(17 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, nor does it describe any features or performance metrics typically associated with AI/ML-powered devices.
No
The device is described as a "Diagnostic Ultrasound Scanner" used for "Diagnostic ultrasound imaging or fluid flow analysis," indicating its primary function is to identify or characterize conditions, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis", and the "Device Description" identifies it as "EUB-6500 Diagnostic Ultrasound Scanner".
No
The device description explicitly states "EUB-6500 Diagnostic Ultrasound Scanner," which is a hardware device. The input imaging modality also describes a hardware system (Ultrasonic Pulsed Echo and Pulsed Doppler Imaging System; Diagnostic Ultrasound Transducer).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Diagnostic ultrasound imaging or fluid flow analysis if the human body". This describes a device that interacts directly with the patient's body to produce images or analyze flow within the body.
- Device Description: It's described as a "Diagnostic Ultrasound Scanner". Ultrasound scanners are used for in-vivo imaging.
- Input Imaging Modality: The input is "Ultrasonic Pulsed Echo and Pulsed Doppler Imaging System; Diagnostic Ultrasound Transducer". These are components of an in-vivo ultrasound system.
- Anatomical Site: The list of anatomical sites are all locations within the human body.
IVD devices are designed to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device does not fit that description.
N/A
Intended Use / Indications for Use
Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-ITX, IYN, IYO, ITX
Device Description
EUB-6500 Diagnostic Ultrasound Scanner
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Ophthalmic, Fetal, Abdominal, Intra-operative (Specific), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Specific), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Intra-luminal, Cardiac Adult, Cardiac Pediatric, Trans esophageal (card.), Peripheral vessel.
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Includes thyroid, parathyroid, breast, scrotum, penis.
Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Includes imaging for guidance of transrectal biopsy.
Includes imaging for guidance of transvaginal biopsy.
For pediatric patients.
Includes imaging for guidance of transrectal biopsy.
Indicated Patient Age Range
Not Found
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.
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).
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 measurements based on production line devices, requested information, regarding acoustic output values referenced in the Center’s September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Ultrasound Systems and Transducers." If the special report indicates 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".
§ 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
| 05325 | ||
|---|---|---|
| DEC 9 | 2005 | HITACHI |
| Basic Information | ||
| and the contraction and the contribution of the consistent would be considered to the consideration of the contribution of the comments of the |
જ
| 4.2.1 | Manufacturers Name (Ultrasound Scanner): | Hitachi Medical Corporation | |
|---|---|---|---|
| Address: | Hitachi Kamakurabashi Bldg., 1-1-14 | ||
| Uchi-kanda, Chiyoda-ku | |||
| Tokyo 101-0047 Japan | |||
| Corresponding Official: | Doug Thistlethwaite | ||
| Manager, Regulatory Affairs | |||
| Address: | Hitachi Medical Systems America, Inc. | ||
| 1959 Summit Commerce Park | |||
| Twinsburg, Ohio 44087 | |||
| Telephone: | (330) 425-1313 | ||
| 4.2.2 | Initial Distributor (Ultrasound Scanner) : | Hitachi Medical Systems America, Inc. | |
| Address: | 1959 Summit Commerce Park | ||
| Twinsburg, Ohio 44087 | |||
| Telephone: | (330) 425-1313 | ||
| 4.2.3 | Device Name: | EUB-6500 Diagnostic Ultrasound Scanner | |
| 4.2.4 | Common Name: | Diagnostic Ultrasound Unit | |
| 4.2.5 | Classification | ||
| Regulatory Class: | Class II | ||
| Review Category: | Tier II | ||
| FR Number | Product Code | ||
| Ultrasonic Pulsed Echo and Pulsed Doppler | |||
| Imaging System | 892.1550 | 90-IYN | |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX | |
| 4.2.6 | Establishment Registration Number: | Hitachi Medical Corp. (Japan) 8030405 | |
| Hitachi Medical Systems America, Inc. (USA) 1528028 | |||
| 4.2.7 | 514 Performance Standards: | None | |
| 4.2.8 | Special Controls: | Special Report - to be filed at a later date | |
| 4.2.9 | Prescription Status: | Prescription Device | |
| 4.2.10 | Manufacturing Location (Ultrasound | ||
| Scanner): | Hitachi Medical Corporation - Kashiwa Works | ||
| 2-1 Shintoyofuta | |||
| Kashiwa-shi, Chiba-ken | |||
| 277-0804 | |||
| Japan | |||
| 4.2.11 | Sterilization Site(s): | N/A Device is not shipped as sterile. | |
| 4.2.12 | Reason for Submission: | Modification to existing product |
HITACHI Medical Systems America, Inc. © 2005 All Rights Reserved "
.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle emblem.
DEC 9 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hitachi Medical Corporation % Mr. Doug Thistlewaite Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087
Re: K053258
Trade Name: EUB-6500 Diagnostic Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Number: 21 CFR 892.1570 Regulatory Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: November 14, 2005 Received: November 22, 2005
Dear Mr. Thistlewaite:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection or exisi petities is substantially equivalent (for the referenced above and we have acterimine) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate connicted pror to thay 20, 1978, et assified in accordance with the provisions of the Amendinents, or to devices market Act (Act). You may, therefore, market the device, subject to rederal rood, Drug, and Cosment Prec (1. The general controls provisions of the Act include the general controls provisions of the isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for Tills delethination of Substantal equiltrasound Scanner, as described in your premarket notification:
Transducer Model Number
EUP-B514 EUP-C312T
| EUP-C314G |
|---|
| EUP-C511 |
2
| EUP-C516 | EUP-L65 |
|---|---|
| EUP-C524 | EUP-O53T |
| EUP-C532 | EUP-R54A-19 |
| EUP-CC531 | EUP-R54A-33 |
| EUP-CV524 | EUP-R54AW-19 |
| EUP-F334 | EUP-R54AW-33 |
| EUP-L34T | EUP-S50 |
| EUP-L52 | EUP-S50A |
| EUP-L53 | EUP-S52 |
| EUP-L53L | Fujinon SP711 |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (600 aco'v) arols. Existing major regulations affecting your device of the subject to it may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oous of I veceras concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Freast of advised that I Drivedants over device complies with other requirements of the Act that IDA has made a determination administered by other Federal agencies. You must of any I cuchar statutes and regulations and united to: registration and listing (21 Comply with an the 11et 3 requirements, 01); good manufacturing practice requirements as set Cr K Fall 807), labeling (21 CFR Part 820); and if applicable, the electronic a form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping I the first device, you submit a postclearance special report. This report should contain complete the first device, you submit a postered anes arements based on production line devices, requested information, merading accused of the Center's September 30, 1997 "Information for Manufacturers In Appendix U, (cherosou) of the Senter to Clicksound Systems and Transducers." If the special Secking Marketing Orearans 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 This letter will anow you vot substantial equivalence of your device to a legally marketed nonfloation. The I Drivin a classification for your device and thus permits your device to proceed to market.
3
Page 2 - Mr. Thistlethwaite
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours.
Nancy C brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
4
| 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 | P | P | P | P | P | P | P | |||
| Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa | |||
| Intra-operative (Spec.) | Pb | Pb | Pb | Pb | Pb | Pb | ||||
| Intra-operative (Neuro.) | P | P | P | P | P | P | ||||
| Laparoscopic | P | P | P | P | P | P | ||||
| Pediatric | P | P | P | P | P | P | P | |||
| Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | ||||
| Neonatal Cephalic | P | P | P | P | P | P | ||||
| Fetal Imaging | ||||||||||
| & Other | Adult Cephalic | P | P | P | P | P | P | P | ||
| Trans-rectal | Ph | Ph | Ph | Ph | Ph | Ph | ||||
| Trans-vaginal | Pf | Pf | Pf | Pf | Pf | Pf | ||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skel. (Convent.) | P | P | P | P | P | P | ||||
| Musculo-skel. (Superfic.) | P | P | P | P | P | P | ||||
| Intra-luminal | ||||||||||
| Other (spec.) | ||||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P | ||
| Cardiac Pediatric | P | P | P | P | P | P | P | |||
| Trans esophageal (card.) | Pg | Pg | Pg | Pg | Pg | Pg | ||||
| Other (spec.) | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | P | P | ||
| Other (spec.) |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
P = Previously Cleared, K013723
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
**Amplitude Doppler, Harmonic Imaging and 3D Imaging,
Additional Comments:
System:
| 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 II - Includes Imaging for guidance of transrectal biopsy.
PLEASE DO NOT WRITE BELOW
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Broadon
(Division Sign Of Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number: K053258
Prescription Use
5
System: Transducer:
EUB-6500 EUP-B514
| titended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: | ||||
|---|---|---|---|---|
| A . A | 1.4000 - 4.0000 - 4.4 4.00 - 4.0 4.0 - 4.4 4.4 - 4.4 4.4 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| 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 | E | E | E | E | E | E | ||
| Abdominal | Ea | Ea | Ea | Ea | Ea | Ea | ||
| 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.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
E = Added under Appendix E
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
**Amplitude Doppler, 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, 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. |
Nancy C. Hogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number: K053258
Prescription Use
6
System: Transducer: EUB-6500
EUP-C312T
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 & II) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | E | E | E | E | E | E | ||
| Abdominal | Ea | Ea | Ea | Ea | Ea | Ea | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | E | E | E | E | E | E | ||
| Small Organ (Spec.) | Ed | Ed | Ed | Ed | Ed | Ed | ||
| 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.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
E = Added under Appendix E
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
**Amplitude Doppler, 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, 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)
Nancyc broydon
(Division Sign-Off)
Division of Reproductive, Abdominal, H and Radiological Devices
510(k) Number: K053258
Prescription Use
7
System: Transducer
EUB-6500 EUP-C314G
| Intended use: Diagnostic ultrasound imaging of fluid flow analysis if the human body | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | ||||
| Doppler | Combined* | ||||||||
| (Spec.) | Other** | ||||||||
| (Spec.) | |||||||||
| General | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & III) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | E | E | E | E | E | E | |||
| Abdominal | Ea | Ea | Ea | Ea | Ea | Ea | |||
| Intra-operative (Spec.) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | E | E | E | E | E | E | |||
| Small Organ (Spec.) | Ed | Ed | Ed | Ed | Ed | Ed | |||
| 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.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) |
Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
E = Added under Appendix E
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
**Amplitude Doppler, Harmonic Imaging and 3D Imaging.
Additional Comments:
Additional Comments:
Subscript "a". Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures acial
| (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. |
pt "h"." Theludes maging for guidance of transiccan nepoly on ANG (ODE) WILL BELO ... Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Livision Sign-Off. I)ivision of Reproductive, Abdom and Radiological Device
510(k) Number: K053258
Prescription Use
8
System: Transducer: EUB-6500
EUP-C511
Mode of Operation Clinical Application Other** Combined* CWD Color PWD B M Specific General (Spec.) (Spec.) Doppler (Tracks I & III) (Track I only) Ophthalmic Ophthalmic E E E E E E Fetal Ea Ea Ea Ea Ea Abdominal Ea Intra-operative (Spec.) Intra-operative (Neuro.) Laparoscopic దా E E E E B Pediatric Small Organ (Spec.) Neonatal Cephalic Adult Cephalic Fetal Imaging Trans rectal & Other Trans-vaginal Trans-urethral Trans esoph. (non-Card.) Musculo skel. (Convent.) Musculo-skel. (Superfic.) Intra-luminal Other (spec.) E B E E E E Cardiac Adult E E E E E E Cardiac Pediatric Cardiac Trans-esophageal (card.) Other (spec.) E E E E E E Peripheral vessel Peripheral Other (spec.) Vessel
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
E = Added under Appendix E
E = Added under Appendix E
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
**Amplitude Doppler, Harmonic Imaging.
Additional Comments:
ments.
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdomi and Radiological Devices
510(k) Number
9
System: Transducer: EUB-6500
EUP-C516
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 | E | E | E | E | E | E | ||
| Abdominal | Ea | Ea | Ea | Ea | Ea | Ea | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | E | E | E | E | E | E | ||
| Small Organ (Spec.) | Ed | Ed | Ed | Ed | Ed | Ed | ||
| 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.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
E = Added under Appendix E
*Combination of each operating mode, B, M, PWI), CWD and Color Doppler.
** Amplitude Doppler, Harmonic 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. |
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive and Radiological Device
510(k) Number: K053258
... what might have been?
... what might be now?
10
System: Transducer:
EUB-6500 EUP-C524
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | E | E | E | E | E | E | ||
| Abdominal | E | E | E | E | E | E | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | E | E | E | E | E | E | ||
| Small Organ (Spec.) | E | E | E | E | E | E | ||
| 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.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows-
E = Added under Appendix E
*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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Nemarc Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number: K053258
11
System: Transducer:
EUB-6500 EUP-C532
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis in the human body as follows: | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | Ea | Ea | Ea | Ea | Ea | Ea | ||
| Intra-operative (Spec.) | Eb | Eb | Eb | Eb | Eb | Eb | ||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | E | E | E | E | E | E | ||
| Small Organ (Spec.) | Ed | Ed | Ed | Ed | Ed | Ed | ||
| Neonatal Cephalic | E | E | E | E | E | E | ||
| 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.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | E | E | E | E | E | E | |
| Other (spec.) | ||||||||
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows
E = Added under Appendix E
*Combination of each operating mode, B, M, PWD, CWI) and Color Doppler.
**Amplitude Doppler, Harmonic Imaging.
Additional Comments:
Includes imaging for guidance of percutancous 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. |
Nancy C. Broglon
(Division Sign-Off)
(Division Sign Off, Division of Reproductive, Abdominal, for and Radiological Devices
510(k) Number: K053258
Description Code
12
System: Transducer:
EUB-6500 EUP-CC531
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis in the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | ||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| (Track I only) | (Tracks I & III) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | E | E | E | E | E | E | ||
| Abdominal | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Adult Cephalic | |||||||
| Trans-rectal | Ee | Ee | Ee | Ee | Ee | Ee | ||
| Trans-vaginal | Ef | Ef | Ef | Ef | Ef | Ef | ||
| 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.) |
tended use. Diagnostic ultrasound imaging or fluid flow analysis if the human body as followsr.
E = Added under Appendix E
*Combination of cach operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler, Harmonic 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)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number: K053258
13
System: Transducer:
EUB-6500 EUP-CV524
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.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | ||
| Small Organ (Spec.) | N | N | N | N | N | N | N | ||
| 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.) | |||||||||
| Peripheral | |||||||||
| Vessel | 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 amniorentesis)
| (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)
Nancy C Hodgson
(Division Sign-Off)
Division of Reproductive, Abdom and Radiological Devices
510(k) Number: K053258
14
System: Transducer:
EUP-F334
EUB-6500
| istended use. Diagnostic ultrasound imaging or find 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.) | Eb | Eb | Eb | Eb | Eb | Eb | ||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) | E | E | E | E | E | E |
E = Added under Appendix E
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler, Harmonic 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)
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdomin and Radiological Devices
510(k) Number: K053258
✓
15
System: Transducer:
EUB-6500 EUP-L34T
| 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 | Ea | Ea | Ea | Ea | Ea | Ea | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | E | E | E | E | E | E | ||
| Small Organ (Spec.) | Ed | Ed | Ed | Ed | Ed | Ed | ||
| Neonatal Cephalic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | E | E | E | E | E | E | ||
| Musculo-skel. (Superfic.) | E | E | E | E | E | E | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | E | E | E | E | E | E | |
| Other (spec.) |
Diagnostic ultrasound imaging or fluid flow analysis if the human body as followsaded uao:
E = Added under Appendix E
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler, Harmonic 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)
Manue Bergdon
Division Sign-Off
(Division pign-Off) Division of Reproductive, Abdominal, ENF. and Radiological Devices
510(k) Number: 4053258
\
16
System: Transducer: EUB-6500
EUP-L52
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | ||||||||||
| (Track I only) | Specific | |||||||||
| (Tracks I & II) | B | M | PWD | CWD | Color | |||||
| Doppler | Combined* | |||||||||
| (Spec.) | Other** | |||||||||
| (Spec.) | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | Ea | Ea | Ea | Ea | Ea | Ea | ||||
| Intra-operative (Spec.) | ||||||||||
| Intra-operative (Neuro.) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | E | E | E | E | E | E | ||||
| Small Organ (Spec.) | Ed | Ed | Ed | Ed | Ed | Ed | ||||
| Fetal Imaging | ||||||||||
| & Other | Neonatal Cephalic | |||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skel. (Convent.) | E | E | E | E | E | E | ||||
| Musculo-skel. (Superfic.) | ||||||||||
| Intra-luminal | ||||||||||
| Other (spec.) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Trans-esophageal (card.) | ||||||||||
| Other (spec.) | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | E | E | E | E | E | E | |||
| Other (spec.) |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows
E = Added under Appendix E
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler, 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, 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)
Nancy C. Croydon
Division Sign-Off
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number: K053258
✓
17
System: Transducer: EUB-6500
EUP-L53
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis in 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 | Ea | Ea | Ea | Ea | Ea | Ea | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | E | E | E | E | E | E | ||
| Small Organ (Spec.) | Ed | Ed | Ed | Ed | Ed | Ed | ||
| Neonatal Cephalic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | E | E | E | E | E | E | ||
| Musculo-skel. (Superfic.) | E | E | E | E | E | E | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | E | E | E | E | E | E | |
| Other (spec.) |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
E = Added under Appendix E
*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. |
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdomin and Radiological Devices
510(k) Number: K052258
18
System: Transducer:
EUB-6500 EUP-L53L
| 'ntended use' Diagnostic ultrasound imaging or fluid flow analvsis 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 | E | E | E | E | E | E | |||
| Intra-operative (Spec.) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | E | E | E | E | E | E | |||
| Small Organ (Spec.) | Ec | Ec | Ec | Ec | Ec | Ec | |||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | |||||||||
| & Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | E | E | E | E | E | E | |||
| Musculo-skel. (Superfic.) | E | E | E | E | E | E | |||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | E | E | E | E | E | E | ||
| Other (spec.) |
E = Added under Appendix E
- Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
**Amplitude Doppler, Harmonic 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)
Nancy Chogdon
Division Sign Off Division of Reproductive, Abdominal, for and Radiological Devices
510(k) Number: K053258
19
System: Transducer:
EUB-6500 EUP-L65
| ntended 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 | E | E | E | E | E | E | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | E | E | E | E | E | E | ||
| Small Organ (Spec.) | Ec | Ec | Ec | Ec | Ec | Ec | ||
| Neonatal Cephalic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | E | E | E | E | E | E | ||
| Musculo-skel. (Superfic.) | E | E | E | E | E | E | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | E | E | E | E | E | E | |
| Other (spec.) |
E = Added under Appendix E
*Combination of each operating mode, B, M, PWD, CWI) and Color Doppler.
**Amplitude Doppler, Harmonic 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. |
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, EA and Radiological Devices
510(k) Number: K053258
20
System: Transducer:
EUB-6500 EÜP-O53T
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.) | Eb | Eb | Eb | Eb | Eb | Eb | ||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| 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.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
E = Added under Appendix E
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler, Harmonic 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. |
Nancy Brogdon
(Division Sign Off)
Division of Reproductive, and Radiological Dev
510(k) Number: K053258
21
System: Transducer:
EUB-6500 EUP-R54A-19
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | | B | M | PWD | CWD | Color
Doppler | Combined*
(Spec.) | Other**
(Spec.) |
|---------------------------|------------------------------|---|---|-----|-----|------------------|----------------------|--------------------|
| General
(Track I only) | Specific
(Tracks I & III) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging
& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Spec.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | E | E | E | | E | E | E |
| | 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.) | | | | | | | |
E = Added under Appendix E
*Combination of each operating mode, B, M, PWI), CWD and Color Doppler.
**Amplitude Doppler, Harmonic Imaging.
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures Subscript "a": 10101
| (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. |
Nancy C Brogdon
Division Sign-Off
Division of Reproductive, Abdom: and Radiological Device
510(k) Number: KA053258
\
22
System: Transducer:
EUB-6500 EUP-R54A-33 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
·
| ' ~tended use: Diagnostic ultrasound imaging or fluid flow analysis if the human bodv 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.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Adult Cephalic | |||||||
| Trans-rectal | E | E | E | E | E | E | ||
| 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.) |
E = Added under Appendix E
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler, Harmonic 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. |
(Division Sign-Off) Division of Reproductive, Abdominal, ENF and Radiological Devices
510(k) Number: K053258
23
System: Transducer:
EUB-6500 EUP-R54AW-19
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis in the human body as follows: | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | Color | Combined* | Other** | |||||
| General | Specific | B | M | PWD | CWD | Doppler | (Spec.) | (Spec.) |
| (Track I only) | (Tracks I & III) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging | Adult Cephalic | |||||||
| & Other | Trans-rectal | E | E | E | E | E | E | |
| 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 | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
ostic ultrasound imaging or fluid flow analysis if the human body as follows ni
E = Added under Appendix E
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
**Amplitude Doppier, Harmonic 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) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Hodgson
(Division Sign-C Division of Reproductive, Abdominal, B and Radiological Devices
510(k) Number: K053258
24
System: Transducer
EUB-6500 EUP-R54AW-33
| 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.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Adult Cephalic | E | ||||||
| Trans-rectal | E | E | E | E | E | E | ||
| 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.) |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
E = Added under Appendix E
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler, Harmonic 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Hogdon
(Division Sign-Off)
Division of Reproductive, Abdom and Radiological Devices
510(k) Number: K053258
25
System: Transducer: EUB-6500
EUP-S50
Intended use Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows i
| 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 | E | E | E | E | E | E | E | ||
| Abdominal | Ea | Ea | Ea | Ea | Ea | Ea | Ea | ||
| Intra-operative (Spec.) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | E | E | E | E | E | E | E | ||
| Small Organ (Spec.) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | |||||||||
| & Other | Adult Cephalic | E | E | E | E | E | E | E | |
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac | Cardiac Adult | E | E | E | E | E | E | E | |
| Cardiac Pediatric | E | E | E | E | E | E | E | ||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | E | E | E | E | E | E | E | |
| Other (spec.) | |||||||||
E = Added under Appendix E
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler, Harmonic Imaging.
Additional Comments
ments.
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures Subscript "a": tacial
| (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. |
Nancy Brogdon
(Division Sign-0 Division of Reproductive, Abdominal, EN and Radiological Devices
510(k) Number: A053258
26
System: Transducer:
EUB-6500 EUP-S50A
| 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 | Color | ||||
| Doppler | Combined* | ||||||||
| (Spec.) | Other** | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | E | E | E | E | E | E | E | ||
| Abdominal | E | E | E | E | E | E | E | ||
| Intra-operative (Spec.) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | E | E | E | E | E | E | E | ||
| Small Organ (Spec.) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | |||||||||
| & Other | Adult Cephalic | E | E | E | E | E | E | E | |
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac | Cardiac Adult | E | E | E | E | E | E | E | |
| Cardiac Pediatric | E | E | E | E | E | E | E | ||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | E | E | E | E | E | E | E | |
| Other (spec.) |
E = Added under Appendix E
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
**Amplitude Doppler, Harmonic 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. |
Nancy C Brogdon
Division Sign Off) Division of Reproductive, Abdominal, ENA and Radiological Devices
510(k) Number: K053258
27
System: Transducer: EUB-6500
EUP-S52
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 | Color | Combined* | Other** |
| (Track I only) | (Tracks I & III) | Doppler | (Spec.) | (Spec.) | ||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | E | E | E | E | E | E | E | |
| Small Organ (Spec.) | Ec | Ec | Ec | Ec | Ec | Ec | Ec | |
| Neonatal Cephalic | ||||||||
| Fetal Imaging | Adult Cephalic | |||||||
| & Other | 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 | E | E | E | E | E | E | E | |
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
E = Added under Appendix E
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler, Harmonic 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. |
Includes imaging for guidance of transrectal biopsy. Subscript "h": (PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdommal, E. and Radiological Devices
510(k) Number: K053258
✓
28
System: Transducer
EUB-6500 Fujinon SP711
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | ||||||||
| 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.) | ||||||||
| 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 | E | |||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
tended use. Diagnostic ultrasound imaging or fluid flow analysis if the human body as followsт.
E = Added under Appendix E
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler, Harmonic 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. |
Includes imaging for guidance of transrect (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdom mal H and Radiological Devices
510(k) Number: K1053258