(64 days)
The SuperSonic Imagine AIXPLORER® ultrasound system and transducer are intended for general purpose pulse echo ultrasound imaging, Doppler fluid flow analysis of the human body, and tissue elasticity imaging of soft tissues.
The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, GYN, Pelvic, Pediatric, Urology, Trans-vaginal and Neonatal Cephalic.
The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal Cephalic).
The SuperSonic Imagine AIXPLORER® system is a cart based ultrasound imaging system used to perform invasive and non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, curved, microconvex, and motorized linear array transducers to produce images, which are displayed on a LCD monitor. An adjustable control panel with integrated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the user to perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system functions in a manner identical to the predicate devices and transducers for the imaging modes: B-Mode, Color Flow, Pulsed Wave Doppler, Harmonic Imaging, Amplitude Doppler, 3D imaging, Panoramic Imaging and for ShearWave™ elastography. The addition of the quantification tool allows the user to read the average shear wave propagation speed.
Here's a summary of the acceptance criteria and study information for the Aixplorer® Diagnostic Ultrasound System (K132274), based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Shear Wave Speed Bias | Derived as the difference between the mean of five independent SWE shear wave speed measurements and the nominal shear wave speed, normalized by the nominal shear wave speed and expressed as a percentage. Specific percentage not provided, but generally expected to be low to indicate accuracy. |
| Shear Wave Speed Precision | Derived as the standard deviation of five independent SWE shear wave speed measurements normalized by the mean of the five independent SWE measurements, and expressed as a percentage. Specific percentage not provided, but generally expected to be low to indicate reproducibility. |
| QBox Measurement Accuracy (vs. Matlab) | The comparison between the SWE QBox/ROI measurements performed by the Aixplorer versus the results obtained by performing the same measurements in Matlab were within 5%. |
| Acoustic Output Limits | Complies with FDA guideline limits (September 9, 2008, 510(k) diagnostic ultrasound guidance) and NEMA UD 3 (2004), NEMA UD 2 (2004). - Mechanical Index: 1.9 (Maximum) - TIS/TIB: 0.1 - 4.0 (Range) - ISPTA(d): 720 mW/cm2 - ISPPA(d): 0 - 700 W/cm2 (Limits are the same as predicate Track 3 devices.) |
| General Safety and Electrical Standards | Designed to comply with IEC 60101 -1 (2005), IEC 60601-2-37 (2007), and IEC 60601-1-2 (2000). |
Study Information
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Shear Wave Speed Tests: Four different cylindrical target types of a CIRS 049A Elasticity Quality Assurance phantom were used. For each target, five independent SWE shear wave speed measurements were taken. (Total of 20 measurements).
- Sample Size for QBox Measurement Tests: Not explicitly stated as a number of samples, but presumably refers to measurements performed on the same phantom targets or similar controlled environments as the shear wave speed tests.
- Data Provenance: The tests were "non clinical testing performed on the modified Aixplorer." This indicates prospective bench testing using a phantom. There is no information regarding country of origin for this test data beyond the manufacturer being in France.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- The ground truth for the test set was established using a CIRS 049A Elasticity Quality Assurance phantom, which has "nominal shear wave speeds" for its targets, implying a pre-defined or manufacturer-provided ground truth.
- For the QBox Measurement Tests, the comparison was against "results obtained by performing the same measurements in Matlab." This suggests the ground truth was derived from a computational standard, not expert consensus.
- Therefore, no human experts were involved in establishing the ground truth for these non-clinical performance tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- No human adjudication method was used, as the study was a non-clinical, phantom-based bench test comparing device measurements to known phantom properties or computational results (Matlab).
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
- No MRMC comparative effectiveness study was done. This 510(k) summary focuses on the technical performance and safety of the ultrasound system itself, not on the improvement of human readers with AI assistance. The "AI" component mentioned (ShearWave™ elastography, quantification tool) is integrated into the device's imaging and measurement capabilities rather than being a separate AI-based diagnostic aid for human review.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the non-clinical performance data represents "standalone" algorithm performance in controlled bench tests. The tests assessed the device's ability to accurately measure shear wave speed and QBox values independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The primary type of ground truth used was phantom-based nominal values (for shear wave speed) and computational standards (comparison to Matlab for QBox measurements).
8. The sample size for the training set
- This document describes non-clinical performance testing for a diagnostic ultrasound system. It does not mention any "training set" as it would for a machine learning or AI algorithm in the typical sense of needing data to learn from. The device's "AI" functionalities (ShearWave™ elastography) are inherent in its design and physics-based measurements rather than being trained on a dataset.
9. How the ground truth for the training set was established
- As no training set is mentioned or implied for this device's submission, this question is not applicable based on the provided text.
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K132274
Page 1 of 4
510(k) Summary of Safety and Effectiveness Aixplorer® Diagnostic Ultrasound System
This summary of safety and effectiveness information is submitted in accordance with 21 CFR $807.92.
1) Submitter's name, address, telephone number, contact person
Submitted by: SuperSonic Imagine, S.A. Les Jardins de la Duranne - Bât. E & F 510, rue René Descartes 13857 Aix-en-Provence Cedex France
SEP 2 4 2013
Aurelie Gruener, Sr. Manager, Regulatory Affairs
Tel: 011 33 442 99 24 39 Fax: 011 33 442 52 59 21
-
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
| Common/Usual Name: | Diagnostic Ultrasound System with Accessories |
|---|---|
| Proprietary Name: | Aixplorer® |
. Classification: Regulatory Class: II
| Classification Name: | 21 CFRSection | Product Code |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
3) Substantially Equivalent/Predicate Device
AIXPLORER® Ultrasound Imaging Systems (K112255 cleared on 08/28/2013 and K121329 cleared on 08/24/2013).
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4) Description of Device
The SuperSonic Imagine AIXPLORER® system is a cart based ultrasound imaging system used to perform invasive and non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, curved, microconvex, and motorized linear array transducers to produce images, which are displayed on a LCD monitor. An adjustable control panel with integrated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the user to perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system functions in a manner identical to the predicate devices and transducers for the imaging modes: B-Mode, Color Flow, Pulsed Wave Doppler, Harmonic Imaging, Amplitude Doppler, 3D imaging, Panoramic Imaging and for ShearWave™ elastography. The addition of the quantification tool allows the user to read the average shear wave propagation speed.
5) Intended Use
The SuperSonic Imagine AIXPLORER® ultrasound system and transducer are intended for general purpose pulse echo ultrasound imaging, Doppler fluid flow analysis of the human body, and tissue elasticity imaging of soft tissues.
6) Safety Considerations
As a Track 3 ultrasound device, the SuperSonic Imagine AIXPLORER® ultrasound system is designed to comply with the NEMA UD 3 (2004), Standard For Real Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment, and NEMA UD 2 (2004), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
With respect to limits on acoustic outputs, the SuperSonic Imagine AIXPLORER® ultrasound system complies with the FDA guideline limits set in the September 9, 2008, 510(k) diagnostic ultrasound guidance.
With regard to general safety, the SuperSonic Imagine AIXPLORER® ultrasound system is designed to comply with IEC 60101 -1 (2005) Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance. IEC 60601 - 2-37 (2007): Particular Requirements For The Safety Of Ultrasonic Medical Diagnostic And Monitoring Equipment and IEC 60601-1-2 (2000) Medical Electrical Equipment - part 1-2, General Requirements for Safety - Collateral Standard Electromagnetic Compatibility.
| Mechanical Index | 1.9 (Maximum) | |
|---|---|---|
| TIS/TIB | - | 0.1 - 4.0 (Range) |
| ISPTA (d) | 720 mW/cm2 | |
| ISPPA (d) | 0 - 700 W/cm2 |
The device's acoustic output limits are:
The limits are the same as predicate Track 3 devices. These considerations apply to all modes the system offers.
{2}------------------------------------------------
7) Comparison to Predicate Devices
The SuperSonic Imagine AIXPLORER® system is substantially equivalent to the predicate device with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.
- The systems are both intended for diagnostic ultrasound imaging and fluid flow . analysis.
- . The systems have the same clinical intended use.
- The systems have the same B-Mode (grayscale imaging) and Doppler capabilities. .
- The systems: have the same adjustable numeric scale next to the color bar, for . ShearWave™ Elastography.
- . The systems have similar capability in terms of harmonic imaging, spatial compound imaging, elastography imaging and other image post-processing features to improve the image quality and aid in clinical evaluation and diagnosis.
- . The transducers are similar in materials, manufacture and clinical capability.
- . The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
- . The systems have acoustic power levels which are below the applicable FDA limits.
- . The systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
- . The systems have been found to be manufactured in compliance with approved electrical and physical safety standards.
- . In addition to the adjustable SWE numeric scale, the new device has the functionality that enables the user to place a region of interest (ROI) (also referred to as QBox) within the image and read the average shear wave propagation speed, plus the minimum, maximum and variance of the distribution of shear wave propagation speed values within the ROI. With this functionality, the user could appreciate quantitatively differences in shear wave propagation speeds between different structures. With the new device, the labeling for the adjustable SWE numeric scale as well as the SWE ROI quantification values shall be in kPa or m/s.
8) Non Clinical Performance Data/Bench Tests
The following non clinincal testing was performed on the modified Aixplorer to ensure continued safety and effectiveness:
- . Shear wave speed Bias and Precision Tests -
SWE estimation bias and precision measurements were made using four different cylindrical target types of a CIRS 049A Elasticity Quality Assurance phantom (nominal shear wave speeds between 1.6 and 5.2 m/s). These measurements were made for all of the transducers listed in the K112255 510(k).
Estimation bias was derived as the difference between the mean of five independent SWE shear wave speed measurements and the nominal shear wave speed, normalized by the nominal shear wave speed and expressed as a percentage.
SUPERSONIC IMAGINE
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K132274
Page 4 of 4
SWE estimation precision was derived as the standard deviation of five independent SWE shear wave speed measurements normalized by the mean of the five independent SWE measurements, and expressed as a percentage.
- QBox Measurement Tests -
These tests demonstrated that the comparison between the SWE QBox/ROI measurements performed by the Aixplorer vs the results obtained by performing the same measurements in Matlab were within 5%.
9) Conclusion
The SuperSonic Imagine AIXPLORER® system is substantially equivalent to the predicate devices in safety and effectiveness. This is demonstrated by:
- There are no new questions of safety and effectiveness concerning the SuperSonic . Imagine AIXPLORER® ultrasound system and transducers.
- . The system and predicate devices are intended for general purpose pulse echo ultrasound imaging, Doppler fluid flow analysis of the human body, and tissue elasticity imaging of soft tissues.
- . The system and predicate devices have been designed, manufactured and tested to the same electrical and physical safety standards.
- . The system's and predicate devices' acoustic power levels are below the applicable FDA limits.
- . The effectiveness of the new device was demonstrated in the non clinical testing conducted by SSI.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved lines that resemble a human figure or a symbol representing health and well-being.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 24, 2013
SuperSonic Imagine, S.A. % Mr. Jacques Souquet Les Jardins de la Duranne 510 Rue René Descartes - Bât. E et F Aix -en-Provence Cedex 13 857 FRANCE
Re: K132274 Trade/Device Name: Aixplorer® Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: 1YN, IYO. ITX Dated: August 27, 2013 Received: September 6, 2013
Dear Mr. Souquet:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading,
This determination of substantial equivalence applies to the following transducers intended for use with the Aixplorer . as described in your premarket notification:
Transducer Model Numbers
SL15-4 SC6-1
SE12-3 SLVI6-S SL10-2 SMC12-3
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Page 2-Mr. Souquet
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Smh7)
for
Janine M. Morris Director. Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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510(k) number: K132274
Device Name: AIXPLORER® Ultrasound System
Indications for Use:
The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, GYN, Pelvic, Pediatric, Urology, Trans-vaginal and Neonatal Cephalic.
The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal Cephalic).
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
Smh7)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K132274 - -
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510(k) number: K132274
Device Name: AIXPLORER® Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging &Other | Fetal | |||||||
| Abdominal (including urolology) | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9, 10 | |||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9, 10 | |||
| Small Organ (Breast, Thyroid,Testicle, Prostate, penis, etc...) | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9, 10 | |||
| Neonatal Cephalic | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 9 | |||
| Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8 | |||
| Trans-vaginal | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8 | |||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9, 10 | |||
| Musculo-skeletal (Superficial) | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9, 10 | |||
| Intravascular | ||||||||
| GYN | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 10 | |||
| Pelvic | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 10 | |||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9, 10 | ||
| Other (Specify) | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 |
Additional Comments:
| 1: Combined modes include: B+ Color Flow | 2: Combined modes include: B+ ShearWaveTM Elastography |
|---|---|
| 3: Combined modes include: B+ Pulsed Wave | 4: Combined modes include: B+ Pulsed Wave + Color Flow |
| 5: Harmonic Imaging | 6: Spatial Compounding |
| 7: ShearWaveTM Elastography | 8: Imaging Guidance for Biopsies |
| 9: Panoramic Imaging | 10: 3D Imaging |
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
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510(k) Number : K132274
Device Name: SL15-4 transducer (1D Linear Array Transducer)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging &Other | Fetal | |||||||
| Abdominal | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 | ||
| Small Organ (for example Breast,Thyroid, Testicle, Prostate, Penis) | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 | ||
| Neonatal Cephalic | P | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 9 | ||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 | ||
| Intravascular | ||||||||
| GYN | ||||||||
| Pelvic | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 | |
| Other (Specify) |
Additional Comments:
| 1: Combined modes include: B+ Color Flow | 2: Combined modes include: B+ ShearWaveTM Elastography |
|---|---|
| 3: Combined modes include: B+ Pulsed Wave | 4: Combined modes include: B+ Pulsed Wave + Color Flow |
| 5: Harmonic Imaging | 6: Spatial Compounding |
| 7: ShearWaveTM Elastography | 8: Imaging Guidance for Biopsies |
| 9: Panoramic Imaging | 10: 3D Imaging |
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
{9}------------------------------------------------
510(k) Number : K132274
Device Name: SC6-1 transducer (curved array transducer)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | MPWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | ||||||
| Fetal Imaging &Other | Fetal | ||||||
| Abdominal (including urolology) | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 | |
| Intra-operative (Specify) | |||||||
| Intra-operative (Neuro) | |||||||
| Laparoscopic | |||||||
| Pediatric | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 | |
| Small Organ (Breast, Thyroid, Testicle,Prostate, penis, etc...) | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 | |
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 | |
| Musculo-skeletal (Superficial) | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 | |
| Intravascular | |||||||
| GYN | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 | |
| Pelvic | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 | |
| Other (Specify) | |||||||
| Cardiac | Cardiac Adult | ||||||
| Cardiac Pediatric | |||||||
| Intravascular (Cardiac) | |||||||
| Trans-esoph. (Cardiac) | |||||||
| Intra-cardiac | |||||||
| Other (Specify) | |||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 |
| Other (Specify) | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 |
Additional Comments
| 1: Combined modes include: B+ Color Flow | 2: Combined modes include: B+ ShearWaveTM Elastography |
|---|---|
| 3: Combined modes include: B+ Pulsed Wave | 4: Combined modes include: B+ Pulsed Wave + Color Flow |
| 5: Harmonic Imaging | 6: Spatial Compounding |
| 7: ShearWaveTM Elastography | 8: Imaging Guidance for Biopsies |
| 9: Panoramic Imaging | 10: 3D Imaging |
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)
{10}------------------------------------------------
510(k) Number : K132274
Device Name: SE12-3 transducer (endocavitary transducer)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | MPWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | ||||||
| Fetal Imaging &Other | Fetal | ||||||
| Abdominal | |||||||
| Intra-operative (Specify) | |||||||
| Intra-operative (Neuro) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...) | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 | ||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 | ||
| Trans-vaginal | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 | ||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skeletal (Conventional) | |||||||
| Musculo-skeletal (Superficial) | |||||||
| Intravascular | |||||||
| GYN | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 | ||
| Pelvic | P | P | P | P 1. 2, 3, 4 | P 5, 6, 7, 8 | ||
| Other (Specify) | |||||||
| Cardiac | Cardiac Adult | ||||||
| Cardiac Pediatric | |||||||
| Intravascular (Cardiac) | |||||||
| Trans-esoph. (Cardiac) | |||||||
| Intra-cardiac | |||||||
| Other (Specify) | |||||||
| PeripheralVessel | Peripheral vessel | ||||||
| Other (Specify) | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 |
Additional Comments:
| 1: Combined modes include: B+ Color Flow | 2: Combined modes include: B+ ShearWave™ Elastography |
|---|---|
| 3: Combined modes include: B+ Pulsed Wave | 4: Combined modes include: B+ Pulsed Wave + Color Flow |
| 5: Harmonic Imaging | 6: Spatial Compounding |
| 7: ShearWave™ Elastography | 8: Imaging Guidance for Biopsies |
| 9: Panoramic Imaging | 10: 3D Imaging |
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
Page 5 of 8
{11}------------------------------------------------
510(k) Number : K132274
Device Name: SLV16-5 transducer (motorized linear transducer)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other* (Specify) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging &Other | Fetal | ||||||||
| Abdominal | P | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 10 | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 10 | ||
| Small Organ (for example Breast,Thyroid, Testicle, Prostate, penis,etc...) | P | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 10 | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 10 | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 10 | ||
| Intravascular | |||||||||
| GYN | |||||||||
| Pelvic | |||||||||
| Other (Specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 10 | |
| Other (Specify) |
N = new indication; P = previously cleared by FDA (K121329)
Additional Comments:
| 1: Combined modes include: B+ Color Flow | 2: Combined modes include: B+ ShearWaveTM Elastography |
|---|---|
| 3: Combined modes include: B+ Pulsed Wave | 4: Combined modes include: B+ Pulsed Wave + Color Flow |
| 5: Harmonic Imaging | 6: Spatial Compounding |
| 7: ShearWaveTM Elastography | 8: Imaging Guidance for Biopsies |
| 9: Panoramic Imaging | 10: 3D Imaging |
.
.
Prescription Use _X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
{12}------------------------------------------------
510(k) Number : K132274
Device Name: SL10-2 transducer (linear transducer)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 | |||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 | |||
| Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...) | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 | |||
| Neonatal Cephalic | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 9 | |||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 | |||
| Musculo-skeletal (Superficial) | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 | |||
| Intravascular | ||||||||
| GYN | ||||||||
| Pelvic | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 | ||
| Other (Specify) | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 | |||
| N = new indication: P = previously cleared by FDA (K131330) |
Additional Comments:
| 1: Combined modes include: B+ Color Flow | 2: Combined modes include: B+ ShearWave™ Elastography |
|---|---|
| 3: Combined modes include: B+ Pulsed Wave | 4: Combined modes include: B+ Pulsed Wave + Color Flow |
| 5: Harmonic Imaging | 6: Spatial Compounding |
| 7: ShearWave™ Elastography | 8: Imaging Guidance for Biopsies |
| 9: Panoramic Imaging | 10: 3D Imaging |
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)
{13}------------------------------------------------
510{k} Number : K132274
Device Name: SMC12-3 transducer (micro-curved transducer)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other* (Specify) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging | Fetal | ||||||||
| & Other | Abdominal | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 | |||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 | ||||
| Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...) | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 | ||||
| Neonatal Cephalic | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7 | ||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 | ||||
| Musculo-skeletal (Superficial) | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 | ||||
| Intravascular | |||||||||
| GYN | |||||||||
| Pelvic | |||||||||
| Other (Specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 | |||
| Vessel | Other (Specify) | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 | |||
| N = new indication; P = previously cleared by FDA (K121329) |
Additional Comments:
| 1: Combined modes include: B+ Color Flow | 2: Combined modes include: B+ ShearWave™ Elastography |
|---|---|
| 3: Combined modes include: B+ Pulsed Wave | 4: Combined modes include: B+ Pulsed Wave + Color Flow |
| 5: Harmonic Imaging | 6: Spatial Compounding |
| 7: ShearWave™ Elastography | 8: Imaging Guidance for Biopsies |
| 9: Panoramic Imaging | 10: 3D Imaging |
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
Page 8 of 8
§ 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.