comments: ---------------------------------------------------------------------------------------------------------------------------------------------------------Fetal is often called Obstetrics
(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
Nancy C. Brogdon
ductive. Abd and Radiological Devi 510(k) Number
Prescription Use (Per 21 CFR 801.109)
・
{8}------------------------------------------------
| System: | 1402 |
|-------------|------|
| Transducer: | 8667 |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | |
|--------------------------|---------------------------|------------------------------|-------------------|---|-----|-----|------------------|-----------------------|------------------------|
| Intended User | General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Amplitude<br>e Doppler |
| | Ophthalmic | Ophthalmic | P | P | P | | P | P | P |
| | | Fetal | | | | | | | |
| | | Abdominal | | | | | | | |
| | | Intra-operative (Specify) | | | | | | | |
| | | Intra-operative (Neuro) | | | | | | | |
| | | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | | Pediatric | | | | | | | |
| | | Small Organ (Specify) | | | | | | | |
| | | Neonatal Cephalic | | | | | | | |
| | | Adult Cephalic | | | | | | | |
| | | Trans-rectal | P | P | P | | P | P 1) | P |
| | | Trans-vaginal | P | P | P | | P | P | P |
| | | Trans-urethral | | | | | | | |
| | | Trans-esoph. (non-Card.) | | | | | | | |
| | | Musculo-skel. (Conventional) | | | | | | | |
| | | Musculo-skel. (Superficial) | | | | | | | |
| | | Intra-luminal | | | | | | | |
| | | Other (Specify) | | | | | | | |
| Cardiac | | Cardiac Adult | | | | | | | |
| | | Cardiac Pediatric | | | | | | | |
| | | Trans-esoph. (Cardiac) | | | | | | | |
| | | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | | Peripheral vessel | | | | | | | |
| | | Other (Specify) | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
N= new marcation; r = previously Cleared by TDX, B = added ander + spenic Imaging, Tissue Motion Doppler, Color Velocity Imaging
B+M, B+D, B+C, B+D+C. (D is PWD, C is l))Mode combinations: Additional Comments: Auditonal Comments. Fetal is often called Obstetrics
(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)
Nancy C. Broadon
(Divisio Division of Reproductive, Abdominal. and Radiological Devices
510(k) Number
{9}------------------------------------------------
| System: | 1402 |
|-------------|------|
| Transducer: | 8670 |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------|-------------------|---|-----|-------------------------------|------------------|-------------------------|------------------------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | Tissue<br>harmonic<br>imaging | Color<br>Doppler | Combined<br>(Specify 1) | Amplitude<br>e Doppler |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify 2) | E | E | E | E | E | E | E |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | | | | | | | |
| | Small Organ (Specify 3) | E | E | E | E | E | E | E |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Conventional) | E | E | E | E | E | E | E |
| | Musculo-skel. (Superficial) | E | E | E | E | E | E | E |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | E | E | E | E | E | E | E |
| | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
N = new marcador, r = previousy cicaled by PDT, = = added and = = =
* Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging
Additional Comments: 2)Intraoperative: Breast, liver, pancreas, biliary system
2)Intraoperative: "Dreast, testis, thyroid, parathyroid, salivary glands, lymph nodes 1 ) mode combinations: B, B+M, B+C, B+C, B+D+C. (D is PWD, C is Color Flow mapping 1 / mode oomblitude(power)Doppler)
(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
Nancy brogdon
Division Sign-Off
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K043554
{10}------------------------------------------------
| System: | 1402 |
|-------------|------|
| Transducer: | 8803 |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------|-------------------|---|-----|-------------------------------|------------------|-----------------------|----------------------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | Tissue<br>harmonic<br>imaging | Color<br>Doppler | Combined<br>(Specify) | Amplitude<br>Doppler |
| Ophthalmic | Ophthalmic | P | P | P | P | P | P 1) | P |
| | Fetal | P | P | P | P | P | P 1) | P |
| | Abdominal | P | P | P | P | P | P 1) | P |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | P | P | P | P | P | P 1) | P |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
N = new Indication; P = previously cleared by FDA, E = added ander reportant =
* Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motio Color Velocity Imaging
B+M, B+D, B+C, B+D+C. (D is PWD, C is 1))Mode combinations: Additional Comments: Additional Comments.
Color Flow mapping Doppler including Amplitude(power)Doppler) _ Fetal is often called Obstetrics
(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
Nancy C. hogdon
eproductive. Abdominal. Divisio and R
510(k) Number K043554
{11}------------------------------------------------
| System: | 1402 |
|-------------|------|
| Transducer: | 8817 |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------|-------------------|---|-----|-----|------------------|-----------------------|-----------------------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Amplitud<br>e Doppler |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | P | P | P | | P | P 1) | P |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | P | P | P | | P | P 1) | P |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
* Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging
Additional Comments: 1) Mode combinations: B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow mapping Doppler including Amplitude(power)Doppler) ______________________________________________________________________________________________________________________
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Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Nancy Hodsdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
