ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202
Device Facts
| Record ID | K081154 |
|---|---|
| Device Name | ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 |
| Applicant | B-K Medical Aps |
| Product Code | IYO · Radiology |
| Decision Date | May 23, 2008 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal (incl Obstetrics), Intraoperative, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts (organs), Transvaginal, Peripheral vascular, Musculo-skeletal.
Device Story
Flex Focus 1202 is a diagnostic ultrasound system for clinical imaging and fluid flow analysis. It processes acoustic signals from linear, convex, phased, and mechanical sector transducers to generate B-mode, M-mode, PWD, CFM (Color/Amplitude Doppler), and Tissue Harmonic images. It supports geometric measurements and clinical calculations for vascular, urology, cardiology, and OB/GYN applications. An optional 3-D unit reconstructs 2-D images into 3-D volumes. Used in clinical settings by healthcare professionals for diagnostic guidance, including biopsy and puncture needle navigation. Output is displayed on-screen for real-time clinical decision-making, aiding in diagnosis and procedural guidance. The system maintains acoustic output within Track 3 limits (Ispta ≤ 720 mW/cm², MI ≤ 1.9, TI ≤ 6.0).
Clinical Evidence
Bench testing only. The device underwent verification of acoustic output, thermal, mechanical, and electrical safety by a recognized Certified Body. Clinical measurement accuracy was validated and described in the User Guide. No clinical trial data was required for this 510(k) submission.
Technological Characteristics
Diagnostic ultrasound system using linear, convex, phased, and mechanical sector arrays. Biocompatible patient contact materials. Operates in B, M, PWD, CFM, and Tissue Harmonic modes. Acoustic output controlled to Track 3 standards (Ispta ≤ 720 mW/cm², MI ≤ 1.9, TI ≤ 6.0). Includes 3-D reconstruction capability. System architecture includes modified scan converter, transmitter, and beamformer compared to predicate.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in patients requiring abdominal, cardiac, fetal/obstetric, intraoperative, transurethral, neurosurgical, pediatric, transrectal, small organ, transvaginal, peripheral vascular, or musculoskeletal assessment. Prescription use only.
Regulatory Classification
Identification
An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Predicate Devices
- Ultrasound Scanner Pro Focus 2202 (K043524)
Related Devices
- K123254 — ULTRASOUND SCANNER FLEX FOCUS · B-K Medical Aps · Feb 13, 2013
- K100919 — PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202 · B-K Medical Aps · Dec 16, 2011
- K132335 — ULTRASOUND SCANNER FLEX FOCUS 1202 · B-K Medical Aps · Jan 10, 2014
- K132677 — ULTRASOUND SCANNER FLEX FOCUS 1202 · B-K Medical Aps · Jan 7, 2014
- K043554 — ULTRASOUND SCANNER MINI FOCUS, MODEL 1402 · B-K Medical A/S · Jan 14, 2005
Submission Summary (Full Text)
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# 510(k) Summary:
K081154
MAY 2 3 2008
This summary is provided as part of this Premarket Notification in compliance with 2 Section 807.92.
Submitters name: B-K Medical Address: Mileparken 34, DK2730 Herlev, Denmark Phone: +45 44528100 Fax: +45 44528199 Contact person: Jens Rasmussen, Director of Quality Date prepared: 17 April, 2008
Trade name: Ultrasound Scanner Flex Focus 1202 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 Pro Focus 2202, K043524
## Device description:
Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode.
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.
An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
## Transducers
Transducers are linear arrays, convex arrays, phased arrays and mechanical sector. The patient contact materials are biocompatible. All transducers used together with Flex Focus 1202 are Track 3 transducers.
## Acoustic output
The system controlling the Acoustic Output in Flex Focus 1202 is the same as the system in Pro Focus 2200. The system will assure that the acoustic output always will stay below the preamendments 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 Flex Focus 1202 has been tested by a recognized Certified Body.
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Image /page/1/Picture/0 description: The image shows handwritten text. The text at the top reads "KO 81154". Below that, the text reads "pg. 2 of 2".
## Acoustic Output Reporting
The Acoustic Output Reporting is made according to the standards required by "Inf Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 30, 1997"
## Intended use.
1202 intended uses are contained within 2202-intended uses:
| | Cleared, unmodified device,<br>Ultrasound scanner Pro Focus 2202,<br>K043524 | Modified device, Ultrasound scanner Flex Focus 1202 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Modes of operation | B, M, PWD, CFM 1) and<br>combinations.<br>Tissue harmonic and contrast<br>harmonic imaging | B, M, PWD,CFM 1) and<br>combinations.<br>Tissue harmonic imaging |
| Intended use(clinical application) | Abdominal<br>Cardiac<br>Fetal (incl Obstetrics)<br>Intraoperative<br>Transurethral<br>Neurosurgery<br>Pediatrics<br>Transrectal<br>Small Parts (organs)<br>Transvaginal<br>Peripheral vascular<br>Musculo-skeletal | Abdominal<br>Cardiac<br>Fetal (incl Obstetrics)<br>Intraoperative<br>Transurethral<br>Neurosurgery<br>Pediatrics<br>Transrectal<br>Small Parts (organs)<br>Transvaginal<br>Peripheral vascular<br>Musculo-skeletal |
1) CFM= Color Flow Mapping=Color Doppler and Amplitude (Power) 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 scanconverter, modified transmitter, modified beamformer, modified mechanical outline.
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or waves, arranged in a cascading manner.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
· MAY 2 3 2008
Mr. Jens Rasmussen Director of Quality B-K Medical ApS Mileparken 34, DK 2730 Herlev DENMARK
Re: K081154
Trade/Device Name: Ultrasound Scanner Flex Focus 1202 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYN. IYO and ITX Dated: April 17, 2008 Received: April 23, 2008
Dear Mr. Rasmussen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Ultrasound Scanner Flex Focus 1202, as described in your premarket notification:
Transducer Model Number
1850 (with interchangeable probes 8539, 6004, 6005)
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If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains 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 prominently marked "ADD-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 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
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Page 3 - Mr. Rasmussen
If you have any questions regarding the content of this letter, please contact Paul Hardy at (240) 276-3666.
Sincerely yours,
Vopu M Whang
ಳ Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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#### Diagnostic Ultrasound Indications for Use Form
#### System: 1202
#### 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) | Continous<br>Wave) | |
| 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 | | P | P | P | P | P | P | | P | | |
| 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 | | P | P | P | P | P | P | | P | | |
| 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) | | | | | | | | | | | |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | | | | |
| Additional Comments: 1} B+M, B+D, B+C, B+D+C. | | | | | | | | | | | |
| | | | | | | | D is PWD, C is Color 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)
tony m. Pham
uctive. Abdominal and
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1202 System: 1850_(with interchangeable probes_8539,6004,6005) 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 Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | P | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | P | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| 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: Intraoperative: Rectum, Urethra, Urinary bladder,
(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
Tony M. Whg
Division of Reproductive, Abdominal and Radiological 510(k) Number
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| System: | 1202 |
|-------------|------|
| Transducer: | 8661 |
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>Doppler |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | 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 | P | P | P | | P | P 1) | 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 *Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging
B+M, B+D, B+C, B+D+C. (D is PWD, C is Additional Comments:_ _1))Mode combinations: 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
Lona Th. Witz
(Divis ductive. Abdomina Division of Re Radiological Devices 510(k) Number
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1202_ System: 8662 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 Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color Doppler | Combined<br>(Specify 1) | Amplitude<br>Doppler |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify 2) | P | P | P | | P | P | P |
| | Intra-operative (Neuro) | P | P | P | | P | P | P |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | P | P | P | | P | P | 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 Adult | | | | | | | |
| 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
1) Mode combinations: B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow Additional Comments: mapping Doppler including Amplitude(power)Doppler)_ 2)Intraoperative: Gall bladder
(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
Lorge 7. Whz
(Division Sin Division of Reproductive, Abdominal Radiological Device 510(k) Number
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_1202 System: 8811 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 Only) | Specific<br>(Tracks I & III) | B | M | PWD | Harm<br>onic<br>imagin<br>g | Color<br>Doppler | Combined<br>(Specify 1) | Amplitude<br>Doppler |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify 2) | P | P | P | P | P | P | P |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (Specify 3) | P | P | P | P | P | P | P |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Conventional) | P | P | P | P | P | P | P |
| | Musculo-skel. (Superficial) | P | P | P | P | P | P | P |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | P | 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: 2)Intraoperative: Breast, liver, pancreas, billiary system
3)Small Organ: Breast, testis, penis, 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 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)
Lorry M. Witz
(Division/S
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1202__________________________________________________________________________________________________________________________________________________________________________ System: 8820e 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 Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Amplitude<br>Doppler |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal 2) | P | P | P | | P | P 1) | P |
| | Abdominal 2) | 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 | 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 *Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging
1))Mode combinations: B+M, B+D, B+C, B+D+C. (D is PWD, C is Additional Comments:_ Color Flow mapping Doppler including Amplitude(power)Doppler)_ 2) includes 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)
Aorgue Th. Wtz
ductive. Abdomin 510(k) N
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| ranedlicar | 0000<br>Call Children Land La March &<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 1<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 | CWD | Color<br>Doppler | Combined<br>(Specify) | Amplitude<br>Doppler |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | | | | | | | |
| | 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 | P | P | P | | P | P 1) | P |
| | 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
B+M, B+D, B+C, B+D+C. (D is PWD, C is Additional Comments:__________________________________________________________________________________________________________________________________________________________ _1))Mode combinations: 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)
hospitn 22
(Division Division of Reproductive, Abdominal a Radiological De 510(k) Number
