(114 days)
The diagnostic ultrasound system (U50) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), transvaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
The U50 is a portable Diagnostic Ultrasound System, which applies advanced technologies such as Phased Inversion Harmonic Compound Imaging (eHCI), Multi-Beam-Forming (mBeam), Speckle Resistance Imaging (eSRI), and Spatial Compounding Imaging, etc. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in B-mode, M-mode, PW-mode, Color-mode, PDI/DPDI mode. This system provides a series of probes that include linear array, convex array, micro-convex array with a frequency range of approximately 2.5 MHz to 11 MHz.
This document is a 510(k) summary for the Edan Instruments, Inc. U50 Diagnostic Ultrasound System. It details the device's intended use and compares it to predicate devices to establish substantial equivalence.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria (e.g., specific accuracy, sensitivity, or specificity thresholds). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The "reported device performance" is implicitly that the device performs equivalently to the listed predicate devices in terms of its intended use, design, performance effectiveness, and safety.
Since the document doesn't provide specific numerical performance metrics, a table summarizing them as requested cannot be created. The "performance" is implicitly deemed acceptable because it meets the standards of the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Clinical testing is not required." This indicates that no clinical test set was used for this submission. The evaluation was based on non-clinical testing and comparison to existing predicate devices. Consequently, there is no data provenance (e.g., country of origin, retrospective/prospective) for a clinical test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical testing was performed and thus no clinical test set was used, no experts were used to establish ground truth for a test set. The determination of substantial equivalence relies on non-clinical data and regulatory comparison.
4. Adjudication Method for the Test Set
As no clinical test set was used, there was no adjudication method for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done. The submission explicitly states "Clinical testing is not required."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a diagnostic ultrasound system, which inherently involves a human operator to acquire and interpret images. It is not an AI algorithm that functions in a standalone manner without human-in-the-loop performance. Therefore, no standalone algorithm-only performance study was conducted or is applicable in this context. The "performance effectiveness" is evaluated in the context of the complete system, including human operation.
7. The Type of Ground Truth Used
Given that clinical testing was not required for this 510(k) submission, there was no clinical ground truth established or used in the way typically seen in AI/CAD device submissions (e.g., pathology, expert consensus, outcomes data). The "ground truth" for the device's acceptable performance is its compliance with recognized safety standards and its demonstrated substantial equivalence to predicate ultrasound devices through non-clinical testing.
8. The Sample Size for the Training Set
This document does not describe the development of an AI algorithm or a training set for machine learning. The device is a traditional diagnostic ultrasound system. Therefore, there is no training set sample size described in this submission.
9. How the Ground Truth for the Training Set Was Established
Since no training set for an AI algorithm is mentioned, there is no information on how ground truth for a training set was established.
Summary of the Study:
The study proving the device meets acceptance criteria is a 510(k) Pre-market Notification submission, not a clinical trial. The acceptance criteria are based on demonstrating substantial equivalence to predicate devices. This is achieved through:
- Non-clinical testing: This includes electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), acoustic output testing (per FDA guidelines), and biocompatibility (ISO 10993-1, -5, -10). The document does not provide specific results or acceptance values for these tests, only that they were conducted according to the standards.
- Comparison to predicate devices: The submission asserts that the U50 Diagnostic Ultrasound System has the "same intended use, similar product design, same performance effectiveness, performance safety and the same needle-guide bracket material, property, and sterilization methods as the predicate devices." The differences are stated to "not affect the basic design principle, usage, effectiveness and safety of the subject device."
The FDA's letter (K123249) confirms that the device was deemed "substantially equivalent" to legally marketed predicate devices, thereby meeting the regulatory acceptance criteria for market clearance. This clearance specifically applies to the U50 system and a list of associated transducers for a wide range of clinical applications in B-mode, M-mode, PW-mode, Color-mode, and PDI/DPDI mode, including biopsy guidance and harmonic imaging.
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Section 5 - 510(k) Summary FEB 8 2013
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc.3/F-B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou,Nanshan Shenzhen, 518067 P.R. ChinaTel.: (0755) 26856469Fax: (0755) 26882223 |
|---|---|
| Contact Person: | Randy Jiang |
| Prepare date: | Sep 25, 2012 |
| 2. Device nameand classification: | Device Name:Diagnostic Ultrasound System, Model U50Classification Name:892.1550 System, Imaging, Pulsed Doppler, UltrasonicProduct code: IYN892.1560 Ultrasonic, Pulsed echo, ImagingProduct code: IYO892.1570 Transducer, Ultrasonic, DiagnosticProduct code: ITXRegulatory Class: Class II |
- Predicate Device:
DUS 60 Digital Ultrasonic Diagnostic Imaging System / K110999 / Edan Instruments, Inc.
DC-6 Diagnostic Ultrasound System / K072164 / Shenzhen Mindray Bio-medical Electronics Co., Ltd.
M5 Diagnostic Ultrasound System / K102991 / Shenzhen Mindray Bio-medical Electronics Co., Ltd.
GE LOGIQ E9 Diagnostic Ultrasound System/ K082185/ General Electric Co.
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| 4. DeviceDescription: | The U50 is a portable Diagnostic Ultrasound System, which appliesadvanced technologies such as Phased Inversion Harmonic CompoundImaging (eHCI), Multi-Beam-Forming (mBeam), Speckle ResistanceImaging (eSRI), and Spatial Compounding Imaging, etc. Various imageparameter adjustments, 12.1 inch LCD and diverse probes areconfigured to provide clear and stable images. |
|---|---|
| Its function is to acquire and display Ultrasound images in B-mode,M-mode, PW-mode, Color-mode, PDI/DPDI mode. This systemprovides a series of probes that include linear array, convex array,micro-convex array with a frequency range of approximately 2.5 MHzto 11 MHz. | |
| 5. Intended Use: | The diagnostic ultrasound system (U50) is applicable for adults,pregnant women, pediatric patients' ultrasound evaluation in hospitalsand clinics. It is intended for use in abdominal, obstetrics, gynecology, |
pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), transvaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
6. Effectiveness and Safety Considerations:
Clinical test:
Clinical testing is not required.
Non-clinical test:
The following safety standards are conducted on the subject device:
(1) IEC 60601-1 Electrical Safety
(2) IEC 60601-1-2 Electromagnetic Compatibility
(3) Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.
(4) ISO 10993-1, ISO 10993-5 and ISO 10993-10
7.Comparison to the predicate device
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety and the same needle-guide bracket material, property, and sterilization methods as the predicate devices.
The differences above between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.
8. Substantially Equivalent Determination
Verification and validation testing was conducted on the U50 Diagnostic Ultrasonic System.
5-2
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This premarket notification submission demonstrates that U50 Diagnostic Ultrasonic System is substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
February 8, 2013
Edan Instruments, Inc. c/o Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories 333 Pfingsten Rd. NORTHBROOK IL 60062
Re: K123249
Trade/Device Name: U50 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: January 17, 2013 Received: January 30, 2013
Dear Mr. Devine:
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.
This determination of substantial equivalence applies to the following transducers intended for use with the U50 Diagnostic Ultrasound System, as described in your premarket notification:
| Transducer Model NumberE | |
|---|---|
| --------------------------------------------------------------------------------- |
| C352UB | E612UB | C422UB |
|---|---|---|
| L1042UB | C612UB | L552UB |
| L742UB | C6152UB |
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Page 2 - Mr. Devine
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/Safety/ReportalProblem/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/cdrh/industry/support/index.html.
Sincerely yours,
Sean M. Boyd -S 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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Diagnostic Ultrasound System 510K Submission
Indications for Use
510(k) Number (if known):
Device Name: U50 Diagnostic Ultrasound System
Intended Use:
The diagnostic ultrasound system (U50) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vasculoskeletal (conventional and superficial), transvaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
Prescription Use
(21 CFR Part 801 Subpart D) ·
Or Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
(Division Sign Off)
Division of Radlotogical Health
Office of In Vitre Diagnostics and Re
510(k) K123219
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U50 Diagnostic Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined (Specify) | Other (Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | N | N | N | N | N | Note 1,2 | ||
| Abdominal | N | N | N | N | N | Note 1,2 | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | Note 1,2 | ||
| Small Organ (Specify) * | N | N | N | N | N | Note 1,2 | ||
| FetalImaging& Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | N | N | N | N | N | Note 1,2 | ||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | Note 1,2 | ||
| Musculo-skeletal (Superficial) | N | N | N | N | N | Note 1,2 | ||
| Intravascular | ||||||||
| Other (Specify) ** | N | N | N | N | N | Note 1,2 | ||
| Cardiac | Adult Cardiac | N | N | N | N | N | Note 1,2 | |
| Pediatric Cardiac | N | N | N | N | N | Note 1,2 | ||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheralvascular | Peripheral vascular | N | N | N | N | N | Note 1,2 | |
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDVDPDI, B+Color+PW, B+PDV/DPDI +PW
- Small Organ includes Thyroid, Testes, Breast
** Other use includes Urology, Kidney, Gynecology
Note 1: Biopsy Guidance
Note 2: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostic and Radiological Health
510(k) K123249
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U50 with C352UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined(Specify) | Other(Specify) | |
| Ophthalmic | Ophthalmic | Ophthalmic | |||||||
| FetalImaging& Other | Fetal / Obstetrics | N | N | N | N | N | Note 1,2 | ||
| Abdominal | N | N | N | N | N | Note 1,2 | |||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro logical) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) * | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) ** | N | N | N | N | N | Note 1,2 | |||
| Cardiac | Adult Cardiac | ||||||||
| Cardiac | Pediatric Cardiac | ||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra- cardiac | |||||||||
| Peripheralvascular | Peripheral vascular | ||||||||
| vascular | Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+Color+PW, B+Color+PW, B+PDV/DPDI +PW
- Small Organ includes Thyroid, Testes, Breast
** Other use includes Urology, Kidney, Gynecology
Note 1: Biopsy Guidance
Note 2: Harmonic Imaging, This feature does not use contrast agent.
(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)
11
(División Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostic and Radiological Health
510(k) K123249
{8}------------------------------------------------
U50 with L1042UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined(Specify) | Other(Specify) | |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging& Other | Fetal / Obstetrics | ||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro logical) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) * | N | N | N | N | N | Note 1,2 | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | Note 1,2 | |||
| Musculo-skeletal (Superficial) | N | N | N | N | N | Note 1,2 | |||
| Intravascular | |||||||||
| Other (Specify) ** | |||||||||
| Cardiac | Adult Cardiac | ||||||||
| Pediatric Cardiac | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra- cardiac | |||||||||
| Peripheralvascular | Peripheral vascular | N | N | N | N | N | Note 1,2 | ||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDVDPDI, B+Color+PW, B+PDI/DPDI +PW
- Small Organ includes Thyroid, Testes, Breast
** Other use includes Urology, Kidney, Gynecology_ ___________________________________________________________________________________________________________________________
Note 1: Biopsy Guidance
Note 2: Harmonic Imaging, This feature does not use contrast agent.
(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)
$
(División Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)________________________________________________________________________________________________________________________________________________________________________
{9}------------------------------------------------
U50 with L742UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | N | N | N | N | N | N | Note 1,2 | |
| Fetal | Neonatal Cephalic | |||||||
| Imaging | Adult Cephalic | |||||||
| & Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | Note 1,2 | |
| Musculo-skeletal (Superficial) | N | N | N | N | N | N | Note 1,2 | |
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Adult Cardiac | ||||||||
| Pediatric Cardiac | ||||||||
| Cardiac | Intravascular(Cardiac) | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | N | N | N | N | N | N | Note 1,2 |
| vascular | Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDVDPDI, B+Color+PW, B+PDVDPDI +PW
- Small Organ includes Thyroid, Testes, Breast
** Other use includes Urology, Kidney, Gynecology
Note 1: Biopsy Guidance -
Note 2: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostic and Radiological Health
510(k) K123249
{10}------------------------------------------------
U50 with E612UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PW | CW | Color | Combined (Specify) | Other (Specify) | ||
| General | Specific | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | ||||||||
| FetalImaging& Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | N | N | N | N | N | Note 1,2 | ||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Adult Cardiac | ||||||||
| Pediatric Cardiac | ||||||||
| Cardiac | Intravascular(Cardiac) | |||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral vascular | Peripheral vascular | |||||||
| vascular | Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+Color+PW, B+Color+PW, B+PDVDPDI +PW
- Small Organ includes Thyroid, Testes, Breast
** Other use includes Urology, Kidney, Gynecology
Note 1: Biopsy Guidance
Note 2: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostic and Radiological Health
510(k) K123249
{11}------------------------------------------------
U50 with C612UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined(Specify) | Other(Specify) | |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging& Other | Fetal / Obstetrics | ||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro logical) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | Note 1,2 | |||
| Small Organ (Specify) * | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) ** | |||||||||
| Cardiac | Adult Cardiac | ||||||||
| Pediatric Cardiac | N | N | N | N | N | Note 1,2 | |||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra- cardiac | |||||||||
| Peripheralvascular | Peripheral vascular | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW
- Small Organ includes Thyroid, Testes, Breast
** Other use includes Urology, Kidney, Gynecology -
Note 1: Biopsy Guidance
Note 2: Harmonic Imaging, This feature does not use contrast agent.
(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)
Sz. D
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health K/23249 510(k)________________________________________________________________________________________________________________________________________________________________________
6-7
{12}------------------------------------------------
U50 with C6152UB Transducer
· Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | Note 1,2 | ||
| Small Organ (Specify) * | ||||||||
| FetalImaging& Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Adult Cardiac | ||||||||
| Pediatric Cardiac | N | N | N | N | N | Note 1,2 | ||
| Cardiac | Intravascular(Cardiac) | |||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | |||||||
| vascular | Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDV/DPDI, B+Color+PW, B+PDV/DPDI +PW
- Small Organ includes Thyroid, Testes, Breast
** Other use includes Urology, Kidney, Gynecology
Note 1: Biopsy Guidance
Note 2: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostic and Radiological Health
510(k) K123249
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U50 with C422UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined(Specify) | Other(Specify) | |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging& Other | Fetal / Obstetrics | ||||||||
| Abdominal | N | N | N | N | N | Note 1,2 | |||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro logical) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) * | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) ** | |||||||||
| Cardiac | Adult Cardiac | N | N | N | N | N | Note 1,2 | ||
| Pediatric Cardiac | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra- cardiac | |||||||||
| Peripheralvascular | Peripheral vascular | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW
- Small Organ includes Thyroid, Testes, Breast
** Other use includes Urology, Kidney, Gynecology
Note 1: Biopsy Guidance
Note 2: Harmonic Imaging, This feature does not use contrast agent.
(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)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health K123249 510(k)
6-9
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U50 with L552UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined (Specify) | Other (Specify) | |
| Ophthalmic | Ophthalmic | Ophthalmic | |||||||
| FetalImaging& Other | Fetal / Obstetrics | ||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro logical) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | Note 1,2 | |||
| Small Organ (Specify) * | N | N | N | N | N | Note 1,2 | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | Note 1,2 | |||
| Musculo-skeletal (Superficial) | N | N | N | N | N | Note 1,2 | |||
| Intravascular | |||||||||
| Other (Specify) ** | |||||||||
| Cardiac | Adult Cardiac | ||||||||
| Pediatric Cardiac | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra- cardiac | |||||||||
| Peripheralvascular | Peripheral vascular | N | N | N | N | N | Note 1,2 | ||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDVDPDI, B+Color+PW, B+PDVDPDI +PW
- Small Organ includes Thyroid, Testes, Breast
** Other use includes Urology, Kidney, Gynecology
Note 1: Biopsy Guidance
Note 2: Harmonic Imaging, This feature does not use contrast agent.
(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)
(Division Sign Off)
Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health K123249 510(k)
§ 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.