(31 days)
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional, Transrectal.
The SDU-1100 is a mobile diagnostic ultrasound system. This system has flat linear array, convox array, and sector probe with a frequency range of approximately 2 to 15 MHz. The system can operate in B mode, M mode, Pulsed Doppler mode, Color mode, or in a combination of modes.
The provided text describes a 510(k) premarket notification for the SHIMADZU MEDICAL SYSTEMS SDU-1100 Ultrasound Imaging System. This document generally focuses on establishing substantial equivalence to a predicate device based on intended use and safety standards, rather than detailing a specific clinical study with acceptance criteria and performance metrics described in clinical terms (e.g., sensitivity, specificity, accuracy).
Therefore, based solely on the provided text, a comprehensive table of acceptance criteria and proven device performance as typically expected for clinical evaluation studies (e.g., diagnostic accuracy metrics) cannot be extracted. The acceptance criteria in this context are related to meeting established regulatory and safety standards, and demonstrating substantial equivalence for the stated indications for use.
Below is an attempt to structure the available information regarding acceptance criteria and the "study" (which in this case refers to the submission process for substantial equivalence).
Acceptance Criteria and Device Performance (Based on provided 510(k) Summary)
The "acceptance criteria" for the SDU-1100, as presented in this 510(k) submission, are primarily centered around demonstrating substantial equivalence to a predicate device and adherence to relevant safety and performance standards for ultrasound systems. The "reported device performance" is implicitly that the device meets these standards and is considered safe and effective for its indicated uses.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion Category | Specific Criteria (Derived from 510(k) Summary) | Reported Device Performance (as stated or implied) |
|---|---|---|
| Intended Use Equivalence | The device's intended uses must be substantially equivalent to a legally marketed predicate device. The SDU-1100 is intended for: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial, and Musculo-skeletal Conventional applications. Specific transducers (L040-075U, L072-050U, L040-120U, VA13R-035U, VA13R-050U, VA20R-035U, VA40R-035U, VA40R-035HU, VA57R-0375WU, VA57R-0375HU, TV11R-055U, UB10R-065U) also have defined indications for use across various modes (B, M, PWD, Color Doppler, Power Doppler, Color Velocity Imaging, Combined, Tissue Harmonic Imaging). | The FDA has determined the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This implies the SDU-1100, including its transducers, performs adequately for its stated applications. |
| Technological Characteristics | The device must have technological characteristics (e.g., modes of operation: B, M, Pulsed Doppler, Color mode; transducers with specific frequency ranges of approximately 2 to 15 MHz) that are substantially equivalent to a predicate device, or where differences do not raise new questions of safety or effectiveness. | The FDA's substantial equivalence determination implies that the technological characteristics of the SDU-1100 are considered equivalent to the predicate device (GE Logiq 500, K991611) for the stated intended uses. |
| Safety and Performance Standards Adherence | The device must meet recognized voluntary and measurement standards for medical electric equipment, acoustic output, and real-time display of thermal and mechanical acoustic output indices. Specifically: | The device "has been designed to meet the following voluntary and measurement standards," and FDA clearance is based on this assertion, with a post-clearance special report requested to verify acoustic output measurements based on production line devices. This implies the device is deemed to meet these standards. |
| - IEC 60601-1 Safety of Medical Electric Equipment | ||
| - AIUM NEMA UD2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment | ||
| - Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment Revision 1 (AIUM 1998) | ||
| - AIUM NEMA UD3 Standard for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment | ||
| Post-Clearance Acoustic Output Verification | Prior to shipping the first device, a post-clearance special report containing complete information, including acoustic output measurements based on production line devices, as requested in Appendix G of the Center's September 30, 1997 "Information for Manufacturers of Diagnostic Ultrasound Systems and Transducers." | This is a condition for clearance, to be met post-clearance. The clearance is granted "on the condition that prior to shipping the first device, you submit a postclearance special report" to confirm approved acoustic output levels. |
2. Sample size used for the test set and the data provenance
The provided 510(k) summary does not mention a specific test set, sample size, or clinical data provenance (e.g., country of origin, retrospective/prospective). 510(k) submissions for general ultrasound imaging systems typically rely on technical performance data, adherence to standards, and comparison to a predicate device rather than extensive new clinical studies to demonstrate diagnostic accuracy through a "test set" in the way a novel diagnostic algorithm might. The "study" here is the submission that demonstrates substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the 510(k) summary. Given that it's a submission for a general ultrasound imaging system, the "ground truth" is typically defined by existing medical consensus, established imaging protocols, and the performance characteristics of the predicate device. Clinical trials with expert-adjudicated ground truth are not typically a primary component of a 510(k) for this type of device unless new and complex claims are being made.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as the document does not describe a clinical study involving a test set needing expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This type of study is not mentioned in the provided document. The SDU-1100 is described as a diagnostic ultrasound imaging system, not an AI-powered diagnostic assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the SDU-1100 is a hardware imaging device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" for substantial equivalence is generally based on:
- Established performance of the predicate device: The GE Logiq 500 (K991611).
- Compliance with recognized industry standards: IEC 60601-1, AIUM NEMA UD2, AIUM 1998 Acoustic Output Measurement and Labeling Standard, AIUM NEMA UD3. These standards define acceptable levels of safety and performance.
- Bio-compatibility and electrical safety testing: Implied by adherence to IEC 60601-1.
- Technical specifications and engineering data: Used to demonstrate that the device functions as intended and within safe limits (e.g., acoustic output).
8. The sample size for the training set
This is not applicable as the document describes a hardware device submission, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as #8.
{0}------------------------------------------------
K0505/0
510(k) Summary
1.0 SUBMITTER INFORMATION
SHIMADZU MEDICAL SYSTEMS 1.1 Submitter: 20101 South Vermont Ave. Torrance, CA 90502-1328 PH: 310-217-8855 FX: 310-217-8869
Randal Walker 1.2 Contact:
- January 18, 2005 1.3 Date:
2.0 DEVICE NAME
| 2.1 Proprietary Name: | SDU-1100 |
|---|---|
| 2.2 Common Name: | Ultrasound Imaging System |
| 2.3 Classification: | Ultrasonic Pulsed Doppler Imaging SystemFR # 892.1550, Product Code 90-IYNUltrasonic Pulsed Echo Imaging SystemFR # 892.1560, Product Code 90-IYODiagnostic Ultrasound TransducerFR # 892.1570, Product Code 90-ITX |
| 2.4 Predicate Device: | GE Logiq 500 (K991611, 6/9/99) |
3.0 DEVICE DESCRIPTION
DE VICE DESCREF TTO!"
The SDU-1100 is a mobile diagnostic ultrasound system. This system has flat linear The SDO Trooms and sector probe with a frequency range of approximately 2 to 15 array, convox mode, M mode, Pulsed Doppler mode, Color mode, or in a combination of modes.
4.0 INTENDED USE
The SDU-1100 is intended for the following applications:
{1}------------------------------------------------
Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional.
5.0 SAFETY CONSIDERATIONS
SDU-1100 has been designed to meet the following voluntary and measurement standards:
- . IEC 60601-1 Safety of Medical Electric Equipment
- AIUM NEMA UD2 Acoustic Output Measurement Standard for Diagnostic . Ultrasound Equipment
- Acoustic Output Measurement and Labeling Standard for Diagnostic . Ultrasound Equipment Revision 1 (AIUM 1998)
- . AIUM NEMA UD3 Standard for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 1 2005
Mr. Randal Walker National Service Manager Shimadzu Medical Systems 20101 South Vermont Avenue TORRANCE CA 90502
Re: K050510
Trade Name: SDU-1100 (Echo View/Shimasonic) Diagnostic Ultrasound Device Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: January 18, 2005 Received: March 1, 2005
Dear Mr. Walker:
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 SDU-1100 (Echo View/Shimasonic) Diagnostic Ultrasound Device, as described in your premarket notification:
Transducer Model Number
| L040-075U | L072-050U |
|---|---|
| L040-120U | VA13R-035U |
| L070-075U | VA13R-050U |
{3}------------------------------------------------
| VA20R-035U | VA57R-0375HU |
|---|---|
| VA40R-035U | TV11R-055U |
| VA40R-035HU | UB10R-065U |
| VA57R-0375WU |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your do received 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 r least of a 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 or uny 1 outher 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 forth in the quand byovisions (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 m rippendines of the counce 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 If you desire specific at not 10. Jose (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain
{4}------------------------------------------------
Page 2 - Mr.Walker
other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 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 Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{5}------------------------------------------------
Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement
Page 1 _ of _ 14
510(k) Number (if known) : 510(K) Namber (II known) : Ultrasound System SDU-1100, system
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify)** | Tissue Harmonic Imaging | Other (Specify) |
| Ophthalmic | |||||||||||
| Fetal | N | N | N | N | N | N | N | N | |||
| Abdominal | N | N | N | N | N | N | N | N | |||
| Intra-operative (Specify) | |||||||||||
| Intra-operative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (Specify) * | N | N | N | N | N | N | N | N | |||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | N | N | N | N | N | N | N | N | |||
| Transesophageal | |||||||||||
| Transrectal | N | N | N | N | N | N | N | N | |||
| Transvaginal | N | N | N | N | N | N | N | N | |||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | N | |||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | |||
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | |||
| Other (Specify) |
Mode of Operation
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
- Thyroid, Testicles, Breast
** B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Nancy bradom
(Division Sign-Off)
Division of and Radiological Device 510(k) Number
{6}------------------------------------------------
Prescription Use (Per 21 CFR 801.109) Page 2 of _ 14 Ultrasound Device Indications Statement
510(k) Number (if known) : 510(K) Numoci (II Known) :
Device Name : Diagnostic Ultrasound System SDU-1100, L040-075U
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify)** | TissueHarmonicImaging | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intra-operative(Specify) | |||||||||||
| Intra-operativeNeurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ(Specify) * | N | N | N | N | N | N | N | N | N | ||
| Neonatal | |||||||||||
| Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | ||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | N | N | N | N | N | N | N | N | N | ||
| Musculo-skeletalSuperficial | N | N | N | N | N | N | N | N | N | ||
| Other (Specify) |
Mode of Operation
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
-
- Thyroid, Testicles, Breast
** B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)
- Thyroid, Testicles, Breast
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Vance Snagdon
(Division Sign-C Division of Reproductive, Abdon and Radiological Device 510(k) Number
{7}------------------------------------------------
Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 3 _of _ 14
510(k) Number (if known) : 510(K) Number (II Known) .
Device Name : Diagnostic Ultrasound System SDU-1100, L040-120U
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) ** | TissueHarmonicImaging | Other(Specify) | |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative(Specify) | ||||||||||||
| Intra-operativeNeurological | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ(Specify) * | N | N | N | N | N | N | N | N | ||||
| Neonatal | ||||||||||||
| Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | N | ||||
| Laparoscopic | ||||||||||||
| Musculo-skeletalConventional | N | N | N | N | N | N | N | N | ||||
| Musculo-skeletalSuperficial | N | N | N | N | N | N | N | N | ||||
| Others (Specify) |
Mode of Operation
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
- Thyroid, Testicles, Breast
** B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)
Conversion Algae
(Division Sign-Off)
Nancy Brandon
Division of Reproductive and Radiological Device 510(k) Number
{8}------------------------------------------------
Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 4_of __ 14
510(k) Number (if known) : 510(K) Name : Diagnostic Ultrasound System SDU-1100, L070-075U
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) ** | TissueHarmonicImaging | Other(Specify) | |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative(Specify) | ||||||||||||
| Intra-operativeNeurological | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ(Specify) * | N | N | N | N | N | N | N | N | ||||
| NeonatalCephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | N | ||||
| Laparoscopic | ||||||||||||
| Musculo-skeletalConventional | N | N | N | N | N | N | N | N | ||||
| Musculo-skeletalSuperficial | N | N | N | N | N | N | N | N | ||||
| Others (Specify) |
ode of Oneration
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
- Thyroid, Testicles, Breast
** B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)
Criminology Class
✓
Nancy C. Brigdon
(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number
{9}------------------------------------------------
Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 5 of 14
510(k) Number (if known) : 510(K) Name : Diagnostic Ultrasound System SDU-1100, L072-050U
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify)** | TissueHarmonicImaging | Other(Specify) | |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative(Specify) | ||||||||||||
| Intra-operativeNeurological | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ(Specify) * | N | N | N | N | N | N | N | N | ||||
| Neonatal | ||||||||||||
| Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | N | ||||
| Laparoscopic | ||||||||||||
| Musculo-skeletalConventional | N | N | N | N | N | N | N | N | ||||
| Musculo-skeletalSuperficial | ||||||||||||
| Others (Specify) |
Ennoration
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
- Thyroid, Testicles, Breast
** B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)
$\checkmark$
Nancy C. Bradden
(Division Sign-Off) Division of Reproductive, Abdon and Radiological Device 510jk) Number
{10}------------------------------------------------
Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 6 _ of _ 14
510(k) Number (if known) : 510(K) Number (11 Kilowil) ·
Device Name : Diagnostic Ultrasound System SDU-1100, VA13R-035U
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify)** | TissueHarmonicImaging | Other(Specify) |
| Ophthalmic | |||||||||||
| Fetal | N | N | N | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | N | N | N | ||
| Intra-operative(Specify) | |||||||||||
| Intra-operativeNeurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ(Specify) * | |||||||||||
| Neonatal | |||||||||||
| Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | N | N | N | N | N | N | N | N | N | ||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Others (Specify) |
Mode of Operation
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M)
Nancy C. Broadson
(Division Sign-Off) Division of Reproductive, Abdomit and Radiological Devices 510(k) Number
{11}------------------------------------------------
Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 7 _ of __ 14 _
510(k) Number (if known) : 310(K) Name : Diagnostic Ultrasound System SDU-1100, VA13R-050U
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) ** | TissueHarmonicImaging | Other(Specify) |
| Ophthalmic | |||||||||||
| Fetal | N | N | N | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | N | N | N | ||
| Intra-operative(Specify) | |||||||||||
| Intra-operativeNeurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ(Specify) * | |||||||||||
| NeonatalCephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | N | N | N | N | N | N | N | N | |||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Others (Specify) |
Mode of Operation
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M)
/
Nancy Choadon
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number _
{12}------------------------------------------------
Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 8 of 14
510(k) Number (if known) : 510(K) Number (II Khown) ·
Device Name : Diagnostic Ultrasound System SDU-1100, VA20R-035U
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify)** | TissueHarmonicImaging | Other(Specify) | |
| Ophthalmic | ||||||||||||
| Fetal | N | N | N | N | N | N | N | N | ||||
| Abdominal | N | N | N | N | N | N | N | N | ||||
| Intra-operative(Specify) | ||||||||||||
| Intra-operativeNeurological | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ(Specify) * | ||||||||||||
| NeonatalCephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | N | N | N | N | N | N | N | N | ||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | ||||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletalConventional | ||||||||||||
| Musculo-skeletalSuperficial | ||||||||||||
| Others (Specify) |
of Oneration
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M)
Nancy C Hogdon
(Division Sign-Off)
Division of Reproductive, Abdon and Radiological Devices 5 10(k) Number
{13}------------------------------------------------
Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 9 of _ 14
510(k) Number (if known) : 510(K) Name : Diagnostic Ultrasound System SDU-1100, VA40R-035U
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) ** | TissueHarmonicImaging | Other(Specify) |
| Ophthalmic | |||||||||||
| Fetal | N | N | N | N | N | N | N | N | |||
| Abdominal | N | N | N | N | N | N | N | N | |||
| Intra-operative(Specify) | |||||||||||
| Intra-operative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ(Specify) * | |||||||||||
| Neonatal | |||||||||||
| Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Others (Specify) |
Mode of Oneration
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M)
$\checkmark$
Nancy C. hogdon
(Division Sign Off) Division of Reproductive, Abdo and Radiological Devices 5 10(k) Number
{14}------------------------------------------------
Prescription Use (Per 21 CFR 801.109) Page _ 10_ of _ 14 Ultrasound Device Indications Statement
510(k) Number (if known) : 510(K) Name : Diagnostic Ultrasound System SDU-1100, VA40R-035HU
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) ** | TissueHarmonicImaging | Other(Specify) |
| Ophthalmic | |||||||||||
| Fetal | N | N | N | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | N | N | N | ||
| Intra-operative(Specify) | |||||||||||
| Intra-operativeNeurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (Specify) * | |||||||||||
| Neonatal | |||||||||||
| Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Others (Specify) |
Mode of Operation
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M)
Nancy C. Hogdon
(Division Sigh-Off) Division of Reproductive, Abdominal, ഒരു പ്രവേശ്വാcal Devices ി
{15}------------------------------------------------
Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page _ 11_ of _ 14
510(k) Number (if known) : 510(K) Number (11 Khowil) .
Device Name : Diagnostic Ultrasound System SDU-1100, VA57R-0375WU
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) ** | TissueHarmonicImaging | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||||
| Fetal | N | N | N | N | N | N | N | N | |||
| Abdominal | N | N | N | N | N | N | N | N | |||
| Intra-operative(Specify) | |||||||||||
| Intra-operative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ(Specify) * | |||||||||||
| Neonatal | |||||||||||
| Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Others (Specify) |
ode of Oneration
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M)
$\checkmark$
Nancy L. Tharpion
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(K) Number K0505
{16}------------------------------------------------
Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page _ 12_of __ 14__
510(k) Number (if known) : 510(K) Number (11 khowil) · Litrasound System SDU-1100, VA57R-0375HU
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify)** | TissueHarmonicImaging | Other(Specify) |
| Ophthalmic | |||||||||||
| Fetal | N | N | N | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | N | N | N | ||
| Intra-operative(Specify) | |||||||||||
| Intra-operativeNeurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ(Specify) * | |||||||||||
| Neonatal | |||||||||||
| Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Others (Specify) |
Mode of Operation
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brazdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
adiological Devices
K Number
K05
300(k) Number _
{17}------------------------------------------------
Prescription Use (Per 21 CFR 801.109) Page _ 13_ of _ 14 Ultrasound Device Indications Statement
510(k) Number (if known) : 510(K) Number (II Khowi) · ___________________________________________________________________________________________________________________________________________________
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) ** | TissueHarmonicImaging | Other(Specify) |
| Ophthalmic | |||||||||||
| Fetal | N | N | N | N | N | N | N | N | |||
| Abdominal | |||||||||||
| Intra-operative(Specify) | |||||||||||
| Intra-operative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ(Specify) * | |||||||||||
| Neonatal | |||||||||||
| Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | N | ||||||||||
| Transrectal | N | N | N | N | N | N | N | N | |||
| Transvaginal | N | N | N | N | N | N | N | N | N | ||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Others (Specify) |
Mode of Oneration
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M)
V
Nancy C burton
(Division Sign-Off)(
Division of Reproductive, Abdominal,
and Darkh al Devices
amber
K050510
{18}------------------------------------------------
Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page _14 of 14
510(k) Number (if known) :
510(K) Name : Diagnostic Ultrasound System SDU-1100, UB10R-065U
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) ** | TissueHarmonicImaging | Other(Specify) |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intra-operative(Specify) | |||||||||||
| Intra-operative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ(Specify) * | |||||||||||
| Neonatal | |||||||||||
| Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | N | N | N | N | N | N | N | N | |||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Others (Specify) |
Mode of Operation
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M)
Maneyl beagdon
(Division Sign-Off)
U
of Reproductive, Abdominal,
Radiological Devices
510(k) Number L050510
§ 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.