(175 days)
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Abdominal, Cardiac Adult, Cardiac Pediatric, Fetal, Small Organ (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Peripheral vessel, Trans-rectal, Trans-vaginal. Modes of Operation: A, B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, Color/PWD, B/PWD/M, Color/M and Color/PWD/M mode).
Diagnostic Ultrasound System SDU-2000 with various transducers: 2.5 MHz PA SECTOR, 3.5 MHz PA SECTOR, 5.0 MHz PA SECTOR, 3.5 MHz R40 CA CONVEX, 3.5 MHz R76 CA CONVEX, 7.5 MHz LA LINEAR ARRAY, 5.5 MHZ TV CONVEX.
This document is a 510(k) premarket notification decision letter for the Shimadzu Medical Systems Echo View SDU-2000 Diagnostic Ultrasound System. It outlines the FDA's determination of substantial equivalence and lists the intended uses for various transducers.
Based on the provided text, there is no specific study described that proves the device meets acceptance criteria. The document is a regulatory approval letter, not a clinical study report. It grants permission to market the device based on a determination of substantial equivalence to existing devices, implying that the device is expected to meet certain performance characteristics indirectly through that equivalence.
The letter mentions a "postclearance special report" containing "acoustic output measurements based on production line devices" which implies that further performance data would be collected and submitted after clearance but does not detail acceptance criteria or study results for initial approval.
Therefore, many of the requested details cannot be extracted from this document because it is not a study report.
Here's what can be gathered, with caveats:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document is an FDA clearance letter based on substantial equivalence, not a detailed technical report with performance metrics or acceptance criteria. It focuses on intended uses and regulatory classification.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. No test set or study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document. No information on ground truth establishment or experts is present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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 information is not provided in the document. The device is a diagnostic ultrasound system, not an AI-assisted device, and no MRMC study is described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not provided in the document. The device is a diagnostic ultrasound system, not an algorithm being tested in standalone mode.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not provided in the document.
8. The sample size for the training set:
This information is not provided in the document. No training set is mentioned as this is a traditional medical device, not an AI/ML model for which a training set would typically be described in this context.
9. How the ground truth for the training set was established:
This information is not provided in the document.
Summary of what the document does provide regarding the device:
- Device Name: Echo View SDU-2000 Diagnostic Ultrasound System
- Manufacturer: Shimadzu Medical Systems
- FDA K Number: K970508
- Regulatory Class: II (21 CFR 892.1550/Procode: 90 IYO)
- Date of Clearance: June 20, 1997 (Received June 23, 1997)
- Transducers covered:
- 2.5 MHz PA SECTOR
- 3.5 MHz PA SECTOR
- 5.0 MHz PA SECTOR
- 3.5 MHz R40 CA CONVEX
- 3.5 MHz R76 CA CONVEX
- 7.5 MHz LA LINEAR ARRAY
- 5.5 MHZ TV CONVEX
- Intended Use (General): Diagnostic ultrasound imaging or Doppler analysis of the human body.
- Specific Clinical Applications and Modes (Vary by transducer model, see tables in Input):
- 2.5 MHz PA SECTOR: Abdominal (PWD, Color, Power Doppler), Cardiac Adult (A, B, M, PWD, CWD, Color, Power Doppler, Color Velocity Imaging, Combined), Cardiac Pediatric (A, B, M, PWD, CWD, Color, Power Doppler, Color Velocity Imaging, Combined)
- 3.5 MHz PA SECTOR: Abdominal (PWD, Color, Power Doppler), Cardiac Adult (B, M, PWD, CWD, Color, Power Doppler, Color Velocity Imaging, Combined), Cardiac Pediatric (B, M, PWD, CWD, Color, Power Doppler, Color Velocity Imaging, Combined)
- 5.0 MHz PA SECTOR: Abdominal (PWD, Color, Power Doppler), Cardiac Adult (B, M, PWD, CWD, Color, Power Doppler, Color Velocity Imaging, Combined), Cardiac Pediatric (B, M, PWD, CWD, Color, Power Doppler, Color Velocity Imaging, Combined)
- 3.5 MHz R40 CA CONVEX: Fetal (B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined), Abdominal (A, B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined)
- 3.5 MHz R76 CA CONVEX: Fetal (B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined), Abdominal (B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined)
- 7.5 MHz LA LINEAR ARRAY: Small Organ (A, B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined - specifically Thyroid, Testicles, Breast), Peripheral Vessel (A, B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined)
- 5.5 MHz TV CONVEX: Fetal (B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined), Small Organ (B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined), Trans-rectal (B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined), Trans-vaginal (B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined)
The document is primarily a regulatory clearance indicating the device is substantially equivalent to legally marketed predicate devices, not a study detailing specific performance acceptance criteria or results.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines extending from its body, representing the department's services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Yasuhuru Ishii Manager, Ultrasound Product ... ... .. . . . . . . . . . . . . . . . . Engineering and Technical Support ............................................................................................................................................ Shimazu Medical Systems 20101 South Vermont Ave. Torrence, CA 90502
Re: K970508 Echo View SDU-2000 Diagnostic Ultrasound System Dated: June 20, 1997 Received: June 23, 1997 Regulatory class: II 21 CFR 892.1550/Procode: 90 IYO
Dear Mr. Yashuhuru:
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 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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the SDU-2000, as described in your premarket notification:
Transducer Model Number 2.5 MHz PA SECTOR 3.5 MHz PA SECTOR 5.0 MHz PA SECTOR 3.5 MHz R40 CA CONVEX 3.5 MHz R76 CA CONVEX 7.5 . MHz LA LINEAR ARRAY 5.5 MHZ TV CONVEX
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 (QS) for Medical Devices: General regulation ( CFR Part 820) and that, through periodic QS inspections, the Food and
{1}------------------------------------------------
Page 2 - Yasuhuru Ishii
Drug Administration (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 Ecderal 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. ----------------------------------------------------------------------------------------------------------
Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.
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 February 17, 1993 "Revised 510(k) Diagnostic Ultrasound Guidance for 1993." 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-fiee number (800) 638-2041 or at (301) 443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html",
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Page 3 - Yasuhuru Ishii\
If you have any questions regarding the content of this letter, please contact Maureen Butler at (301) 594-1212.
Sincerely yours,
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
ﻤﺴ
Enclosure
{3}------------------------------------------------
510(k) Number (if known) : 910(K) Name : Diagnostic Ultrasound System SDU-2000, PA probe 2,5
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) ** | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | X | X | X | |||||||
| Intra-operative(Specify) | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) * | ||||||||||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | X | X | X | X | X | X | X | X | X | |
| CardiacPediatric | X | X | X | X | X | X | X | X | X | |
| Trans-esophageal | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Intra-luminal | ||||||||||
| Trans-utethral | ||||||||||
| Peripheralvessel | ||||||||||
| Laparoscopic |
Mode of Operation
Other Indications or Modes:
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Совситевое of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
Prescription Use (Per 21 CFR 801.109)
510(k) Number K970508
LY
{4}------------------------------------------------
510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-2000, PA probe 3.5
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) ** | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | X | X | X | |||||||
| Intra-operative(Specify) | ||||||||||
| Intra-operative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) * | ||||||||||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | X | X | X | X | X | X | X | X | ||
| CardiacPediatric | X | X | X | X | X | X | X | X | ||
| Trans-esophageal | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Intra-luminal | ||||||||||
| Trans-utethral | ||||||||||
| Peripheralvessel | ||||||||||
| Laparoscopic |
Other Indications or Modes:
** B/M, B/PWD, Color/PWD, B/PWD/M, Color/M and Color/PWD/M mode
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGES IF NEEDED)
Соволитемое оf CDRH, Office of Device Erahsation (ODE)
(Division Sign-Off)
S
Division of Reproductive, Abdominal, ENT and Radiological Device
Prescription Use (Per 21 CFR 801.109)
510(k) Number K970508
{5}------------------------------------------------
Ultrasound Device Indications Statement
Page 3 of _ 7 _ .
510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-2000, PA probe 5.0
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) ** | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | X | X | X | |||||||
| Intra-operative(Specify) | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) * | ||||||||||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | X | X | X | X | X | X | X | X | ||
| CardiacPediatric | X | X | X | X | X | X | X | X | ||
| Trans-esophageal | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Intra-luminal | ||||||||||
| Trans-utethral | ||||||||||
| Peripheralvessel | ||||||||||
| Laparoscopic |
Mode of Operation
Other Indications or Modes:
** B/M, B/PWD, Color/PWD, B/PWD/M, Color/M and Color/PWD/M mode
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEWDED Concerrence of CDRH, Office of Dev on Evaluati (ODE)
510(k) Number
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
Prescription Use (Per 21 CFR 801.109)
{6}------------------------------------------------
Page _ 4_ of __ 7__
Ultrasound Device Indications Statement
510(k) Number (if known) :
5 ro(x) Name : Diagnostic Ultrasound System SDU-2000, CA probe 3.5 R40
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) ** | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | X | X | X | X | X | X | X | |||
| Abdominal | X | X | X | X | X | X | X | X | ||
| Intra-operative(Specify) | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) * | ||||||||||
| NeonatalCephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ||||||||||
| CardiacPediatric | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Intra-luminal | ||||||||||
| Trans-utethral | ||||||||||
| Peripheralvessel | ||||||||||
| Laparoscopic |
Mode of Oneration
Other Indications or Modes:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NELDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Dadiolo
{7}------------------------------------------------
510(k) Number (if known) :
9 rott) Name : Diagnostic Ultrasound System SDU-2000, CA probe 3.5 R76
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)** | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | X | X | X | X | X | X | X | |||
| Abdominal | X | X | X | X | X | X | X | |||
| Intra-operative(Specify) | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) * | ||||||||||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ||||||||||
| CardiacPediatric | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Intra-luminal | ||||||||||
| Trans-urethral | ||||||||||
| Peripheralvessel | ||||||||||
| Laparoscopic |
Mode of Oneration
Other Indications or Modes:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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 K970508
LLY
{8}------------------------------------------------
Page 6 _ of __ .
510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-2000, LA probe 7.5 PV
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) ** | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative(Specify) | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) * | X | X | X | X | X | X | X | X | ||
| NeonatalCephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ||||||||||
| CardiacPediatric | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Intra-luminal | ||||||||||
| Trans-utethral | ||||||||||
| Peripheralvessel | X | X | X | X | X | X | X | X | ||
| Laparoscopic |
Other Indications or Modes:
- Thyroid, Testicles, Breast
** B/M, B/PWD, Color/PWD, B/PWD/M, Color/M and Color/TWD/M mode
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Dev Evel tion (ODE) 0 ব S (Division Sign Off) (Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number _
Prescription Use (Per 21 CFR 801.109)
{9}------------------------------------------------
Page _ 7 _ of _ 7 _ . Ultrasound Device Indications Statement
510(k) Number (if known) : JTo(K) Name : Diagnostic Ultrasound System SDU-2000, TV probe 5.5 11R
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)** | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | X | X | X | X | X | X | X | |||
| Abdominal | ||||||||||
| Intra-operative(Specify) | ||||||||||
| Intra-operative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) * | X | X | X | X | X | X | X | |||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ||||||||||
| CardiacPediatric | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-rectal | X | X | X | X | X | X | X | |||
| Trans-vaginal | X | X | X | X | X | X | X | |||
| Intra-luminal | ||||||||||
| Trans-utethral | ||||||||||
| Peripheralvessel | ||||||||||
| Laparoscopic |
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
Mode of Operation
Other Indications or Modes:
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Othoe of Device E a (DDE) ivision Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev Prescription Use (Per 21 CFR 801.109) 510(k) Number
§ 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.