(14 days)
The Xario XG is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).
The Xario XG Ultrasound System is a mobile system is a Track 3 device that employs a wide array of probes including, flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
This document is a 510(k) summary for a Diagnostic Ultrasound System. The purpose of a 510(k) is to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission usually focuses on technical comparisons and performance metrics against a known, cleared device, rather than extensive clinical studies with specific acceptance criteria in the sense of a new medical claim or algorithmic performance.
Therefore, the "acceptance criteria" here are primarily demonstrating substantial equivalence to the predicate device (Toshiba SSA-790A, Aplio XG Version 2.00 Diagnostic Ultrasound; 510(k) K072000) in terms of technical specifications, intended use, and safety standards. The "study" proving this largely involves comparing the specifications of the new device to the predicate device and certifying compliance with relevant industry standards.
1. Table of Acceptance Criteria and Reported Device Performance
Instead of traditional clinical acceptance criteria (e.g., sensitivity, specificity), the "acceptance criteria" for a 510(k) for an ultrasound system primarily revolves around demonstrating compliance with recognized safety and performance standards, and substantial equivalence to a predicate device for its intended uses.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Predicate Device Equivalence | Substantial equivalence to Toshiba SSA-790A, Aplio XG Version 2.00 Diagnostic Ultrasound (K072000). | The FDA has determined the device is substantially equivalent to legally marketed predicate devices. (This is the conclusion of the 510(k) review). The transudcers listed are shown to either have "N" (New Indication) or "P" (Previously Cleared by FDA, referencing K072000). |
| Safety and Manufacturing Standards Compliance | Compliance with: - Quality System Regulation - IEC 60601-1 (applicable portions) - IEC 60601-1-2 (applicable portion) - IEC60601-2-37 (applicable portions) - AIUM-NEMA UD2 Output Measurement Standard - AIUM-NEMA UD3 Output Display Standard | "This device is designed and manufactured in conjunction with the Quality System Regulation, IEC 60601-1 (applicable portions), IEC 60601-1-2 (applicable portion), IEC60601-2-37 (applicable portions), and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard." (Implied compliance is necessary for clearance). |
| Intended Use Claim | Intended for: Fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial) studies. | The device's use for these applications is cleared, based on substantial equivalence claim and the specific transducer modalities ("N" for new, "P" for previously cleared, across various clinical applications). |
| Acoustic Output (Post-Clearance Requirement) | Submission of complete acoustic output measurements based on production line devices, as requested in Appendix G of the "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." (Post-clearance condition). | This is a post-clearance condition; actual measured values are not in this summary but are required to be submitted to the FDA. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a specific "test set" in the context of diagnostic performance evaluation using patient data. For ultrasound systems seeking 510(k) clearance, the "test" typically involves:
- Bench testing: Verifying system specifications, safety features, and performance parameters against established standards.
- Comparison to predicate: Demonstrating that the technical design and performance (e.g., frequency ranges, imaging modes, transducer types) are comparable to a previously cleared device.
- Clinical use claims: Justifying the listed clinical applications based on the device's capabilities and equivalence to the predicate, rather than through a new, independent clinical trial with a specific patient sample size.
Therefore, there is no stated sample size or data provenance (country of origin, retrospective/prospective) related to a clinical test set for evaluating diagnostic accuracy or efficacy.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
As there is no described clinical test set for diagnostic performance, there is no mention of experts used to establish ground truth or their qualifications. The "ground truth" for a 510(k) ultrasound system clearance primarily rests on the device meeting engineering specifications and safety standards, and being technically equivalent to its predicate.
4. Adjudication Method for the Test Set
Again, since there is no described clinical test set for diagnostic performance, there is no adjudication method discussed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
No MRMC comparative effectiveness study is mentioned. This device is a Diagnostic Ultrasound System, and the 510(k) summary focuses on its technical specifications and equivalence to a predicate, not on human-AI assistive performance or AI capabilities.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
No standalone algorithm performance study is mentioned. This is a medical imaging hardware system, not an AI-driven algorithm, so such a study would not be applicable to this document.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established technical and safety standards (e.g., IEC, AIUM-NEMA) and the specifications and cleared indications of the predicate device (Toshiba SSA-790A, Aplio XG Version 2.00, K072000). There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for a diagnostic performance study in this 510(k) summary.
8. The Sample Size for the Training Set
There is no mention of a training set in this document. This clearance is for an ultrasound hardware system, not an AI or machine learning algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, this question is not applicable to the provided document.
{0}------------------------------------------------
357 9 8 1034
510(k) Summary of Safety and Effectiveness: 21 CFR 807.92
| Submitter's Name: Toshiba America Medical Systems, Inc. | |
|---|---|
| Address: | PO Box 2068, 2441 Michelle Drive Tustin, CA 92781-2068 |
| Contact: | Paul Biggins, Director Regulatory Affairs |
| Telephone No .: | (714) 730-5000 |
| Device Proprietary Name: | SSA-680A, Xario XG Version 1.00 |
|---|---|
| Common Name: | Diagnostic Ultrasound System |
Classification:
| Regulatory Class: | II |
|---|---|
| Review Category: | Tier II |
- . Ultrasonic Pulsed Doppler Imaging System - Product Code: 90-IYN [Fed. Reg. No.: 892.1550]
- . Ultrasonic Pulsed Echo Imaging System - Product Code: 90-IYO [Fed. Reg. No.: 892.1560]
- Diagnostic Ultrasonic Transducer Product Code: 90-ITX . [Fed. Reg. No .: 892.1570]
Identification of Predicate Devices:
Toshiba America Medical Systems believes that this device is substantially equivalent to:
Toshiba SSA-790A, Aplio XG Version 2.00 Diagnostic Ultrasound; 510(k) K072000
Device Description:
The Xario XG Ultrasound System is a mobile system is a Track 3 device that employs a wide array of probes including, flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.
Intended Use:
The Xario XG is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).
Safety Considerations:
This device is designed and manufactured in conjunction with the Quality System Regulation, IEC 60601-1 (applicable portions), IEC 60601-1-2 (applicable portion), IEC60601-2-37 (applicable portions), and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard.
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
27 2 2 2 2
Toshiba America Medical System, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K072918
Trade/Device Name: Xario XG SSA-680A Version 1.0 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, and ITX Dated: October 11, 2007 Received: October 15, 2007
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 Xario XG SSA-680A Version 1.0, as described in your premarket notification:
Transducer Model Number
PVT-375BT PVT-661VT PLT-1202S PC-20M PET-510MB PST-25BT PVT-575MV
{2}------------------------------------------------
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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information. including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain . other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
{3}------------------------------------------------
If you have any questions regarding the content of this letter, please contact Lauren Hefner at . (240) 276-3666.
Sincerely yours,
Vorque M. Whay
fo Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
System X Transducer Model_Xario XG SSA-680A Version 1.0 510(k) Number(s)
| Clinical Application | B | THI | M | ColorDoppler | Power | DynamicFlow | TDI | PW | CW | CHI2D | CHIDynamicFlow | Combined(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||||
| Fetal | N | N | N | N | N | N | N | N | N | |||
| Abdominal | N | N | N | N | N | N | N | N | N | N | ||
| Intraoperative (Specify) | N | N | N | N | N | N | N | |||||
| IntraoperativeNeurological | ||||||||||||
| Pediatric | N | N | N | N | N | N | N | N | N | N | ||
| Small Organ (Specify)* | N | N | N | N | N | N | N | |||||
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N | ||
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N | ||
| Cardiac | N | N | N | N | N | N | N | N | N | N | N | |
| Transesophageal | N | N | N | N | N | N | N | N | ||||
| Transrectal | N | N | N | N | N | N | N | N | N | |||
| Transvaginal | N | N | N | N | N | N | N | N | N | |||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | N | ||||
| Laparoscopic | ||||||||||||
| Musculo-skeletalSuperficial | N | N | N | N | N | N | N | |||||
| Musculo-skeletalConventional | N | N | N | N | N | N | N |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/RWD: BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF; FEI/BDF
- : For example: thyroid, parathyroid, breast, scrotum and penis
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-off)
Division of Reproductive, Abdominal
Radiological Devices
510(k) Number K0729
A-4
{5}------------------------------------------------
Transducer _X System _
PVT-375BT Model_ 510(k) Number(s)
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | THI | M | ColorDoppler | Power | DynamicFlow | TDI | PW | CW | CHI2D | CHIDynamicFlow | Combined(Specify) |
| Ophthalmic | ||||||||||||
| Fetal | P | P | P | P | P | P | P | P | P | |||
| Abdominal | P | P | P | P | P | P | P | P | P | |||
| Intraoperative (Specify) | ||||||||||||
| IntraoperativeNeurological | ||||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P | |||
| Small Organ (Specify)* | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | ||||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Superficial | ||||||||||||
| Musculo-skeletalConventional |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Previously Cleared 510(k): K072000
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEBDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Amne 7. Wz
Division of Reproductive, Abdomina Radiological Device 510(k) Number
{6}------------------------------------------------
Transducer X System __
PVT-661VT_ Model_ 510(k) Number(s)
D-T6 (m) T-mine T2 (-)
| Mode of Operation | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | THI | M | ColorDoppler | Power | DynamicFlow | TDI | PW | CW | CHI2D | CHIDynamicFlow | Combined(Specify) | |
| Ophthalmic | |||||||||||||
| Fetal | |||||||||||||
| Abdominal | |||||||||||||
| Intraoperative (Specify) | |||||||||||||
| IntraoperativeNeurological | |||||||||||||
| Pediatric | |||||||||||||
| Small Organ (Specify)* | |||||||||||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Cardiac | |||||||||||||
| Transesophageal | |||||||||||||
| Transrectal | P | P | P | P | P | P | P | P | |||||
| Transvaginal | P | P | P | P | P | P | P | P | |||||
| Transurethral | |||||||||||||
| Intravascular | |||||||||||||
| Peripheral Vascular | |||||||||||||
| Laparoscopic | |||||||||||||
| Musculo-skeletalSuperficial | |||||||||||||
| Musculo-skeletalConventional |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD
Previously Cleared 510(k): K072000
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Aonald M. White
{7}------------------------------------------------
Transducer X System _ PLT-1202S Model
510(k) Number(s)
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | THI | M | ColorDoppler | Power | DynamicFlow | TDI | PW | CW | CHI2D | CHIDynamicFlow | Combined(Specify) |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | P | P | ||||||||||
| Intraoperative (Specify) | P | P | P | P | P | P | P | |||||
| IntraoperativeNeurological | ||||||||||||
| Pediatric | P | P | ||||||||||
| Small Organ (Specify)* | P | P | P | P | P | P | P | |||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | |||||
| Laparoscopic | ||||||||||||
| Musculo-skeletalSuperficial | P | P | P | P | P | P | P | |||||
| Musculo-skeletalConventional | P | P | P | P | P | P | P |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD
Previously Cleared 510(k): K072000
(PLEASE DO NOT WRITE BELOW THIS LINE · CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
louis m. why
ductive. Abdominal a
A-7
{8}------------------------------------------------
Transducer X System _
Model_ PC-20M
510(k) Number(s)
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | THI | M | Color Doppler | Power | Dynamic Flow | TDI | PW | CW | CHI 2D | CHI Dynamic Flow | Combined (Specify) |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intraoperative (Specify) | ||||||||||||
| Intraoperative | ||||||||||||
| Neurological | ||||||||||||
| Pediatric | P | |||||||||||
| Small Organ (Specify)* | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | P | |||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | P | |||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Superficial | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Conventional |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments:
Previously Cleared 510(k): K072000
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Aslon Sign-Off) Division of Reproductive, Abdominal and Radlological Devices 510(k) Number
A-8
{9}------------------------------------------------
Transducer X System _ PET-510MB
Model_ 510(k) Number(s)
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | THI | M | ColorDoppler | Power | DynamicFlow | TDI | PW | CW | CHI2D | CHIDynamicFlow | Combined(Specify) |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intraoperative (Specify) | ||||||||||||
| IntraoperativeNeurological | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify)* | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Transesophageal | P | P | P | P | P | P | P | P | ||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | ||||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Superficial | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Conventional |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD;
Previously Cleared 510(k): K072000
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Aorry M. Wly
bdominal and GA BE REDFE
{10}------------------------------------------------
Transducer _X System _ PST-25BT Model 510(k) Number(s)
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | THI | M | ColorDoppler | Power | DynamicFlow | TDI | PW | CW | CHI2D | CHIDynamicFlow | Combined(Specify) |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | P | P | P | P | P | P | P | P | P | P | ||
| Intraoperative (Specify) | ||||||||||||
| IntraoperativeNeurological | ||||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P | P | ||
| Small Organ (Specify)* | ||||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | |||
| Adult Cephalic | P | P | P | P | P | P | P | P | P | |||
| Cardiac | P | P | P | P | P | P | P | P | P | P | ||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | ||||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Superficial | ||||||||||||
| Musculo-skeletalConventional |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF;
Previously Cleared 510(k): K072000
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Harry M. Whay
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{11}------------------------------------------------
System __ Transducer X
PVT-575MV Model_ 510(k) Number(s)
STO(k) Number(s)
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | THI | M | ColorDoppler | Power | DynamicFlow | TDI | PW | CW | CHI2D | CHIDynamicFlow | Combined(Specify) |
| Ophthalmic | ||||||||||||
| Fetal | P | P | P | P | P | P | P | P | ||||
| Abdominal | ||||||||||||
| Intraoperative (Specify) | ||||||||||||
| IntraoperativeNeurological | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify)* | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | ||||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletalSuperficial | ||||||||||||
| Musculo-skeletalConventional |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Previously Cleared 510(k): K072000
(PLEASE DO NOT WRITE BEILOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(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.