(166 days)
Ultrasonic pulsed echo imaging and measurement for fetal imaging and other abdominal as well as pediatric, small organ, neonatal cephalic, adult cephalic, and heart.
Model CTS-310B is a linear/convex electronic scanning ultrasonotomograph with a built-in digital scan converter (DSC). The unit allows heart, abdominal organic and fetal tomographic images to be observable on a video monitor. The main unit is portable and is separable from other equipment to be carried for its use at another place as well as being usable in combination with a 9-inch video monitor and a special photographic unit.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SIUI CTS-310B Ultrasound Imaging System, structured according to your request.
Please Note: The provided document is a 510(k) Premarket Notification Summary from 1999. In this type of submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to prove safety and effectiveness through extensive, de novo clinical trials. Therefore, the information typically available for newer AI/SaMD devices (e.g., detailed study designs, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance metrics like AUC, sensitivity, specificity, etc.) is generally not present. The "acceptance criteria" here are mainly a demonstration that the new device's technical specifications match or are similar to the predicate device.
Acceptance Criteria and Device Performance Study for SIUI CTS-310B Ultrasound Imaging System
The acceptance criteria for the SIUI CTS-310B Ultrasound Imaging System and its associated transducers (EZU-PL12 and EZU-PC3A) are based on demonstrating substantial equivalence to a predicate device, the Hitachi Medical Corporation EUB-310 (K862867). The "study" proving this equivalence is a direct technical comparison.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the specifications of the predicate device (Hitachi EUB-310A). The SIUI CTS-310B is deemed to meet these criteria by demonstrating identical or comparable performance across various technical characteristics.
| Feature | Acceptance Criteria (Predicate: Hitachi EUB-310A) | Reported Device Performance (SIUI CTS-310B) | Meets Criteria? |
|---|---|---|---|
| Main Unit | |||
| Scanning Mode | Electronic linear scanning (compatible 80 elements linear probe); Electronic convex sector (compatible convex probe of 80 elements) | Electronic linear scanning (compatible 80 elements linear probe); Electronic convex sector (compatible convex probe of 80 elements) | Yes |
| Display Mode | B mode, B/B mode, M mode, B/M mode simultaneously | B mode, B/B ode, M mode, B/M mode simultaneously | Yes |
| Measurement | In B mode: distance, area, circumference; In M mode: time interval, velocity, depth, heart rate | In B mode: distance, area, circumference; In M mode: time interval, velocity, depth, heart rate | Yes |
| Calculation | Area, circumference, volume, heart rate, pregnant weeks, heart function | Area, circumference, volume, heart rate, pregnant weeks, heart function | Yes |
| Focusing Mode | 4-steps dynamic focusing with variable aperture and lens focusing | 4-steps dynamic focusing with variable aperture and lens focusing | Yes |
| Scanning Width (3.5MHz probe) | Linear: 104mm (3.5MHz probe) | Linear: 104mm (3.5MHz probe) | Yes |
| Scanning Width (5MHz probe) | Linear: 61mm (5MHz probe) | Linear: 61mm (5MHz probe) | Yes |
| Scanning Angle (Convex Sector) | 60° (convex sector scanning probe) | 60° (convex sector scanning probe) | Yes |
| Transmitting Voltage | Pulse height 130V | Pulse height 130V | Yes |
| Transmitting Pulse Width (3.5MHz) | 140 μs (3.5MHz) | 140 μs (3.5MHz) | Yes |
| Transmitting Pulse Width (5MHz) | 100 μs (5MHz) | 100 μs (5MHz) | Yes |
| Detecting Depth (3.5MHz) | Maximum depth: 210mm (3.5MHz probe) | Maximum depth: 210mm (3.5MHz probe) | Yes |
| Detecting Depth (5MHz) | Maximum depth: 140mm (5MHz probe) | Maximum depth: 140mm (5MHz probe) | Yes |
| Zoom (3.5MHz) | x1.0, x1.2, x1.5, x2.0 selectable + depth shift | x1.0, x1.2, x1.5, x2.0 selectable + depth shift | Yes |
| Zoom (5MHz) | x1.0, x1.5, x2.0 selectable + depth shift | x1.0, x1.5, x2.0 selectable + depth shift | Yes |
| Frame Rate | Maximum 40 frame/second | Maximum 40 frame/second | Yes |
| Grey Scale | 16 | 16 | Yes |
| Memory | 512 x 512 x 4 bit | 512 x 512 x 4 bit | Yes |
| Coordinate transformation | Monitor can display electronic linear scanning image or convex sector scanning image | Monitor can display electronic linear scanning image or convex sector scanning image | Yes |
| Video Output | PAL or NTSC system TV signal | PAL or NTSC system TV signal | Yes |
| Power Supply | 100V, 110V, 117V, 200V, 220V or 234V, ±10%, 50/60Hz, about 250W | 100V, 110V, 117V, 200V, 220V or 234V, ±10%, 50/60Hz, about 250W | Yes |
| Monitor | 5.5" and 9" black and white monitor | 9" black and white monitor (Note: SIUI only mentions 9", Hitachi offers both 5.5" and 9". This is not a deviation that would affect substantial equivalence in operation.) | Comparable |
| Volume and Weight | 405(W) X 710(1) X 1310(h)mm, approx. 40kg | 395 (W) x 1180 (H) x 728 (L)mm, approx. 65 kg (Note: Physical dimensions and weight differ, but this is not typically a performance-based acceptance criterion for image quality or safety for substantial equivalence.) | Comparable |
| Cursor Shift | By joystick on keyboard | By trackball on keyboard (Note: Different interface, but achieves same function. Not a performance or safety issue.) | Comparable |
| Electrical Safety Standard | Conform to requirement of I class B type apparatus of IEC 601-1; Isolate resistor testing: 1000V L-L, L-G ≥ 10MΩ; Leakage current: U*-G≤500μA, P-G≤100μA; Voltage resistance testing: L-G, P-G 1500V 2mA, no sparking or arcing in 1 minute; Work normally when voltage changes ± 10% | Conform to requirement of I class B type apparatus of IEC 601-1 isolate resistor testing: 1000V L-L, L-G ≥ 10MΩ; Leakage current: U*-G≤500μA, P-G≤100μA; Voltage resistance testing: L-G, P-G 1500V 2mA, no sparking or arcing in 1 minute; Work normally when voltage changes ± 10% | Yes |
| Probe Ultrasound | |||
| EZU-PL12 (Transmitting Freq) | 5MHz (Hitachi EZU-PL12) | 5MHz (SIUI EZU-PL12) | Yes |
| EZU-PL12 (Scanning Width) | 61mm (Hitachi EZU-PL12) | 61mm (SIUI EZU-PL12) | Yes |
| EZU-PC3A (Transmitting Freq) | 3.5MHz (Hitachi EZU-PC3A) | 3.5MHz (SIUI EZU-PC3A) | Yes |
| EZU-PC3A (Scanning Angle) | 60° (Hitachi EZU-PC3A) | 60° (SIUI EZU-PC3A) | Yes |
| Operation Environment | Temperature 5-40°C, relative humidity 30-85% (no water drop) | Temperature 5-40°C, relative humidity 30-85% (no water drop) | Yes |
| Storage Environment | Temperature -10-60°C, relative humidity 30-95% (no water drip) air pressure 700-1060mB | Temperature -10-60°C, relative humidity 30-95% (no water drop) air pressure 700-1060mB | Yes |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: This submission does not describe a clinical test set in the way a modern AI/SaMD submission would. The "test" for substantial equivalence is primarily a technical comparison of specifications and intended use against a legally marketed predicate device. No patient data or image datasets are mentioned as being used for testing.
- Data Provenance: Not applicable, as no clinical test set data is described. The comparison is based on the published technical specifications of the predicate device (Hitachi EUB-310A) and the manufacturer's own specifications for the SIUI CTS-310B, along with a demonstration of compliance with relevant electrical safety standards (IEC 601-1).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. No "ground truth" establishment using experts or patient data for a test set is described in this 510(k) submission. Substantial equivalence relies on comparing technical specifications and intended use.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is a 1999 510(k) for a conventional ultrasound system, not an AI/SaMD. Such studies are not part of the substantial equivalence pathway for this type of device.
6. Standalone (i.e. algorithm only without human-in-the loop performance) Study
- Not applicable. This device is a diagnostic ultrasound system operated by a human, not an algorithm providing standalone interpretations.
7. Type of Ground Truth Used
- Not applicable in the context of an AI/SaMD. For this ultrasound system, the "ground truth" for demonstrating substantial equivalence is the set of established technical specifications and performance characteristics of the predicate device. The SIUI CTS-310B's own technical specifications were compared against these.
8. Sample Size for the Training Set
- Not applicable. This is not an AI/SaMD. No machine learning training set is involved.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as no training set is described.
Summary of the "Study" for Substantial Equivalence:
The "study" conducted for the SIUI CTS-310B Ultrasound Imaging System to meet acceptance criteria was a technical comparison against a predicate device, the Hitachi EUB-310A. The manufacturer presented detailed technical specifications for their device and demonstrated that these specifications were either identical or acceptably comparable to those of the predicate. This comparison supported the claim that the new device has the same fundamental scientific technology, materials, design, safety features, and performance characteristics, and the same intended use as the predicate device, thus establishing "substantial equivalence" as required for 510(k) clearance by the FDA. The "acceptance criteria" were met by showing that the proposed device performed within the operational and technical parameters established by the predicate. Regulatory compliance for electrical safety (IEC 601-1) was also a critical component.
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KG84161
韶声仪器研究
5 1999 MAY
Tab 11
Premarket Notification [510(k)] Summary
September 7,1998
CTS-310B with EZU-PL12 and EZU-PC3A Transducers Trade Name:
Diagnostic Ultrasound System Common Name:
Ultrasonic Pulsed Echo Imaging System, 90 IYO Classification Name:
(per 21 CFR section 892.1560)
Shantou Institute of Ultrasonic Instruments
Manufacturer's Name:
Address:
Shantou Sez, 515041, China
#2, Jinsha Road, M.,
Corresponding Official: Mr. Jinzhong Yao
Title: President
Fax: (86) 754-8251499 Telephone: (86) 754-8250150
Predicate: Hitachi Medical Corporation EUB-310, K862867
Device Description: Model CTS-310B is a linear/convex electronic scanning ultrasonotomograph with a built-in digital scan converter (DSC). The unit allows heart, abdominal organic and fetal tomographic images to be observable on a video monitor. The main unit is portable and is separable from other equipment to be carried for its use at another place as well as being usable in combination with a 9-inch video monitor and a special photographic unit.
Intended Use: Ultrasonic pulsed echo imaging and measurement for fetal imaging and other abdominal as well as pediatric, small organ, neonatal cephalic, adult cephalic, and heart.
Technological Characteristics: See the attached "Comparison List" of the SIUI CTS-310B and the Hitachi EUB-310.
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COMPARIS ON LIST OF SIUI PRODUCT AND HITACHI PRODUCT
| Performance | CTS-310 (SIUI) | EUB-310A (HITACHI) | |
|---|---|---|---|
| mainunit | scanningmode | electronic linear scanning(compatible 80 elements linear probe) electronic convex sector(compatible convex probe of 80 elements) | electronic linear scanning(compatible 80 elements linear probe) electronic convex sector(compatible convex probe of 80 elements) |
| display mode | B mode B/B ode, M mode, B/M modesimultaneously | B mode, B/B mode, M mode, B/Mmode simultaneously | |
| measure-ment | in B mode display: distance, areaand circumferencein M mode display: time interval,velocity, depth and heart rate | in B mode display: distance, areaand circumferencein M mode display: time interval,velocity, depth and heart rate | |
| calculation | area, circumference, volume, heartrate, pregnant weeks and heartfunction | area, circumference, volume, heartrate, pregnant weeks and heartfunction | |
| focusingmode | 4-steps dynamic focusing withvariable aperture and lens focusing | 4-steps dynamic focusing withvariable aperture and lens focusing | |
| scanningwidth | linear scanning: 3.5MHz probe104mm, 5MHz probe 61mmconvex sector scanning probe:sector angle 60° | linear scanning: 3.5MHz probe104mm, 5MHz probe 61mmconvex sector scanning probe:sector angle 60° | |
| transmittingvoltage | pulse height 130V | pulse height 130V | |
| transmittingpulse width | 3.5MHz pulse width 140 μs5MHz pulse width 100 μs | 3.5MHz pulse width 140 μs5MHz pulse width 100 μs | |
| detectingdepth | 3.5MHz probe maximum depth:210mm5MHz probe maximum depth:140mm | 3.5MHz probe maximum depth:210mm5MHz probe maximum depth:140mm | |
| zoom | 3.5MHz probe: x1.0, x1.2, x1.5, x2.0selectable as well as depth shift5MHz probe: x1.0, x1.5, x2.0selectable as well as depth shift | 3.5MHz probe: x1.0, x1.2, x1.5, x2.0selectable as well as depth shift5MHz probe: x1.0, x1.5, x2.0selectable as well as depth shift | |
| frame rate | the maximum is 40 frame / second | the maximum is 40 frame / second | |
| grey scale | 16 | 16 | |
| memory | 512 x 512 x 4 bit | 512 x 512 x 4 bit | |
| coordinatetransforma-tion function | monitor can display electronic linearscanning image or convex sectorscanning image | monitor can display electronic linearscanning image or convex sectorscanning image | |
| Performance | CTS-310 (SIUI) | EUB-310A (HITACHI) | |
| mainunit | video output | PAL or NTSC system TV signal(confirmed in order) | PAL or NTSC system TV signal(confirmed in order) |
| power supply | 100V, 110V, 117V, 200V, 220V or234V, ±10%, 50/60Hz, about250W | 100V, 110V, 117V, 200V, 220V or234V, ±10%, 50/60Hz, about250W | |
| monitor | 9" black and white monitor | 5.5" and 9" black and white monitor | |
| volumeandweight | 395 (W) x 1180 (H) x 728 (L)mmapprox. 65 kg | 405(W) X 710(1) X 1310(h)mmapprox. 40kg | |
| cursor shift | by trackball on keyboard | by joystick on keyboard | |
| electricapparatussaftystandard | conform to requirement of I class Btype apparatus of IEC 601-1 isolateresistor testing: testing voltage1000V L-L, L-G ≥ 10MΩ | conform to requirement of I class Btype apparatus of IEC 601-1 isolateresistor testing: testing voltage1000V L-L, L-G≥10MΩ | |
| leakage current: U*-G≤500μAP-G≤100μA | leakage current: U*-G≤500μAP-G≤100µA | ||
| voltage resistance testing: L-G, P-G1500V 2mA, no sparking or arcing in1 minutework normally when voltage changes± 10% | voltage resistance testing: L-G, P-G1500V 2mA, no sparking or arcing in1 minutework normally when voltage changes± 10% | ||
| probe ultrasound | linear probe: | linear probe: | |
| transmittingfrequency | EZU-PL12 80 elements,5MHzscanning width 61mmEZU-PC3A 80 elements,40R, 3.5MHz | EZU-PL11 80 elements, 3.5MHzscanning width 104mmEZU-PL12 80 elements, 5MHz | |
| 3.5MHz scanning angle 60° | scanning width 61mmEUU-L11S 80 elements, 3.5MHzscanning width 84mmconvex sector probe: EZU-PC3A 80elements, 40R, 3.5MHz, scanningangle 60°EZU-PC2A 80 elements, 40R,5MHz, scanning angle 60°EUP-V12A 40 elements, 40R, 5MHz, | ||
| scanning angle 40° (transvaginalprobe) | |||
| operation | temperature 5-40°C, relative | temperature 5-40 °C, relative | |
| environment | humidity 30-85% (no water drop) | humidity 30-85% (no water drop) | |
| storage environment | temperature -10-60°C, relativehumidity 30-95% (no water drop) airpressure 700-1060mB | temperature -10-60°C, relativehumidity 30-95% (no water drip) airpressure 700-1060mB | |
| note |
{2}------------------------------------------------
COMPARIS ON LIST OF SIUI PRODUCT AND HITACHI PRODUCT
*U means main unit.
:
{3}------------------------------------------------
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
MAY 5 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shantou Institute of Ultrasonic Instruments C/O Robert J. Morton, M.S. President & Certified Radiological Physicist Quality & Regulatory Services 1106 Chiltern Drive Walnut Creek, California 94596
Re: K984161 SIUI CTS-310B Ultrasound Imaging System Dated: April 1, 1999 Received: April 5, 1999 Regulatory Class: II 21 CFR 892.1560/Procode: 90 IYO
Dear Mr. Morton:
We have reviewed your Section 510(k) 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 SIUI CTS-310B Ultrasound Imaging System, as described in your premarket notification:
Transducer Model Number
EZU-PL12 EZU-PC3A
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{4}------------------------------------------------
Page -2 - Mr. Morton
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo Perez at (301) 594-1212.
Sincerely yours,
Orind be. Seymon
for
CAPT Daniel B. Sch ltz, M.D. Acting Director Division of Reproductive,
Abdominal, Ear, Nose and Throat, And Radiological Devices Office of Device Evaluation Center for Devices and Radiological Devices
Enclosure(s)
{5}------------------------------------------------
Page 2 Re: K984161 SIUI CTS-310B Ultrasound Imaging System
Diagnostic Ultrasound Indications for Use Form Device Name: SIUI CTS-310B
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) |
|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||
| Fetal | N | N | N | ||||||
| Abdominal | N | ||||||||
| Intraoperative (specify) | |||||||||
| IntraoperativeNeurological | |||||||||
| Pediatric | N | N | N | ||||||
| Small Organ (specify) | N | ||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | N | N | N | ||||||
| Transesophageal | |||||||||
| Transrectal | |||||||||
| Transvaginal | |||||||||
| Transurethrat | |||||||||
| Intravascular | |||||||||
| Peripheral Vascular | |||||||||
| Laparoscopic | |||||||||
| Musculo-skeletalConventional | |||||||||
| Musculo-skeletalsuperficial | |||||||||
| Other (specify) |
N=new indication
Additional Comments: thyroid gland, breast, testes____________________________________________________________________________________________________________________________
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, office of Device Evaluation (ODE)
Yhrist A. Lezon
(Division Sign-Off)
Prescription Use (Per 21 CFR 801.109)
Division of Reproductive, Abdominal, ENT, and Radiological I
510(k) Number K984110
{6}------------------------------------------------
Scanhead Indications for Use Form Device Name: EZU-PL12
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | ||
| Ophthalmic | |||||||||||
| Fetal | N | N | |||||||||
| Abdominal | N | ||||||||||
| Intraoperative (specify) | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | N | ||||||||||
| Small Organ (specify) | N | ||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethrat | |||||||||||
| Intravascular | |||||||||||
| Perpheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalsuperficial | |||||||||||
| Other (specify) |
N = new indication
Additional Comments: thyroid gland, breast, testes____________________________________________________________________________________________________________________________
..............................................................................................................................................................................
Concurrence of CDRH, office of Device Evaluation (ODE)
am
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K984161
{7}------------------------------------------------
Scanhead Indications for Use Form Device Name: EZU-PC3A
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | ||
| Ophthalmic | |||||||||||
| Fetal | N | N | N | ||||||||
| Abdominal | N | ||||||||||
| Intraoperative (specify) | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | N | N | N | ||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | N | N | N | ||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethrat | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalsuperficial | |||||||||||
| Other (specify) | |||||||||||
| N = new indicationAdditional Comments: |
Concurrence of CDRH, office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K984161
Devices
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.