(29 days)
The CX50 2.0 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 clinical applications: Cardiac (adult), Ophthalmic, Fetal, Abdominal, Pediatric, Musculoskeletal, Peripheral Vessel, Small Organ, Trans-vaginal, Adult Cephalic, and Gynecological.
CX50 2.0 is a modification of the CX50 (1.0) compact diagnostic ultrasound system cleared for Philips Ultrasound in K081802. The 2.0 modification adds 4 additional transducers for use with the CX50 system; these transducers and software changes in release 2.0 enable expanded intended uses for the CX50 system. These expanded intended uses are all within the cleared intended uses for the predicate device, Philips iU22 diagnostic ultrasound system cleared in K030455), to which CX50 2.0 is substantially equivalent.
Here’s an analysis of the provided text regarding the Philips CX50 2.0 Diagnostic Ultrasound System, focusing on acceptance criteria and supporting studies.
Important Note: This document describes a 510(k) premarket notification. For ultrasound systems, particularly for updates adding new transducers or expanding indications, the primary "study" proving acceptance criteria is often demonstrating Substantial Equivalence (SE) to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate, without raising new questions of safety or effectiveness. Direct performance metrics like sensitivity, specificity, accuracy, or reader study results, which are common for AI-based or novel diagnostic devices, are usually not extensively detailed in such 510(k) summaries unless a significant new technology or clinical claim (beyond equivalence) is being made.
Therefore, the "acceptance criteria" here largely refers to the criteria for demonstrating substantial equivalence, and the "study" is the comparison made against the predicate devices.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (Claimed Equivalence) |
|---|---|
| Intended Use: Device is indicated for diagnostic ultrasound imaging and fluid flow analysis. Expanded uses remain within the scope of the predicate device. | CX50 2.0: Intended for diagnostic ultrasound imaging and fluid flow analysis in Cardiac (adult), Ophthalmic, Fetal, Abdominal, Pediatric, Musculoskeletal, Peripheral Vessel, Small Organ, Trans-vaginal, Adult Cephalic, and Gynecological applications. Predicate (Philips iU22): Cleared for these intended uses. CX50 2.0's expanded uses (via new transducers/software) are covered by the predicate. |
| Technological Characteristics: - Same gray-scale and Doppler capabilities. - Essentially same technologies for imaging, Doppler, and signal processing. | CX50 2.0 & Predicate: Both have the same gray-scale and Doppler capabilities. Both use essentially the same technologies for imaging, Doppler functions, and signal processing. |
| Safety: - Acoustic output levels below FDA limits. - Manufactured under equivalent quality systems. - Materials with equivalent biosafety and found safe. - Designed and manufactured to same electrical and physical safety standards. | CX50 2.0 & Predicate: - Both have acoustic output levels below Track 3 FDA limits. - Both are manufactured under equivalent quality systems. - Both are manufactured of materials with equivalent biosafety, found safe. - Both are designed and manufactured to the same electrical and physical safety standards. |
| Effectiveness: The device performs as effectively as the predicate for its stated indications. | CX50 2.0 & Predicate: Demonstrated substantial equivalence to the Philips iU22 diagnostic ultrasound system (K030455) and the CX50 (1.0 release) (K081802). The new transducers integrate capabilities already cleared on other Philips systems, or are minor modifications of previously cleared transducers. The "Integrated Ultrasound" capability facilitates workflow, which is not a direct diagnostic performance claim but an operational improvement. The FDA's clearance (K091804) indicates acceptance of this demonstrated equivalence. |
Study Details Proving Acceptance Criteria
Given this is a 510(k) for a modification to an existing ultrasound system, the "study" is primarily an equivalence demonstration rather than a traditional performance study with a test set, ground truth, etc., as one would expect for a novel diagnostic algorithm.
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not describe a specific "test set" of patient data for evaluating diagnostic performance in the way a clinical trial might.
- The "test" for this 510(k) is the comparison of the CX50 2.0's design, technology, and indications for use against the cleared predicate devices (Philips iU22 and CX50 1.0). This is inherent in the 510(k) process for demonstrating substantial equivalence.
- Data Provenance: Not applicable in the sense of patient data. The provenance for the comparison comes from the design specifications, technical documentation, and safety testing (e.g., acoustic output, biosafety, electrical/physical safety) of both the new device and the predicate(s). This is retrospective, drawing on existing clearances and design files.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. Ground truth in this context refers to the established safety and effectiveness of the predicate devices, as determined by prior FDA clearances and accepted industry standards. There isn't a "ground truth" established by a panel of experts for a novel diagnostic performance claim within this 510(k) summary. The "ground truth" is the regulatory standard for safety and effectiveness that the predicate device already met.
4. Adjudication Method for the Test Set:
- Not applicable. As there is no specific "test set" of patient cases requiring ground truth, there is no adjudication method described. The FDA reviewer performs the "adjudication" by reviewing the submission and determining if substantial equivalence is met.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done (or at least, not mentioned in this summary). This type of study is usually conducted when a device introduces a new diagnostic capability or significantly alters the interpretation of images, requiring a comparison of human reader performance with and without the device. The CX50 2.0 is an expansion of an existing ultrasound platform, demonstrating equivalence to an already cleared device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No, a standalone performance study was not done. This device is a diagnostic ultrasound system, which inherently requires a human operator and interpreter. It does not include an "algorithm only" component that would be evaluated in a standalone manner.
7. Type of Ground Truth Used:
- Regulatory Standard of Substantial Equivalence: The "ground truth" is effectively the established safety and effectiveness profile of the predicate devices (Philips iU22 diagnostic ultrasound system K030455 and the CX50 1.0 system K081802). The submission asserts that all new features and indications of CX50 2.0 fall within, or are substantially equivalent to, these previously cleared devices. This includes adherence to FDA guidance, acoustic output limits, biosafety, and electrical/physical safety standards.
8. Sample Size for the Training Set:
- Not applicable. The CX50 2.0 is an ultrasound imaging system, not an AI/ML algorithm that develops its diagnostic capabilities from a "training set" of data. Its performance is based on established ultrasound physics, transducer design, and signal processing.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no "training set" for this type of device, no ground truth was established for it.
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JUL 1 7 2009
Summary of Safety and Effectiveness: Philips CX50 2.0 K091804
The submitter of this premarket notification is:
Rob Butler Manager, Regulatory Affairs Philips Ultrasound, Inc. 3000 Minuteman Road Andover, MA 01810-6302 Tel: (978) 659-2785 Fax: (978) 975-7324
This summary was prepared on June 17, 2009.
The proprietary name of the device is the CX50 Diagnostic Ultrasound System. In combination with its compatible transducers, the system is commonly known as a diagnostic ultrasound system and transducers.
These devices are classified as follows:
| 90IYN | Ultrasonic Pulsed Doppler Imaging System |
|---|---|
| 90IYO | Ultrasonic Pulsed Echo Imaging System |
90ITX Diagnostic Ultrasound Transducer
As stated in 21 CFR, parts 892.1550, 892.1560 and 892.1570, each of these generic types of devices have been classified as Class II.
CX50 2.0 is a modification of the CX50 (1.0) compact diagnostic ultrasound system cleared for Philips Ultrasound in K081802. The 2.0 modification adds 4 additional transducers for use with the CX50 system; these transducers and software changes in release 2.0 enable expanded intended uses for the CX50 system. These expanded intended uses are all within the cleared intended uses for the predicate device, Philips iU22 diagnostic ultrasound system cleared in K030455), to which CX50 2.0 is substantially equivalent.
CX50 2.0 is intended for diagnostic ultrasound imaging and fluid flow analysis.
CX50 2.0 is substantially equivalent in safety and effectiveness to the predicate identified above:
- Both the predicate device and CX50 2.0 are indicated for the diagnostic ultrasonic . imaging and fluid flow analysis.
- . Both the predicate device and CX50 2.0 have the same gray-scale and Doppler capabilities.
- Both the predicate device and CX50 2.0 use essentially the same technologies for . imaging, Doppler functions and signal processing.
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- . Both the predicate device and CX50 2.0 have acoustic output levels below the Track 3 FDA limits.
- Both the predicate device and CX50 2.0 are manufactured under equivalent quality ● systems.
- Both the predicate device and CX50 2.0 are manufactured of materials with . equivalent biosafety. The materials have been evaluated and found to be safe for this application.
- . Both the predicate device and CX50 2.0 are designed and manufactured to the same electrical and physical safety standards.
Introduction
This 510(k) premarket notification submission has been prepared in adherence with the FDA guidance; Information for Manufactures Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, issued on September 9, 2008.
Basic Information
Manufacturer's Name
Philips Ultrasound 22100 Bothell Everett Highway Bothell, WA 98021-8431
Corresponding Official for this submission Rob Butler 3000 Minuteman Rd Andover, MA 01810 Phone (978) 659-2785 Fax (978) 975-7234
Initial distributor:
Philips Ultrasound 22100 Bothell Everett Highway Bothell, WA 98021-8431
Device Name
CX50 Diagnostic Ultrasound System. This submission covers the 2.0 release of CX50.
Common Name:
Diagnostic Ultrasound System and Transducers
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Classification
| Regulatory Class: | II |
|---|---|
| Review Category: | Tier II |
| Review Panel: | Radiology |
| Device Name | FR Number | 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 |
Establishment Registration Number
Philips Ultrasound, Inc. 1217116
514 Performance Standards
There are no Sec. 514 performance standards for this device.
Prescription Status
This is a prescription device. The prescription device statement appears in the labeling.
Manufacturing Location
Philips Ultrasound 22100 Bothell Everett Highway Bothell, WA 98021-8431
Sterilization Site(s)
Not applicable. No components supplied sterile.
Reason for Submission
The contents of this submission describe the 2.0 release of CX50 - modifications to the CX50 (1.0 release) system previously cleared in K081802. The changes include:
- Adding to CX50 indications for use and features that are already cleared for use on the predicate device (Philips iU22 ultrasound system -K030455)
- Adding 4 transducers to CX50; 2 have been previously cleared on other Philips ultrasound systems; 2 are minor modifications of previously cleared transducers
- Adding Antegrated Ultrasound" capability, which facilitates workflow between the CX50 and the Philips Allura Xper X-ray system (K041949).
Track
This is a Track 3 system.
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Indications for Use
The CX50 2.0 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 clinical applications: Cardiac (adult), Ophthalmic, Fetal, Abdominal, Pediatric, Musculoskeletal, Peripheral Vessel, Small Organ, Trans-vaginal, Adult Cephalic, and Gynecological.
ge 4 of 10
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.
These use models are within the scope of and substantially equivalent to current indications for use for Diagnostic Ultrasound System.
The 510(k) Indications for Use forms on the following 6 pages show previously cleared indications for use for the CX50 (1.0 release) system and indications for use added with this 2.0 release of CX50. The CX50 2.0 release made no changes to the indications for use for the X7-2t and D2cwc transducers as cleared on K081802, so no Indications for Use form is provided for those two transducers. The CX50 2.0 release does add indications for use for the S5-1 transducer from what was cleared on K081802, so an Indication for Use form for S5-T is included in this submission, showing both previously cleared and new (with CX50 2.0) indications for use.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
JUL 1 7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Ultrasound, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K091804
Trade/Device Name: CX50 2.0 Diagnostic Ultrasound System and Transducers Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 3, 2009 Received: July 6, 2009
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 CX50 2.0 Diagnostic Ultrasound System and Transducers, as described in your premarket notification:
SS-1 L12-3 C9-3v CS-1 DScwc
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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (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.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact William C. Jung at (240) 276-3666.
Sincerely yours,
Hubert Reiner
ne M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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Indications for Use
510(k) Number (if known): K091804
Device Name: __ CX50 2.0 Diagnostic Ultrasound System and Transducers
Indications for Use:
Cardiac (Adult, Trans-esophageal) (previously cleared in K081802)
Applications added in CX50 2.0: Ophthalmic Fetal Abdominal Pediatric Musculoskeletal Peripheral Vessel Small Organ Trans-vaginal Adult Cephalic Gynecological
"Integrated Ultrasound" - capable of facilitating work flow between CX50 and Philips Allura Xper X-ray system (K041949)
Prescription Use × (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 Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal and Radiological Devices | |
| 510(k) Number | K091804 |
Page 1 of 7
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69/804 510(k) Number:
Device name: CX50 2.0 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 | N | N | N | N | N | N (1,4,6,7) | |
| Fetal/Obstetric | N | N | N | N | N | N | N (1,3-8) | |
| Abdominal | N | N | N | N | N | N | N (1,3-9) | |
| Intra-operative(vascular/epicardial) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatric | N | N | N | N | N | N (1,3-8) | |
| Small Organ (thyroid,scrotum, prostate, breast) | N | N | N | N | N | N (1,3-8) | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | N | N | N | N | N | N | N (1,3-7) | |
| Trans-rectal | ||||||||
| Trans-vaginal | N | N | N | N | N | N (1,3-8) | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Musculo-skel(conventional) | N | N | N | N | N | N (1,3-8) | ||
| Musculo-skel (superficial) | N | N | N | N | N | N (1,3-8) | ||
| Other (Gynecological) | N | N | N | N | N | N (1,3-9) | ||
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P(1-4) |
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | P | P | P | P | P | P | P(1-4) | |
| Other (Fetal) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | N | N | N (1,3-8) |
| Other (Carotid) | N | N | N | N | N | N (1,3-8) | ||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||
| *Other modes: | 5. Angio 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: K081802 for first release of CX50
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiotogical Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
(Division Sign-ON) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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091804 510(k) Number:
S5-1 transducer for use with CX50 2.0 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 I Only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Specify)See below | Other*(Specify) | ||
| Ophthalmic | Ophthalmic | N | N | N | N | N | N(1,4,6,7) | |||
| Fetal/Obstetric | ||||||||||
| Abdominal | N | N | N | N | N | N (1,3-8) | ||||
| FetalImaging& Other | Intra-operative(vascular/epicardial) | |||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (thyroid,scrotum, prostate, breast) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | N | N | N | N | N | N | N (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 | |||||||||
| 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: | 1. Harmonics (Tissue & Contrast) | 5. Angio Imaging | ||||||||
| 2. Tissue Doppler Imaging | 6. 3D (Freedhand) Imaging | |||||||||
| 3. iSCAN | 7. SonoCT | |||||||||
| 4. X-Res | 8. Biopsy guidance9. Infertility monitoring of follicle development | |||||||||
| Combined modes: B+PWD. B+Color. B+M+Color. B+Color+PWD. B+CWD. B+Color+CWD |
Previous submission: K081802 - use of S5-1 transducer with 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 Device Evaluation
Prescription Use (Per 21 CFR 801,109)
(Division Sign-Off)
Division of Reproductive, Abdominal an Radiological Devices 510(k) Number
page 3 of 7
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| 510(k) Number: | K091804 | |||||||
|---|---|---|---|---|---|---|---|---|
| Device name: | L12-3 transducer for use with CX50 2.0 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 | PWD | CWD | ColorDoppler | Combined(Specify)See below | Other*(Specify) |
| (Track IOnly) | (Tracks I & III) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetric | ||||||||
| Abdominal | N | N | N | N | N | N (1,3-8) | ||
| Intra-operative(vascular/epicardial) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatric | N | N | N | N | N | N (1,3-8) | |
| Small Organ (thyroid,scrotum, prostate, breast) | N | N | N | N | N | N (1,3-8) | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Musculo-skel(conventional) | N | N | N | N | N | N (1,3-8) | ||
| Musculo-skel (superficial) | N | N | N | N | N | N (1,3-8) | ||
| Other (Gynecological) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Fetal) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | N | N (1,3-8) | |
| Other (Carotid) | N | N | N | N | N | N (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 4. X-Res 9. Infertility monitoring of follicle development Combined modes: B+PWD, B+Color, B+M+Color, B+Color+PWD, B+CWD, B+CWD, B+Color+CWD Previous submission:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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804 00 510(k) Number: Device name: C9-3v transducer for use with CX50 2.0 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 | N | N | N | N | N | N (1,3-8) | ||
| Abdominal | N | N | N | N | N | N (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 | N | N | N | N | N | N (1,3-9) | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Musculo-skel(conventional) | ||||||||
| Musculo-skel (superficial) | ||||||||
| Other (Gynecological) | N | N | N | N | N | N (1,3-9) | ||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| 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+Color, B+Color+PWD, B+CWD, B+CWD, B+Color+CWD Previous submission:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal a Radiological Devices 510(k) Number
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091804 510(k) Number:
C5-1 transducer for use with CX50 2.0 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 | N | N | N | N | N | N (1,3-8) | ||
| Abdominal | N | N | N | N | N | N (1,3-9) | ||
| Intra-operative(vascular/epicardial) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatric | N | N | N | N | N | N (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) | N | N | N | N | N | N (1,3-8) | ||
| Other (Gynecological) | N | N | N | N | N | N (1,3-9) | ||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Fetal) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | N | N (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 | |||||||
| 4. X-Res | 9. Infertility monitoring of follicle development |
Combined modes: B+PWD, B+Color, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD Previous submission:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) U Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
page 6 of 7
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804 91 510(k) Number:
D5cwc transducer for use with CX50 2.0 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) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | 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 | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Fetal) | ||||||||
| PeripheralVessel | Peripheral vessel | N | ||||||
| Other (Carotid) | N |
Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD Previous submission:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Congurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.