(23 days)
The CX50 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical --mode), Pulse Wave Doppler, continuous Wave Doppler, color Doppler, tissue Doppler Imaging and Harmonics (Tissue and contrast) modes. The device is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic, Fetal, Abdominal, Pediatric, Small Organ, Adult Cephalic, Neonatal Cephalic, Trans-vaginal, Musculo-skeletal, Gynecological, Cardiac Adult, Cardiac pediatric, Trans-Esoph. (Cardiac), Peripheral Vessel, Other (Carotid)
The CX50 Diagnostic Ultrasound System is a compact, AC or battery powered, 128 channel, cardiac ultrasound imaging. It uses custom digital electronic and fabrication technologies to provide diagnostic ultrasound information and is housed in a portable, laptop-style chassis. The only changes made in this CX50 510(k) are the additional indications of Cardiac Pediatric and Neonatal Cephalic. There are no new or unique features/technical characteristics introduced with the addition of the new indications.
The Philips CX50 Diagnostic Ultrasound System received clearance for additional indications for Cardiac Pediatric and Neonatal Cephalic applications. This was a 510(k) Premarket Notification based on substantial equivalence to predicate devices (Philips HD11 Diagnostic Ultrasound System, K043535 and earlier CX50 submissions K091804 and K081802). The submission states that no new features or technical characteristics were introduced.
Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define quantitative "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, resolution) for the new indications. Instead, the "acceptance criteria" for this 510(k) largely revolve around demonstrating substantial equivalence to previously cleared devices for these specific indications and confirming that no new safety or effectiveness concerns arise.
The "device performance" reported is that the CX50 system, with the additional indications, is substantially equivalent in safety and effectiveness to its predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| No new hazards identified with the addition of Cardiac Pediatric and Neonatal Cephalic indications. | "No new hazards were identified with the addition of cardiac pediatric and neonatal cephalic indications." |
| No new testing required to determine safety and efficacy with the new indications. | "No new testing was required to determine safety and efficacy of the CX50 with the new indications." |
| Clinical safety and effectiveness of the system and transducers for the new indications are well accepted and identified in previous submissions. | "The clinical safety and effectiveness of the system and transducers were identified in previous CX50 submissions (K091804 and K081802). The clinical safety and effectiveness of the Neonatal Cephalic and Cardiac Pediatric indications are well accepted for use with ultrasound systems including the predicate device, Philips HD11 (K043535)." The CX50 with additional indications is "substantially equivalent in safety and effectiveness to the predicate identified above." |
| Same gray-scale and Doppler capabilities as predicate devices. | "The predicate devices and CX50 with additional indications have the same gray-scale and Doppler capabilities." |
| Essentially same technologies for imaging, Doppler functions, and signal processing as predicate devices. | "The predicate devices and CX50 with additional indications use essentially the same technologies for imaging, Doppler functions and signal processing." |
| Acoustic output levels below Track 3 FDA limits, equivalent to predicate devices. | "The predicate devices and CX50 with additional indications have acoustic output levels below the Track 3 FDA limits." |
| Manufactured under equivalent quality systems as predicate devices. | "The predicate devices and CX50 with additional indications are manufactured under equivalent quality systems." |
| Manufactured of materials with equivalent biosafety and found to be safe, equivalent to predicate devices. | "The predicate devices and CX50 with additional indications are manufactured of materials with equivalent biosafety. The materials have been evaluated and found to be safe for this application." |
| Designed and manufactured to the same electrical and physical safety standards as predicate devices. | "The predicate devices and CX50 with additional indications are designed and manufactured to the same electrical and physical safety standards." |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or clinical study data is provided for the new indications with the CX50. The submission explicitly states: "No new testing was required to determine safety and efficacy of the CX50 with the new indications."
Safety and effectiveness were demonstrated through substantial equivalence to existing predicate devices already cleared for these applications, and through previous submissions for the CX50 system itself. Therefore, there is no explicit "sample size used for the test set" or direct "data provenance" for this 510(k) submission regarding the new indications. The reliance is on prior clearances.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no new clinical testing was performed for this specific 510(k) for the new indications, there is no mention of "experts used to establish ground truth for the test set." The substantial equivalence argument relies on the established safety and efficacy of the predicate devices.
4. Adjudication Method for the Test Set
As no specific test set or clinical study was conducted for the new indications in this submission, no adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs Without AI Assistance
No MRMC comparative effectiveness study was conducted or referenced in this submission. The device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of image interpretation software.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This submission is for a diagnostic ultrasound system, which inherently requires a human operator and interpreter. It is not an "algorithm only" device, and therefore, no standalone algorithmic performance study was conducted.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Given that no new clinical study was performed for the new indications, no specific "type of ground truth" was established or used for this submission pertaining to the new indications. The ground truth for the clinical safety and effectiveness of the predicate ultrasound systems would have been established through methodologies typical for medical device approvals at their time, likely involving assessments by qualified medical professionals (e.g., radiologists, cardiologists) correlating ultrasound findings with patient presentation, other diagnostic tests, or clinical outcomes.
8. The Sample Size for the Training Set
No training set is mentioned as part of this 510(k) submission, as it relates to the addition of new indications to an existing ultrasound system. The device itself is not a machine learning or AI-driven algorithm that would typically require a training set for its core functionality.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned in this submission, there is no information on how its ground truth would have been established.
{0}------------------------------------------------
510(k) Premarket Notification CX50 Diagnostic Ultrasound System with Additional Indications
JUN 2 4 2011
This summary of safety and effectiveness is provided as part of the Premarket Notification in compliance with 21CFR. Part 807, Subpart E, Section 807.92
- Submitter's name, address, telephone number, contact person
Penny Greco Philips Ultrasound, Inc. Regulatory Affairs Specialist 3000 Minuteman Road Andover, MA 01810-6302 Tel: (978) 659-4615 Fax (978) 975-7324
Date prepared: May 23, 2011
- 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 and transducers
Proprietary Name: CX50 Diagnostic Ultrasound System
Classification Name: Class II
| 21 CFRSection | Classification Name | Product Code |
|---|---|---|
| 892.1550 | System, Imaging, Pulsed Doppler,Ultrasonic | 90 IYN |
| 892.1560 | System, Imaging, Pulsed Echo, Ultrasonic | 90 IYO |
| 892.1570 | Transducer, Ultrasonic, diagnostic | 90 ITX |
- Substantially Equivalent Devices
| CX50 Diagnostic Ultrasound System | K091804 / K081802 |
|---|---|
| HD11 Diagnostic Ultrasound System | K043535 |
3) Device Description
The CX50 Diagnostic Ultrasound System is a compact, AC or battery powered, 128 channel, cardiac ultrasound imaging. It uses custom digital electronic and fabrication technologies to provide diagnostic ultrasound information and is housed in a portable, laptop-style chassis. The only changes made in this CX50 510(k) are the additional indications of Cardiac Pediatric and Neonatal Cephalic. There are no new or unique features/technical characteristics introduced with the addition of the new indications.
Page 6 of 33
{1}------------------------------------------------
Cardiac Pediatric and Neonatal Cephalic indications have been previously cleared for other Philips Ultrasound systems, including the predicate device, HD11 Ultrasound system (K043535). This modification to the CX50 involves only the two new indications, as reflected in labeling.
4) Intended Use
The CX50 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical --mode), Pulse Wave Doppler, continuous Wave Doppler, color Doppler, tissue Doppler Imaging and Harmonics (Tissue and contrast) modes. The device is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic, Fetal, Abdominal, Pediatric, Small Organ, Adult Cephalic, Neonatal Cephalic, Trans-vaginal, Musculo-skeletal, Gynecological, Cardiac Adult, Cardiac pediatric, Trans-Esoph. (Cardiac), Peripheral Vessel, Other (Carotid)
5) Technological comparison to predicate devices
Philips CX50 and HD11 Diagnostic Ultrasound are Track 3 systems that employ the same fundamental scientific technology.
6) Determination of Substantial Equivalence
Non-clinical performance data
No new hazards were identified with the addition of cardiac pediatric and neonatal cephalic indications. No new testing was required to determine safety and efficacy of the CX50 with the new indications.
Summary of Clinical Tests
The CX50 required no modifications to support the neonatal cephalic and cardiac pediatric indications. The clinical safety and effectiveness of the system and transducers were identified in previous CX50 submissions (K091804 and K081802). The clinical safety and effectiveness of the Neonatal Cephalic and Cardiac Pediatric indications are well accepted for use with ultrasound systems including the predicate device, Philips HD11 (K043535).
{2}------------------------------------------------
7) Conclusions
CX50 with additional indications is substantially equivalent in safety and effectiveness to the predicate identified above:
- . The predicate devices and CX50 with additional indications are indicated for the diagnostic ultrasonic imaging and fluid flow analysis.
- The predicate devices and CX50 with additional indications have the same gray-scale and . Doppler capabilities.
- The predicate devices and CX50 with additional indications use essentially the same . technologies for imaging, Doppler functions and signal processing.
- The predicate devices and CX50 with additional indications have acoustic output levels . below the Track 3 FDA limits.
- . The predicate devices and CX50 with additional indications are manufactured under equivalent quality systems.
- The predicate devices and CX50 with additional indications are manufactured of . materials with equivalent bio safety. The materials have been evaluated and found to be safe for this application.
- . The predicate devices and CX50 with additional indications are designed and manufactured to the same electrical and physical safety standards.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Philips Ultrasound, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO NY 55313
JUN 2 4 2011
Re: K111513
Trade/Device Name: Philips CX50 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 31, 2011 Received: June 1, 2011
Dear Mr. Job:
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 Philips CX50 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number ટર-I L12-3
C9-3v C2-1 D5-cwc D2cwc X7-2t
{4}------------------------------------------------
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 895. 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Joshua Nipper at (301) 796-6524.
Sincerely Yours,
Mary S Patil
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): KIJ1513
Device Name: Philips CX50 Diagnostic Ultrasound System
Philips CX50 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
- Ophthalmic Fetal Abdominal Pediatric Small Organ Adult Cephalic Neonatal Cephalic Trans-vaginal Musculo-skeletal Gynecological Cardiac Adult Cardiac Pediatric Trans-Esoph. (Cardiac) Peripheral Vessel Other (Carotid)
The clinical environments where the CX50 Diagnostic Ultrasound System can be used include point-of-care areas in offices, clinical and hospital settings for diagnosis of patients.
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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K111513
Page 1 of 9
ﺳﺮﺓ ﺍﻟﺘﻮﺩﻳ
24 11:52 :
{6}------------------------------------------------
મારા ક
CX50 Diagnostic Ultrasound System Device name:
510(k) Number: _
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track IOnly) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Specify)See below | Other*(Specify) |
| Ophthalmic | Ophthalmic | P | P | P | P | P | P (1,4,6,7) | |
| Fetal/Obstetric | P | P | P | P | P | P | P (1,3-8) | |
| Abdominal | P | P | P | P | P | P | P (1,3-9) | |
| Intra-operative(vascular/epicardial) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatric | P | P | P | P | P | P (1,3-8) | |
| Small Organ (thyroid,scrotum, prostate, breast) | P | P | P | P | P | P (1,3-8) | ||
| Neonatal Cephalic | N | N | N | N | N | N | N(1-8) | |
| Adult Cephalic | P | P | P | P | P | P | P (1,3-7) | |
| Trans-rectal | ||||||||
| Trans-vaginal | P | P | P | P | P | P (1,3-8) | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Musculo-skel(conventional) | P | P | P | P | P | P (1,3-8) | ||
| Musculo-skel (superficial) | P | P | P | P | P | P (1,3-8) | ||
| Other (Gynecological) | P | P | P | P | P | P (1,3-9) | ||
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P(1-4) |
| Cardiac Pediatric | N | N | N | N | N | N | N (1-7) | |
| Trans-esoph. (Cardiac) | P | P | P | P | P | P | P(1-4) | |
| Other (Fetal) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P | P (1,3-8) |
| Other (Carotid) | P | P | P | P | P | P (1,3-8) | ||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||
| *Other modes:1. Harmonics (Tissue or Contrast) | 5. Angio Imaging6. 3D (Freedhand) Imaging |
| *Other modes: | 5. Angio Imaging |
|---|---|
| 1. Harmonics (Tissue or Contrast) | 6. 3D (Freedhand) Imaging |
| 2. Tissue Doppler Imaging | 7. SonoCT |
| 3. iSCAN | 8. Biopsy guidance |
| 4. X-Res | 9. Infertility monitoring of follicle development |
| Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD | |
| Previous submission: K091804 for 2.0 release of CS50 |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics
Prescription Use (Per 21 CFR 801.109)
Page 2 of 9
{7}------------------------------------------------
1111513 510(k) Number: _
S5-1 transducer for use with CX50 Diagnostic Ultrasound System Device name:
Intended Use: Diagnostic ultrasound imaging or tluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track IOnly) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Specify)See below | Other*(Specify) |
| Ophthalmic | Ophthalmic | P | P | P | P | P | P(1.4.6,7) | |
| Fetal/Obstetric | ||||||||
| Abdominal | P | P | P | P | P | P (1.3-8) | ||
| Intra-operative(vascular/epicardial) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatric | |||||||
| Small Organ (thyroid, scrotum,prostate, breast) | ||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N (1-8) | |
| Adult Cephalic | P | P | P | P | P | P | P (1,3-7) | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac Adult | P | P | P | P | P | P | P | |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | N | N (1-7) |
| Trans-esoph. (Cardiac) | ||||||||
| Other (Fetal) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) | ||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||
| *Other modes: | 5. Angio Imaging | |||||||
| 1. Harmonics (Tissue & Contrast) | 6. 3D (Freedhand) Imaging | |||||||
| 2. Tissue Doppler Imaging | 7. SonoCT | |||||||
| 3. iSCAN | 8. Biopsy guidance | |||||||
| 4. X-Res | 9. Infertility monitoring of follicle development | |||||||
| Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD |
Previous submission: K091804 – use of S5-1 transducer with the 2.0 release of CX50
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics
Prescription Use (Per 21 CFR 801.109)
| (Division Sign-Off) |
|---|
| --------------------- |
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510K | K111513 |
|---|---|
| ------ | --------- |
Page 3 of 9
{8}------------------------------------------------
1111513 510(k) Number:
L12-3 transducer for use with CX50 Diagnostic Ultrasound System Device name:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(Track IOnly) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Specify)See below | Other*(Specify) | ||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal/Obstetric | ||||||||||
| Abdominal | P | P | P | P | P | P (1,3-8) | ||||
| Intra-operative(vascular/epicardial) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| FetalImaging& Other | Pediatric | P | P | P | P | P | P (1,3-8) | |||
| Small Organ (thyroid, scrotum,prostate, breast) | P | P | P | P | P | P (1,3-8) | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Intra-luminal | ||||||||||
| Musculo-skel (conventional) | P | P | P | P | P | P (1,3-8) | ||||
| Musculo-skel (superficial) | P | P | P | P | P | P (1,3-8) | ||||
| Other (Gynecological) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Other (Fetal) | ||||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P (1,3-8) | |||
| Other (Carotid) | P | P | P | P | P | P (1,3-8) | ||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||||
| *Other modes: | 5. Angio Imaging | |||||||||
| 1. Harmonics (Tissue & Contrast) | 6. 3D (Freedhand) Imaging | |||||||||
| 2. Tissue Doppler Imaging | 7. SonoCT | |||||||||
| 3. iSCAN | 8. Biopsy guidance |
Previous submission: K091804- use of L12-3 transducer with the 2.0 release of CX50
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics
Combined modes: B+PWD, B+Color, B+M+Color, B+Color+PWD, B+CWD, B+CWD, B+Color+CWD
Prescription Use (Per 21 CFR 801.109)
- X-Res ·
| (Division Sign-Off) | |
|---|---|
| Division of Radiological Devices | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | |
| 510K | K111513 |
- Infertility monitoring of follicle development
Page 4 of 9
{9}------------------------------------------------
K111513 510(k) Number: _
C9-3v transducer for use with CX50 Diagnostic Ultrasound System Device name:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| General(Track IOnly) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Specify)See below | Other*(Specify) | |||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal/Obstetric | P | P | P | P | P | P (1,3-8) | |||||
| Abdominal | P | P | P | P | P | P (1,3-9) | |||||
| Intra-operative(vascular/epicardial) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| FetalImaging& Other | Pediatric | ||||||||||
| Small Organ (thyroid, scrotum,prostate, breast) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | P | P | P | P | P | P (1,3-9) | |||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Intra-luminal | |||||||||||
| Musculo-skel (conventional) | |||||||||||
| Musculo-skel (superficial) | |||||||||||
| Other (Gynecological) | P | P | P | P | P | P (1,3-9) | |||||
| Cardiac Adult | |||||||||||
| Cardiac | Cardiac Pediatric | ||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Other (Fetal) | |||||||||||
| PeripheralVessel | Peripheral vessel | ||||||||||
| Other (Specify) |
Previous submission: K091804 - use of C9-3v transducer with the 2.0 release of CX50
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics
Prescription Use (Per 21 CFR 801.109)
| (Division Sign-Off) |
|---|
| --------------------- |
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510K | K111513 |
|---|---|
| ------ | --------- |
{10}------------------------------------------------
111513 510(k) Number:
Device name: C5-1 transducer for use with CX50 Diagnostic Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track IOnly) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Specify)See below | Other*(Specify) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal/Obstetric | P | P | P | P | P | P (1,3-8) | |||
| Abdominal | P | P | P | P | P | P (1,3-9) | |||
| Intra-operative(vascular/epicardial) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| FetalImaging& Other | Pediatric | P | P | P | P | P | P (1,3-9) | ||
| Small Organ (thyroid, scrotum,prostate, breast) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Intra-luminal | |||||||||
| Musculo-skel (conventional) | |||||||||
| Musculo-skel (superficial) | P | P | P | P | P | P (1,3-8) | |||
| Other (Gynecological) | P | P | P | P | P | P (1,3-9) | |||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| PeripheralVessel | Other (Fetal) | ||||||||
| Peripheral vessel | P | P | P | P | P | P (1,3-8) | |||
| Other (Specify) | |||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | |||||||||
| *Other modes: | 5. Angio Imaging | ||||||||
| 1. Harmonics (Tissue & Contrast) | 6. 3D (Freedhand) Imaging | ||||||||
| 2. Tissue Doppler Imaging | 7. SonoCT | ||||||||
| 3. ISCAN | 8. Biopsy guidance | ||||||||
| 9. Infertility monitoring of follicle development | |||||||||
| Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD | |||||||||
| Previous submission: K091804- use of C5-1 transducer with the 2.0 release of CX50 |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics
Prescription Use (Per 21 CFR 801.109)
| (Division Sign-Off) | |
|---|---|
| Division of Radiological Devices | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | |
| 510K | K111513 |
Page 6 of 9
{11}------------------------------------------------
1111513 510(k) Number: J
D5cwc transducer for use with CX50 Diagnostic Ultrasound System Device name:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(Track IOnly) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Specify)See below | Other*(Specify) | ||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal/Obstetric | ||||||||||
| Abdominal | ||||||||||
| Intra-operative | ||||||||||
| (vascular/epicardial) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| FetalImaging& Other | Laparoscopic | |||||||||
| Pediatric | ||||||||||
| Small Organ (thyroid, scrotum, | ||||||||||
| prostate, breast) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Intra-luminal | ||||||||||
| Musculo-skel (conventional) | ||||||||||
| Musculo-skel (superficial) | ||||||||||
| Other (Gynecological) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | N | N (1-7) | |||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Other (Fetal) | ||||||||||
| Peripheral | Peripheral vessel | P | ||||||||
| Vessel | Other (Carotid) | P | ||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||||
| *Other modes: | ||||||||||
| 1. Harmonics (Tissue & Contrast) | ||||||||||
| 2. Tissue Doppler Imaging | ||||||||||
| 3. iSCAN | ||||||||||
| 4. X-Res |
Combined modes: B+PWD, B+Color, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD Previous submission: K091804- use of D5cwc transducer with the 2.0 release of CX50
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510K | K111513 |
|---|---|
| ------ | --------- |
{12}------------------------------------------------
| 510(k) Number: | K111573 |
|---|---|
| Device name: | D2cwc transducer for use with CX50 Diagnostic Ultrasound System |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I Only) | Specific(Tracks I & III) | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging & Other | Fetal/Obstetric | |||||||
| Abdominal | ||||||||
| Intra-operative (vascular/epicardial) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (thyroid, scrotum, prostate, breast) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Musculo-skel (conventional) | ||||||||
| Musculo-skel (superficial) | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac | Cardiac Adult | P | ||||||
| Cardiac Pediatric | N | N (1-7) | ||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Fetal) | ||||||||
| Peripheral Vessel | Peripheral vessel | |||||||
| Other (Specify) |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E |
|---|
| * Other modes: |
| Combined modes: |
Previous submission: K081802- use of D2cwc transducer with the first release of CX50
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics
Prescription Use (Per 21 CFR 801.109)
| (Division Sign-Off) |
|---|
| Division of Radiological Devices |
| Office of In Vitro Diagnostic Device Evaluation and Safety |
| 510K | K111513 |
|---|---|
| ------ | --------- |
Page 8 of 9
{13}------------------------------------------------
KII 213 510(k) Number:
Device name: X7-2t transducer for use with CX50 Diagnostic Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Property 1.7 Mode of Operation
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track IOnly) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) | |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging& Other | Fetal/ObstetricAbdominalIntra-operative(vascular/epicardial)Intra-operative (Neuro)LaparoscopicPediatricSmall Organ (thyroid, scrotum,prostate, breast)Neonatal CephalicAdult CephalicTrans-rectalTrans-vaginalTrans-urethralTrans-esoph. (non-Card.)Intra-luminalMusculo-skel (conventional)Musculo-skel (superficial)Other (Gynecological) | ||||||||
| Cardiac | Cardiac AdultCardiac PediatricTrans-esoph. (Cardiac)Other (Fetal) | P | P | P | P | P | P | P | |
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (Specify) | |||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E |
- Other modes: Harmonics (Tissue & Contrast), Tissue Doppler Imaging
| Combined modes: | B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD |
|---|---|
| Previous submission: | K081802- use of X7-2t transducer with the first release of CX50 |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510K | K111513 |
|---|---|
| ------ | --------- |
Page 9 of 9
§ 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.