(124 days)
Not Found
Not Found
No
The document does not mention AI, ML, or any related terms in the device description or other sections. The description focuses on standard ultrasound imaging modes.
No.
The device description clearly states it is a "Diagnostic ultrasound imaging or fluid flow analysis" system, indicating its purpose is for diagnosis rather than therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis if the human body". Furthermore, the "Device Description" section names the device as the "Hitachi EUB-6000 Ultrasound Diagnostic Scanner".
No
The device description explicitly states it is a "Diagnostic Ultrasound Scanner" and describes various operating modes (B, M, Doppler, Color Flow), indicating it is a hardware-based imaging system, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this ultrasound system is for imaging the human body directly. It's a non-invasive imaging modality.
- The description focuses on imaging and fluid flow analysis within the body. There is no mention of analyzing blood, urine, tissue samples, or any other biological specimens that would be tested in vitro (outside the body).
Therefore, the Hitachi EUB-6000 Ultrasound Diagnostic Scanner is a diagnostic imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The Hitachi EUB-6000 Ultrasound Diagnostic Scanner is a Track 3 diagnostic ultrasound pulsed Doppler and pulsed echo imaging system capable of the following operating modes: B (including harmonic imaging), M, Pulsed and Continuous Doppler, and Color Flow (including Amplitude Doppler). It is intended for general ultrasound imaging of the human body, with specific uses under the general applications of cardiac, peripheral vessel, and fetal imaging and other.
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM EUB-6000
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
For System:
Clinical Application: General (Track I only)
Specific (Tracks I & III): Ophthalmic, 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 Adult, Cardiac Pediatric, Trans-esophageal (card.), Other (spec.), Peripheral vessel, Other (spec.).
Mode of Operation where N is marked indicating new indication:
B, M, PWD, CWD, Color Doppler, Combined* (Spec.), Other** (Spec.) are all indicated for: Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro.), Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel.
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.
** Amplitude Doppler and Harmonic 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, and 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": Includes pediatric patients.
Subscript "h": Includes imaging for guidance of transrectal biopsy.
For Transducer EUP-B314:
Clinical Application: General (Track I only)
Specific (Tracks I & III): Fetal, Abdominal, Intra-operative (Spec.)
Mode of Operation where N is marked indicating new indication:
B, M, PWD, Color Doppler, Combined* (Spec.), Other** (Spec.) are all indicated for: Fetal, Abdominal, Intra-operative (Spec.)
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.
** Amplitude Doppler and Harmonic Imaging.
Additional Comments a, b.
For Transducer EUP-C314G:
Clinical Application: General (Track I only)
Specific (Tracks I & III): Fetal, Abdominal, Pediatric, Small Organ (Spec.)
Mode of Operation where N is marked indicating new indication:
B, M, PWD, Color Doppler, Combined* (Spec.), Other** (Spec.) are all indicated for: Fetal, Abdominal, Pediatric, Small Organ (Spec.)
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.
** Amplitude Doppler and Harmonic Imaging.
Additional Comments a, b, c, d.
For Transducer EUP-ES322:
Clinical Application: Cardiac
Specific (Tracks I & III): Trans-esophageal (card.)
Mode of Operation where N is marked indicating new indication:
B, M, PWD, Color Doppler, Combined* (Spec.), Other** (Spec.) are all indicated for: Trans-esophageal (card.)
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.
** Amplitude Doppler and Harmonic Imaging.
Additional Comments g.
For Transducer EUP-ES52M:
Clinical Application: Cardiac
Specific (Tracks I & III): Trans-esophageal (card.)
Mode of Operation where N is marked indicating new indication:
B, M, PWD, CWD, Color Doppler, Combined* (Spec.), Other** (Spec.) are all indicated for: Trans-esophageal (card.)
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.
** Amplitude Doppler and Harmonic Imaging.
Additional Comments g.
For Transducer EUP-ES533:
Clinical Application: Cardiac
Specific (Tracks I & III): Trans-esophageal (card.)
Mode of Operation where Ng is marked indicating new indication with pediatric patients:
B, M, PWD, CWD, Color Doppler, Combined* (Spec.), Other** (Spec.) are all indicated for: Trans-esophageal (card.) with pediatric patients.
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.
** Amplitude Doppler and Harmonic Imaging.
For Transducer EUP-F531:
Clinical Application: General (Track I only), Fetal Imaging & Other, Peripheral Vessel
Specific (Tracks I & III): Abdominal, Intra-operative (Spec.), Intra-operative (Neuro.), Pediatric, Small Organ (Spec.), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Peripheral vessel.
Mode of Operation where N is marked indicating new indication:
B, M, PWD, Color Doppler, Combined* (Spec.), Other** (Spec.) are all indicated for: Abdominal, Intra-operative (Spec.), Intra-operative (Neuro.), Pediatric, Neonatal Cephalic, Trans-rectal, Trans-vaginal, Peripheral vessel.
Additionally, Nc is indicated for Small Organ (Spec.): B, M, PWD, Color Doppler, Combined* (Spec.), Other** (Spec.).
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.
** Amplitude Doppler and Harmonic Imaging.
Additional Comments b, c, e, f.
For Transducer EUP-L34T:
Clinical Application: General (Track I only), Fetal Imaging & Other, Peripheral Vessel
Specific (Tracks I & III): Abdominal, Intra-operative (Neuro.), Pediatric, Small Organ (Spec.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Peripheral vessel.
Mode of Operation where N is marked indicating new indication:
B, M, PWD, Color Doppler, Combined* (Spec.), Other** (Spec.) are all indicated for: Intra-operative (Neuro.), Pediatric, Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Peripheral vessel.
Additionally, Na is indicated for Abdominal: B, M, PWD, Color Doppler, Combined* (Spec.), Other** (Spec.).
Additionally, Nd is indicated for Small Organ (Spec.): B, M, PWD, Color Doppler, Combined* (Spec.), Other** (Spec.).
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.
** Amplitude Doppler and Harmonic Imaging.
Additional Comments a, b, d.
For Transducer EUP-L53S:
Clinical Application: General (Track I only), Fetal Imaging & Other, Peripheral Vessel
Specific (Tracks I & III): Abdominal, Intra-operative (Neuro.), Pediatric, Small Organ (Spec.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Peripheral vessel.
Mode of Operation where N is marked indicating new indication:
B, M, PWD, Color Doppler, Combined* (Spec.), Other** (Spec.) are all indicated for: Intra-operative (Neuro.), Pediatric, Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Peripheral vessel.
Additionally, Na is indicated for Abdominal: B, M, PWD, Color Doppler, Combined* (Spec.), Other** (Spec.).
Additionally, Nd is indicated for Small Organ (Spec.): B, M, PWD, Color Doppler, Combined* (Spec.), Other** (Spec.).
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.
** Amplitude Doppler and Harmonic Imaging.
Additional Comments a, b, d.
For Transducer EUP-OL334:
Clinical Application: Fetal Imaging & Other
Specific (Tracks I & III): Laparoscopic
Mode of Operation where N is marked indicating new indication:
B, M, PWD, Color Doppler, Combined* (Spec.), Other** (Spec.) are all indicated for: Laparoscopic.
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.
** Amplitude Doppler and Harmonic Imaging.
For Transducer EUP-R53W:
Clinical Application: Fetal Imaging & Other
Specific (Tracks I & III): Trans-rectal
Mode of Operation where N is marked indicating new indication:
B, M, PWD, Color Doppler, Combined* (Spec.), Other** (Spec.) are all indicated for: Trans-rectal.
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.
** Amplitude Doppler and Harmonic Imaging.
Additional Comments h.
For Transducer EUP-S31T:
Clinical Application: Fetal Imaging & Other, Cardiac, Peripheral Vessel
Specific (Tracks I & III): Fetal, Abdominal, Pediatric, Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
Mode of Operation where N is marked indicating new indication:
B, M, PWD, CWD, Color Doppler, Combined* (Spec.), Other** (Spec.) are all indicated for: Fetal, Abdominal, Pediatric, Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.
** Amplitude Doppler and Harmonic Imaging.
For Transducer EUP-TC3:
Clinical Application: Cardiac
Specific (Tracks I & III): Cardiac Adult, Cardiac Pediatric
Mode of Operation where N is marked indicating new indication:
CWD is indicated for: Cardiac Adult, Cardiac Pediatric.
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.
** Amplitude Doppler and Harmonic Imaging.
For Transducer EUP-U533:
Clinical Application: Fetal Imaging & Other
Specific (Tracks I & III): Trans-rectal
Mode of Operation where Nh is marked indicating new indication with imaging for guidance of transrectal biopsy:
B, M, PWD, Color Doppler, Combined* (Spec.), Other** (Spec.) are all indicated for: Trans-rectal with imaging for guidance of transrectal biopsy.
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.
** Amplitude Doppler and Harmonic Imaging.
For Transducer EUP-V53W:
Clinical Application: Fetal Imaging & Other
Specific (Tracks I & III): Fetal, Trans-rectal, Trans-vaginal
Mode of Operation where N is marked indicating new indication:
B, M, PWD, Color Doppler, Combined* (Spec.), Other** (Spec.) are indicated for: Fetal.
Additionally, Ne is indicated for Trans-rectal: B, M, PWD, Color Doppler, Combined* (Spec.), Other** (Spec.).
Additionally, Nf is indicated for Trans-vaginal: B, M, PWD, Color Doppler, Combined* (Spec.), Other** (Spec.).
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.
** Amplitude Doppler and Harmonic Imaging.
Additional Comments e, f.
Product codes (comma separated list FDA assigned to the subject device)
90 IYN, 90 IYO
Device Description
The Hitachi EUB-6000 Ultrasound Diagnostic Scanner is a Track 3 diagnostic ultrasound pulsed Doppler and pulsed echo imaging system capable of the following operating modes: B (including harmonic imaging), M, Pulsed and Continuous Doppler, and Color Flow (including Amplitude Doppler). It is intended for general ultrasound imaging of the human body, with specific uses under the general applications of cardiac, peripheral vessel, and fetal imaging and other.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Human body, cardiac, peripheral vessel, fetal, ophthalmic, abdominal, intra-operative, neurosurgery, laparoscopic, pediatric, small organ, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, trans-urethral, trans-esophageal, musculoskeletal (conventional), musculoskeletal (superficial), intra-luminal, thyroid, parathyroid, breast, scrotum, penis.
Indicated Patient Age Range
Not Found. However, includes pediatric, neonatal, and adult patients.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Hitachi EUB-6000 Ultrasound Diagnostic Scanner K994026
MAR 2 9 2000
SUMMARY OF SAFETY AND EFFECTIVENESS Hitachi EUB-6000 Ultrasound Diagnostic Scanner
Device Description
The Hitachi EUB-6000 Ultrasound Diagnostic Scanner is a Track 3 diagnostic ultrasound pulsed Doppler and pulsed echo imaging system capable of the following operating modes: B (including harmonic imaging), M, Pulsed and Continuous Doppler, and Color Flow (including Amplitude Doppler). It is intended for general ultrasound imaging of the human body, with specific uses under the general applications of cardiac, peripheral vessel, and fetal imaging and other.
Safety
As a Track 3 ultrasound device, the Hitachi EUB-6000 Ultrasound Diagnostic Scanner complies with the "Standard for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (1992)", published by the National Electrical Manufacturers Association as UD-3. With respect to limits on acoustic outputs, the Hitachi EUB-6000 Ultrasound Diagnostic Scanner complies 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-6000 Ultrasound Diagnostic Scanner is designed to comply with IEC 601-1 (1988) Medical Electrical Equipment, Part 1, General Requirements for Safety.
Section 4.2 Page 4
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2000
Charles F. Hottinger, Ph.D. Director, Regulatory Affairs Hitachi Medical Corporation of America Hitachi Medical Systems 660 White Plains Road Tarrytown, NY 10591-5107
K994026 Re: Hitachi EUB-6000 Ultrasound Diagnostic Device Regulatory Class: II Product Code: 90 IYN/21 CFR 892.1550 and 90 IYO/21 CFR 892.1560 Dated: February 25, 2000 Received: February 29, 2000
Dear Dr. Hottinger:
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 Hitachi EUB-6000 Ultrasound Diagnostic Device, as described in your premarket notification:
Transducer Model Numbers
EUP-B314. EUP-C314G. EUP-ES322. EUP-ES52M EUP-ES533, EUP-F531, EUP-L34T, EUP-L53S, EUP-OL334 EUP-R53W, EUP-S31T, EUP-TC3, EUP-U533 and EUP-V53W
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 (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.
2
Page 2 -Charles F. Hottinger, Ph.D.
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 C. Perez at (301) 594-1212.
Sincerely yours,
Daniel A. Lyon
by Daniel C. Schultz, M.D.
aniel G Schultz Captain, USPHS Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
3
System:
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM EUB-6000
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: | ||
|---|---|---|
| A - Station Comments of Children Market All - A A B - A B - A B - A B - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Comments of the many of the more of the All All All All All A di A A divis A di A A di A A di A A di A A di A A di A A di A A di A A di A A di A A di A A di A A di A A di A A |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| 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 | ||
| Fetal Imaging | ||||||||
| & Other | 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 Adult | N | N | N | N | N | N | N | |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | N | N |
| Trans-esophageal (card.) | Ng | Ng | Ng | Ng | Ng | Ng | ||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | 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 Harmonic 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, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy Subscript "d":
Subscript "e": Includes imaging for guidance of transrectal biopsy.
Includes imaging for guidance of transvaginal biopsy. Subscript "f":
Subscript "g": Includes 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)
David A. Sezman
Division of Reprodu and Radiological D
510(k) Number: K994026
4
System: Transducer
EUB-6000
EUP-B314
| 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 | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | 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 | ||||||||
| 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.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication.
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler
** Amplitude Doppler and Harmonic 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, and 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": Includes pediatric patients.
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)
David C. Syzman
Sion Division of Reproductive, Abe dominal. P and Radiologic
510(k) Number: K944026
5
System: Transducer
EUB-6000 EUP-C314G
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 | Color | |||
| Doppler | 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.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | N | N | ||
| Small Organ (Spec.) | Nd | Nd | Nd | Nd | Nd | Nd | ||
| 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 Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication.
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler
** Amplitude Doppler and Harmonic 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, and 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": Includes 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)
David A. Seaymon
Division of Reproductive, Abdomin
510(k) Numbe
6
System: Transducer
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
EUB-6000 EUP-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 | Color | ||||
| Doppler | Combined* | ||||||||
| (Spec.) | Other** | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Spec.) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging | |||||||||
| & Other | 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 Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | N | N | N | N | N | N | |||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) |
N= new indication.
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.
** Amplitude Doppler and Harmonic Imaging
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (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, and penis. Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy Subscript "d":
Subscript "e": Includes imaging for guidance of transrectal biopsy.
Subscript "f": Includes imaging for guidance of transvaginal biopsy.
Subscript "g": Includes 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)
David A. Leggett
(Division Sign-Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number: K994026
7
System: Transducer
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM EUB-6000
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 | Color | |||
| Doppler | 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 Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | N | N | N | N | N | N | N | |
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication.
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.
** Amplitude Doppler and Harmonic Imaging
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (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, and 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":
Includes 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 h. Se yman
Division Sion-6 Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number: K944026
8
System:
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
EUB-6000 Transducer 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 | Color | ||||
| Doppler | Combined* | ||||||||
| (Spec.) | Other** | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Spec.) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging | Laparoscopic | ||||||||
| & Other | 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 Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | Ng | Ng | Ng | Ng | Ng | Ng | Ng | ||
| 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 Harmonic Imaging
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including Subscript "a": amniocentesis).
Includes imaging of organs and structures exposed during surgery Subscript "b":
(excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and 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": Includes 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. Heyman
Division Sign-Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number:
Prescription Use (Per 21 CFR 801.109)
9
EUB-6000
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System: Transducer
EUP-F531
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 | Color | ||||
| Doppler | Combined* | ||||||||
| (Spec.) | Other** | ||||||||
| (Spec.) | |||||||||
| 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 | |||
| Fetal Imaging | |||||||||
| & Other | 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 | |||
| Adult Cephalic | |||||||||
| 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 | |||||||||
| Vessel | 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 Harmonic 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, and 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": Includes 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)
David A. Segmen
(Division Sign-C Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number
Prescription Use (Per 21 CFR 801.109)
10
System:
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
EUB-6000 EUP-L34T
Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| General | ||||||||
| (Track I only) | Ophthalmic | |||||||
| Ophthalmic | Fetal | |||||||
| Abdominal | Na | Na | Na | Na | Na | Na | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | N | N | N | N | N | N | ||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | N | N | ||
| Small Organ (Spec.) | Nd | Nd | Nd | Nd | Nd | Nd | ||
| Neonatal Cephalic | ||||||||
| 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 Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | 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 Harmonic Imaging
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including Subscript "a": amniocentesis).
Includes imaging of organs and structures exposed during surgery Subscript "b":
(excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy
Subscript "e": Includes imaging for guidance of transrectal biopsy. Includes imaging for guidance of transvaginal biopsy.
Subscript "f":
Subscript "g": Includes 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)
David A. Segerson
Division Sign Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K944026
11
System: Transducer EUB-6000 EUP-L53S
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 | Color | |||
| Doppler | 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 | ||
| Fetal Imaging | Laparoscopic | |||||||
| & Other | Pediatric | N | N | N | N | N | N | |
| Small Organ (Spec.) | Nd | Nd | Nd | Nd | Nd | Nd | ||
| Neonatal Cephalic | ||||||||
| 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 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 Harmonic 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, and 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": Includes 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)
David a. Seymour
Division of Reproductive, Abdominal, ENT and Radiological D
510(k) Number: K994026
12
EUP-OL334
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM EUB-6000
System: 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 | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | N | N | N | N | N | N | ||
| 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.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication.
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler
** Amplitude Doppler and Harmonic 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, and 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": Includes 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. Leyson
Division of Reproductive, Abdominal, El and Radiological
510(k) Number: K944024
13
EUP-R53W
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM EUB-6000
System: Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| General
| (Track I only) | Clinical Application | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | 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 | 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 | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication.
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.
** Amplitude Doppler and Harmonic 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, and penis.
- Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy Subscript "d":
Subscript "e": Includes imaging for guidance of transrectal biopsy.
- Subscript "f": Includes imaging for guidance of transvaginal biopsy.
- Subscript "g": Includes 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)
David C. Styron
Division Sign-Division of Reproductive, Abdominal, EL and Radiological D 510(k) Number:
14
System: Transducer
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
EUB-6000 EUP-S31T
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 | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | N | N | N | N | N | N | |
| Abdominal | N | N | N | N | N | N | N | |
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | N | N | N | |
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | N | N | N | N | N | N | N | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | N | N | N | N | N | N | N | |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | N | N |
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | 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 Harmonic Imaging
Additional Comments: તે
| 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, and 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": Includes 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)
David A. Lyons
(Division Sign-Division of Reproductive, Abdominal, EN and Radiological Device
510(k) Number:
15
System: Transducer DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM EUB-6000
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 | Color | |||
| Doppler | 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 Adult | N | |||||||
| Cardiac | Cardiac Pediatric | N | ||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | ||||||
| Other (spec.) |
N= new indication.
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.
** Amplitude Doppler and Harmonic 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. |
Subscript "b" Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and 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": Includes 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)
David A. Seaman
(Division Sign-Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Numbe
Prescription Use (Per 21 CFR 801.109)
16
System: Transducer
EUB-6000
EUP-U533
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: | |
|---|---|
| and and the company of a many of the first and any of the champion of the country of |
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | 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.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication.
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.
** Amplitude Doppler and Harmonic 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).
Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "c":
Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy Subscript "d":
Subscript "e": Includes imaging for guidance of transrectal biopsy.
Subscript "f": Includes imaging for guidance of transvaginal biopsy
Includes pediatric patients. Subscript "g":
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)
David A. Segmen
Division of Re anı
510(k) Numb
Prescription Use (Per 21 CFR 801.109)
17
System:
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
EUB-6000 EUP-V53W
Transducer
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: | |||
|---|---|---|---|
| . | Comments of the control of the control of the control controllation of the comments of the comments of the comments of |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | N | N | N | N | N | ||
| Abdominal | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| 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 | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication.
*Combination of each operating mode: B, M. PWD, CWD, and Color Doppler.
** Amplitude Doppler and Harmonic 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, and 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": Includes pediatric patients.
Subscript "h": Includes imaging for guidance of transrectal biopsy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANQTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David C. Leggmm
(Division Sigff-Off)
Division of Reproductive, Abdominal, ENT and Radiologic
510(k) Numbe