(94 days)
Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler, Harmonic Imaging and 3D Imaging.
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of transrectal biopsy.
Subscript "f": Includes imaging for guidance of transvaginal biopsy.
Subscript "g": For pediatric patients.
Subscript "h": Includes imaging for guidance of transrectal biopsy.
The Imagin 2011 0000 Diagnoons aging system capable of the following operating pulsed Doppler und palsed continuous Wave Doppler, Color Flow (including Amplitude Doppler). It is also intended for harmonic imaging, superficial musculoskeletal imaging, and 3D imaging.
The Hitachi EUB-8500 Diagnostic Ultrasound Scanner (K013722) received clearance as a general ultrasound imaging system.
The provided document describes the intended uses for the EUB-8500 system with various transducers, indicating where it has "new indications" (marked with "N") for specific clinical applications and modes of operation. However, it does not contain information about acceptance criteria or specific studies proving the device meets those criteria with performance metrics such as accuracy, sensitivity, or specificity.
This document is a 510(k) premarket notification letter from the FDA, which confirms substantial equivalence to legally marketed predicate devices. It focuses on device description, safety (acoustic output and general electrical safety standards), and lists the cleared transducers and their intended uses.
Therefore, I cannot provide the requested information for the following points based on the provided text:
- A table of acceptance criteria and the reported device performance: This is not present in the document. The document lists the intended uses for each transducer, but not performance metrics or acceptance criteria for those uses.
- Sample size used for the test set and the data provenance: No test set details are provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No details on expert-established ground truth for a test set.
- Adjudication method for the test set: No details on adjudication.
- 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: Not applicable, as this is a device clearance for an ultrasound scanner, not an AI-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a device clearance for an ultrasound scanner, not an algorithm.
- The type of ground truth used: Not specified.
- The sample size for the training set: Not specified.
- How the ground truth for the training set was established: Not specified.
Summary of available information from the document:
- Device Description: The Hitachi EUB-8500 Diagnostic Ultrasound Scanner is a diagnostic imaging system capable of pulsed Doppler, continuous Wave Doppler, Color Flow (including Amplitude Doppler), harmonic imaging, superficial musculoskeletal imaging, and 3D imaging.
- Safety:
- As a Track 3 ultrasound device, it includes real-time display of Thermal and Mechanical Acoustic Output Indices, complying with NEMA standards (OD 3) and FDA guidelines (April 14, 1994, Revision of 510(k) Diagnostic Ultrasound Guidance).
- It also complies with general safety standard IEC 60601-1 (1998) Medical Electrical Equipment, Part 1, General Requirements for Safety.
- Intended Use: The document details the intended uses for the EUB-8500 system with various transducers (EUP-B314, EUP-C514, EUP-ES322, EUP-ES52M, EUP-ES533, EUP-F531, EUP-L54M, EUP-L53S, EUP-OL334, EUP-R53W, EUP-S50, EUP-TC3, EUP-U533, EUP-V53W) across different clinical applications and modes of operation (B, M, PWD, CWD, Color Doppler, Combined, and Other (Amplitude Doppler, Harmonic Imaging, 3D Imaging)). "N" indicates a new indication for a specific application/mode combination. Subscripted notes (a-h) provide further clarification on certain clinical applications (e.g., guidance for biopsy).
The substantial equivalence determination is based on the device's adherence to established safety standards and its demonstration of equivalent technology and intended uses to predicate devices. This type of clearance does not typically involve efficacy studies with detailed performance metrics or clinical study data like those requested for deep learning algorithms.
{0}------------------------------------------------
FEB 1 1 2002
SUMMARY OF SAFETY AND EFFECTIVENESS Hitachi EUB-8500 Diagnostic Ultrasound Scanner
Device Description
Device Description The Imagin 2011 0000 Diagnoons aging system capable of the following operating pulsed Doppler und palsed continuous Wave Doppler, Color Flow (including Amplitude Doppler). It is also intended for harmonic imaging, superficial musculoskeletal imaging, and 3D imaging.
Safety
As a Track 3 ultrasound device, the Hitachi EUB-8500 Diagnostic Ultrasound Scanner As a Track J unrasound corros, the al-Time Display of Thermal and Mechanical Acoustic Comput Indices on Diagnostic Ultrasound Equipment (1992)", published by NEMA as Output Indices on Diagnoons Charactic outputs, the Hitachi EUB-8500 Diagnostic OD 3. With respect to millies with the guideline limits set in the April 14, 1994, Revision of 510(k) Diagnostic Ultrasound Guidance.
With regard to general safety, the Hitachi EUB-8500 Diagnostic Ultrasound Scanner is Whill regula to general barby, 60601-1 (1998) Medical Electrical Equipment, Part 1, General Requirements for Safety.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, representing the department's mission of health and well-being. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2002
Mr. Walter Weyburne Regulatory Affairs Hitachi Medical Corporation of America 660 White Plains Road TARRYTOWN NY 10591
Re: K013722
Trade Name: EUB-8500 Diagnostic Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Product Code: 90 IYN Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: 90 IYO Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Product Code: 90 ITX Regulatory Class: II Dated: January 24, 2002 Received: January 25, 2002
Dear Mr. Weyburne:
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 are general ochilers pro 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 EUB-8500 Diagnostic Ultrasound Scanner, as described in your premarket notification:
Transducer Model Number
EUP-B314
{2}------------------------------------------------
| EUP-C514 |
|---|
| EUP-ES322 |
| EUP-ES52M |
| EUP-ES533 |
| EUP-F531 |
| EUP-L54M |
| EUP-L53S |
| EUP-OL334 |
| EUP-R53W |
| EUP-S50 |
| EUP-TC3 |
| EUP-U533 |
| EUP-V53W |
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. may pacifical 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 or mry recent 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 (QS) 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
{3}------------------------------------------------
Page 3 - Mr. Weyburne
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 (301) 594-4591. Additionally, for questions on the contact the Office of Ochipitation at (vice, please contact the Office of Compliance at (301) 594promotion and acroitising or your tion entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the notication (2) Order and the Division of Small Manufacturers, International and Consumer 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 C. Perez at (301) 594-1212.
Sincerely yours,
David C. Slayton
hr
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:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) | ||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging& Other | Fetal | N | N | N | N | N | N | N | ||
| Abdominal | Na | Na | Na | Na | Na | Na | Na | |||
| Intra-operative (Spec.) | Nb | Nb | Nb | Nb | Nb | Nb | ||||
| Intra-operative (Neuro.) | N | N | N | N | N | N | ||||
| Laparoscopic | N | N | N | N | N | N | ||||
| Pediatric | N | N | N | N | N | N | N | |||
| Small Organ (Spec.) | Nd | Nd | Nd | Nd | Nd | Nd | ||||
| Neonatal Cephalic | N | N | N | N | N | N | ||||
| Adult Cephalic | N | N | N | N | N | N | N | |||
| Trans-rectal | Nh | Nh | Nh | Nh | Nh | Nh | ||||
| Trans-vaginal | Nf | Nf | Nf | Nf | Nf | Nf | ||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skel. (Convent.) | N | N | N | N | N | N | ||||
| Musculo-skel. (Superfic.) | N | N | N | N | N | N | ||||
| Intra-luminal | ||||||||||
| Other (spec.) | ||||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N | ||
| Cardiac Pediatric | N | N | N | N | N | N | N | |||
| Trans-esophageal (card.) | Ng | Ng | Ng | Ng | Ng | Ng | ||||
| Other (spec.) | ||||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | N | N | N | ||
| Other (spec.) |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler, Harmonic Imaging and 3D Imaging.
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures(including amniocentesis). |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery |
| (excluding neurosurgery and laparoscopic procedures). | |
| Subscript "b": | Includes imaging of organs and structures exposed during surgery |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Seymore
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K013239
{5}------------------------------------------------
System: EUB-8500 EUP-B314 Transducer:
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | N | N | N | N | N | ||
| Abdominal | Na | Na | Na | Na | Na | Na | ||
| Intra-operative (Spec.) | Nb | Nb | Nb | Nb | Nb | Nb | ||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging& Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler and 3D Imaging.
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures Subscript "a": (including amniocentesis). Includes imaging of organs and structures exposed during surgery Subscript "b": (excluding neurosurgery and laparoscopic procedures). Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. Subscript "d":
Includes imaging for guidance of transrectal biopsy. Subscript "e":
Includes imaging for guidance of transvaginal biopsy. Subscript "f":
For pediatric patients. Subscript "g":
Includes imaging for guidance of transrectal biopsy. Subscript "h":
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
K
David G. Norman
(Division Sign-off)
Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number: K113223
{6}------------------------------------------------
| System: | EUB-8500 |
|---|---|
| Transducer: | EUP-C514 |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | N | N | N | N | N | ||
| Abdominal | Na | Na | Na | Na | Na | Na | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | ||
| Small Organ (Spec.) | Nd | Nd | Nd | Nd | Nd | Nd | ||
| Fetal Imaging& Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler, Harmonic Imaging and 3D Imaging.
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures Subscript "a": (including amniocentesis).
| Subscript "b": | Includes imaging of organs and structures exposed during surgery(excluding neurosurgery and laparoscopic procedures). |
|---|---|
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Nyberg
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K013722
{7}------------------------------------------------
System: Transducer:
EUB-8500 BUP-ES322
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging& Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Spec.) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Spec.) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (card.) | N | N | N | N | N | N | |||
| Other (spec.) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (spec.) |
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler and 3D Imaging.
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures Subscript "a": (including am nincente sis)
| Subscript "b": | Includes imaging of organs and structures exposed during surgery(excluding neurosurgery and laparoscopic procedures). |
|---|---|
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS MN. CONNING ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Severson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K101329
{8}------------------------------------------------
System: EUB-8500 Transducer:
EUP-ES52M
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Spec.) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Spec.) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging& Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (card.) | N | N | N | N | N | N | N | ||
| Other (spec.) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (spec.) |
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler and 3D Imaging.
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures Subscript "a": lincluding am 13 oial
| Subscript "b": | Includes imaging of organs and structures exposed during surgery(excluding neurosurgery and laparoscopic procedures). |
|---|---|
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS CINE CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Symon
(Division Sign-Off Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K014553
{9}------------------------------------------------
| System: | |
|---|---|
| Transducer: |
EUB-8500 EUP-ES533
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging& Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | Ng | Ng | Ng | Ng | Ng | Ng | ||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler and 3D Imaging.
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures Subscript "a": (including amniocentesis).
| Subscript "b": | Includes imaging of organs and structures exposed during surgery(excluding neurosurgery and laparoscopic procedures). |
|---|---|
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
Tip #1: Includes language for guidance or contextual clarity.
(PLEASE DO NOT WRITE BELOW THIS DINECONVINCE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Javid A. Begson
(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Devices
510(k) Number: K050934
{10}------------------------------------------------
| System: | EUB-8500 |
|---|---|
| Transducer: | EUP-F531 |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| (Track I only) | (Tracks I & III) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | ||
| Intra-operative (Spec.) | Nb | Nb | Nb | Nb | Nb | Nb | ||
| Intra-operative (Neuro.) | N | N | N | N | N | N | ||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | ||
| Small Organ (Spec.) | Nc | Nc | Nc | Nc | Nc | Nc | ||
| Neonatal Cephalic | N | N | N | N | N | N | ||
| Fetal Imaging | Adult Cephalic | |||||||
| & Other | Trans-rectal | N | N | N | N | N | N | |
| Trans-vaginal | N | N | N | N | N | N | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | N | |
| Vessel | Other (spec.) |
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler and 3D Imaging.
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures Subscript "a": (including amniocentesis). Includes imaging of organs and structures exposed during surgery Subscript "b": (excluding neurosurgery and laparoscopic procedures).
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
|---|---|
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Nyberg
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number: KC103723
{11}------------------------------------------------
System: Transducer:
EUB-8500 EUP-L54M
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other **(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | Na | Na | Na | Na | Na | Na | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | N | N | N | N | N | N | ||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | ||
| Small Organ (Spec.) | Nd | Nd | Nd | Nd | Nd | Nd | ||
| Neonatal Cephalic | ||||||||
| Fetal Imaging& Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | N | N | ||
| Musculo-skel. (Superfic.) | N | N | N | N | N | N | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | N | N | |
| Other (spec.) |
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler and 3D Imaging.
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures Subscript "a": (including amniocentesis).
| Subscript "b": | Includes imaging of organs and structures exposed during surgery |
|---|---|
| (excluding neurosurgery and laparoscopic procedures). | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BE CONTINUE ON ANOTHER PAGE IF NEEDED)
Varish A. Seymm
(Division Sign-Off, Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K061222
{12}------------------------------------------------
| System: | |
|---|---|
| Transducer: |
EUB-8500 EUP-L53S
| "-tended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows. | |||
|---|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Comments of the consisted on the consisted on the consisted on the controlled of the contribution of the firstCompany of Children Company of Children Company of Children Comments of Children | THE VIEW THE LEAST CO-ACCLASS |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | Na | Na | Na | Na | Na | Na | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | N | N | N | N | N | N | ||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | ||
| Small Organ (Spec.) | Nd | Nd | Nd | Nd | Nd | Nd | ||
| Neonatal Cephalic | ||||||||
| Fetal Imaging& Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | N | N | ||
| Musculo-skel. (Superfic.) | N | N | N | N | N | N | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | N | N | |
| Other (spec.) |
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler and 3D Imaging.
Additional Comments:
Additional Comments.
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "h". ns and structures exposed during surgery maging of orga 1.5.7.1.5
| Subscript "b": | Includes imaging of organs and structures exposed during surgery(excluding neurosurgery and laparoscopic procedures). |
|---|---|
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEBDED)
Emrich A. Seymore
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K973122
{13}------------------------------------------------
System: Transducer:
EUB-8500 EUP-OL334
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: Mode of Operation
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | N | N | N | N | N | N | ||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging& Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler and 3D Imaging.
Additional Comments:
Subscript "A". Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures 8.99 14.9
| (including amniocentesis). | |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery(excluding neurosurgery and laparoscopic procedures). |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Bynam
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: `K043522
{14}------------------------------------------------
| System: | |
|---|---|
| Transducer: |
EUB-8500 EUP-R53W
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging& Other | Adult Cephalic | |||||||
| Trans-rectal | N | N | N | N | N | N | ||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler and 3D Imaging.
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures Subscript "a": (including amniocentesis).
| Subscript "b": | Includes imaging of organs and structures exposed during surgery(excluding neurosurgery and laparoscopic procedures). |
|---|---|
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Daniel A. Sgroi
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K013712
{15}------------------------------------------------
System: Transducer:
EUB-8500 BOP-S50
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other **(Spec.) | |
| Ophthalmic | Ophthalmic | N | N | N | N | N | N | N | |
| Fetal | N | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | N | ||
| Intra-operative (Spec.) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | ||
| Small Organ (Spec.) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | Adult Cephalic | N | N | N | N | N | N | N | |
| & Other | Trans-rectal | ||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N | |
| Cardiac Pediatric | N | N | N | N | N | N | N | ||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | N | N | |
| Vessel | Other (spec.) |
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler, Harmonic Imaging and 3D Imaging.
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures Subscript "a": 15.732
| (including amniocentesis). | |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery(excluding neurosurgery and laparoscopic procedures). |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS DINE CONVINUE ON ANOTHER PAGE IF NEEDED)
David A. Seymore
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K101372
{16}------------------------------------------------
System: Transducer:
EUB-8500 EUP-TC3
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging& Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | N | ||||||
| Cardiac Pediatric | N | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | N | ||||||
| Other (spec.) |
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler. **Amplitude Doppler.
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures(including amniocentesis). |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery(excluding neurosurgery and laparoscopic procedures). |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS BIN CONNULON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Varril A. deason
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Deviçes
510(k) Number: K103223
{17}------------------------------------------------
System: EUB-8500 Transducer: EUP-U533
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging& Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Spec.) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Spec.) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | Nh | Nh | Nh | Nh | Nh | Nh | Nh | ||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (spec.) |
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler and 3D Imaging.
Additional Comments:
Subscript "a". Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
| Subscript "b": | Includes imaging of organs and structures exposed during surgery(excluding neurosurgery and laparoscopic procedures). |
|---|---|
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Dyson
Division Sign Off
(Division Sign-Off Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K032272
{18}------------------------------------------------
System: Transducer: EUB-8500
EUP-V53W
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | |||
| Abdominal | |||||||||
| Intra-operative (Spec.) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Spec.) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | Adult Cephalic | ||||||||
| & Other | Trans-rectal | Ne | Ne | Ne | Ne | Ne | Ne | ||
| Trans-vaginal | Nf | Nf | Nf | Nf | Nf | Nf | |||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (spec.) |
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler and 3D Imaging.
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures
| (including amniocentesis). | |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery(excluding neurosurgery and laparoscopic procedures). |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
script 1. Increase imaging for guidance of treatment biopsy.
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Thrist G. Inam
(Division Sign-Gif) Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number: K013621
§ 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.