(166 days)
Not Found
No
The document describes a standard diagnostic ultrasound system with various imaging modes and does not mention any AI or ML capabilities.
No
The device is described as a "Diagnostic Ultrasound Scanner" used for "Diagnostic ultrasound imaging or fluid flow analysis," indicating its purpose is for diagnosis, not therapy.
Yes
The device description explicitly states, "The Hitachi EUB-5500 Diagnostic Ultrasound Scanner is a Track 3 Diagnostic Ultrasound Pulsed Doppler and Pulsed Echo Imaging System". Additionally, the intended use section describes "Diagnostic ultrasound imaging or fluid flow analysis", which directly indicates its diagnostic purpose.
No
The device description explicitly states it is a "Diagnostic Ultrasound Scanner" and a "Pulsed Doppler and Pulsed Echo Imaging System," which are hardware-based medical devices, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health.
- Device Function: The description clearly states this device is a "Diagnostic Ultrasound Scanner." Ultrasound imaging works by sending sound waves into the body and interpreting the echoes to create images of internal structures. It does not involve analyzing specimens taken from the body.
- Intended Use: The intended use describes imaging and fluid flow analysis within the human body for various anatomical sites. This is consistent with an in-vivo (within the living body) diagnostic device, not an in-vitro one.
Therefore, based on the provided information, this device is a diagnostic ultrasound system used for imaging the human body directly, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
Diagnostic ultrasound imaging or fluid flow analysis if the human body
Product codes (comma separated list FDA assigned to the subject device)
IYO, IYN, ITX
Device Description
The Hitachi EUB-5500 Diagnostic Ultrasound Scanner is a Track 3 Diagnostic Ultrasound Pulsed Doppler and Pulsed Echo Imaging System capable of the following operating functions:
- B Mode .
- M Mode .
- . Pulsed Doppler Color Flow
- . Continuous Wave Doppler
- . Amplitude Doppler
- . Harmonic imaqing
- . Superficial musculoskeletal imaging
- t 3D imaging
- . 4D imaging
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
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, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel.
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).
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
Image /page/0/Picture/0 description: The image shows the words "K061608" in a handwritten-like font at the top. Below that is the word "HITACHI" in a bold, sans-serif font. Underneath that is the phrase "Summary of Safety and Effectiveness" in a smaller, regular font. The text appears to be part of a document or report.
Device Description
The Hitachi EUB-5500 Diagnostic Ultrasound Scanner is a Track 3 Diagnostic Ultrasound Pulsed Doppler and Pulsed Echo Imaging System capable of the following operating functions:
- B Mode .
- M Mode .
- . Pulsed Doppler Color Flow
- . Continuous Wave Doppler
- . Amplitude Doppler
NOW 2 2 2006
- . Harmonic imaqing
- . Superficial musculoskeletal imaging
- t 3D imaging
- . 4D imaging
Safety
.
As a Track 3 ultrasound device, the Hitachi EUB-5500 Diagnostic Ultrasound Scanner complies with the Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (1992) - published by NEMA as UD-3.
With respect to limits on acoustic outputs, the Hitachi EUB-5500 Diagnostic Ultrasound Scanner complies with the guideline limits set in the 510(k) Diagnostic Ultrasound Guidance -- Revision: April 14, 1994.
With regard to general safety, the Hitachi EUB-5500 Diagnostic Ultrasound Scanner is designed to comply with IEC 606601-1 (1998) Medical Electrical Equipment, Part 1 - General Requirements for Safety.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1 2007
Mr. Douglas J. Thistlethwaite Manager of Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087
Re: K061608
Trade Name: EUB-5500 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 Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYO, IYN, and ITX Dated: December 1, 2006 Received: December 4, 2006
Dear Mr. Thistlethwaite:
This letter corrects our substantially equivalent letter of November 22, 2006.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include 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 EUB-5500 Diagnostic Ultrasound Scanner, as described in your premarket notification:
2
Transducer Model Number
EUP-B314 EUP-B512 EUP-C314G EUP-C516 EUP-C524 EUP-CC531 EUP-CV524 EUP-F334 EUP- L34T EUP-L52 EUP-L53 EUP-L53L EUP-L65 EUP-R53W EUP-R54AW-19.-33 EUP-S50A EUP-S52 Fujinon SP711
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
3
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), 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 (240) 276-3150 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 John Chen at (240) 276-3666.
Sincerely yours,
Helut lemer wo
Image /page/3/Picture/6 description: The image shows the handwritten word "for" in cursive. The letters are connected, and the word is written in a flowing style. The writing appears to be done with a pen or marker, and the ink is dark. The image is simple and focuses solely on the word itself.
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
4
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 | 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 | E | |||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P |
| Cardiac Pediatric | P | P | P | P | P | P | P | |
| Trans-esophageal (card.) | P | P | P | P | P | P | ||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | P | P |
| Other (spec.) |
P = Previously Cleared, K032503; 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:
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": | Includes imaging for guidance of trans perineal biopsy. |
| 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)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number: K041608
Prescription Use
(Per 21 CFR 801.109)
B3
C
5
System:
EUB-5500 EUP-B314 Transducer:
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | 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": Includes imaging for guidance of trans perineal biopsy. |
| 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)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, | |
| and Radiological Devices |
8661608 510(k) Number:
Prescription Use
(Per 21 CFR 801.109)
6
System: Transducer'
EUR-5500 EUP-B512
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 | |||||||||
| Small Organ (Spec.) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | |||||||||
| & Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Trans esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| 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": | Includes imaging for guidance of trans-perineal biopsy. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| | (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED) |
E-CONTINUE ON ANOTHER PAGE IF NEEDED) TIT DELV Concurrence of CDRH, Office of Device Evaluation (ODE)
text
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number: K061408
Prescription Use
(Per 21 CFR 801.109)
7
System: Transducer:
EUB-5500 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 | 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 | 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 and 3D Imaging.
Additional Comments:
| 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": | Includes imaging for guidance of trans-perineal biopsy. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy |
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
| (Division Sign-Off) |
|---|
| Division of Reproductive, Abdominal, ENT, |
| and Radiological Devices |
510(k) Number: K061608
Prescription Use
(Per 21 CFR 801.109)
8
System: Transducer: EUB-5500
EUP-C516
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 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
*Comhination 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": | Includes imaging for guidance of trans perineal biopsy. |
| 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)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K061608
Prescription Use _ (Per 21 CFR 801.109)
9
System: Transducer: EUB-5500
EUP-C524
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 | 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.) | ||||||||
| 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 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": | Includes imaging for guidance of trans perineal biopsy. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | |
| (Division Sign-Off) |
|---|
| Division of Reproductive, Abdominal, ENT, |
| and Radiological Devices |
510(k) Number: K061608
Prescription Use
(Per 21 CFR 801.109)
10
System: Transducer:
EUB-5500 EUP-CC531
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 | E | E | E | E | E | E | |
| Abdominal | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| 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.) |
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": | Includes imaging for guidance of trans perineal biopsy. |
| 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)
| (Division Sign-Off) |
|---|
| Division of Reproductive, Abdominal, ENT, |
| and Radiological Devices |
510(k) Number: K061608
Prescription Use (Per 21 CFR 801.109)
11
System: Transducer:
2024-01-11 Completed
EUB-5500
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 | ||
| Abdominal | N | N | N | N | N | N | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | ||
| Small Organ (Spec.) | Nc | Nc | Nc | Nc | Nc | Nc | ||
| 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 | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
**Amplitude Doppler, Harmonic Imaging and 3D Imaging.
Additional Comments
| 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": | Includes imaging for guidance of trans perineal biopsy. |
| 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)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number: K061608
Prescription Use
(Per 21 CFR 801.109)
(Per 21 CFR 801.109)
12
System: Transducer:
EUB-5500 EUP-F334
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 | E | E | E | E | E | E | ||
| Small Organ (Spec.) | Ec | Ec | Ec | Ec | Ec | Ec | ||
| Neonatal Cephalic | E | E | E | E | E | E | ||
| Fetal Imaging | ||||||||
| & Other | Adult Cephalic | |||||||
| Trans-rectal | E | E | E | E | E | E | ||
| Trans-vaginal | E | E | E | E | E | E | ||
| 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.) |
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": | Includes imaging for guidance of trans-perineal biopsy. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) LASE DU NU Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K061608
Prescription Use (Per 21 CFR 801.109) V
13
System: Transducer:
EUB-5500 EUP-L34T
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 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.) |
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": | Includes imaging for guidance of trans perineal biopsy. |
| 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)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K061608
Prescription Use
(Per 21 CFR 801.109)
ાવડો
14
System: Transducer: EUB-5500
BUP-L52
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.) | ||||||||
| 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, 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": | Includes imaging for guidance of trans perineal biopsy. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (PLEASE DO NOT
| (Division Sign-Off) |
|---|
| Division of Reproductive, Abdominal, ENT, |
| and Radiological Devices |
510(k) Number: K061609
Prescription Use
(Per 21 CFR 801.109)
15
System: Transducer: EUB-5500 EUP-L53
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 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 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": | Includes imaging for guidance of trans perineal biopsy. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices vices
510(k) Number: K061608
Prescription Use
(Per 21 CFR 801.109)
16
System:
Transducer: EUP-L53L
EUB-2500
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 | 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:
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": | Includes imaging for guidance of trans-perineal biopsy. |
| 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)
| (Division Sign-Off) |
|---|
| Division of Reproductive, Abdominal, ENT, |
| and Radiological Devices |
510(k) Number: K061608
Prescription Use
(Per 21 CFR 801.109)
17
System: Transducer:
EUB-5500 EUP-L65
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 | 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 | ||||||||
| 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, CWD and Color Doppler.
** Amplitude Doppler, Harmonic Imaging.
Additional Comments:
| 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": | Includes imaging for guidance of trans-perineal biopsy. |
| 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)
| (Division Sign-Off) |
|---|
| Division of Reproductive, Abdominal, ENT, |
| and Radiological Devices |
510(k) Number: K061608
Prescription Use
(Per 21 CFR 801.109)
ીવ્યુદ્
18
System: Transducer: EUB-5500
EUP-R53W
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 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:
| 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": | Includes imaging for guidance of trans perineal biopsy. |
| 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)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, | |
| and Radiological Devices | |
| 510(k) Number: | K061608 |
Prescription Use
(Per 21 CFR 801.109)
19
System: Transducer
EUP-R54AW-19, -33
EUB-5500
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 | 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.) |
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.
Includes imaging for guidance of trans perineal biopsy. Subscript "g": Subscript "h": Includes imaging for guidance of transrectal biopsy.
(PLEASE DO NOT WRITE BELQW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K061608
Prescription Use
(Per 21 CFR 801.109)
20
System: Transducer:
EUB-5500 EUP-S50A
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 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:
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": | Includes imaging for guidance of trans perineal biopsy. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |
| (Division Sign-Off) |
|---|
| Division of Reproductive, Abdominal, ENT, |
| and Radiological Devices |
510(k) Number: K061609
Prescription Use
(Per 21 CFR 801.109)
21
System: Transducer:
EUB-5500 BUP-S52
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.) | |||||||||
| 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:
| 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": | Includes imaging for guidance of trans perineal biopsy. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BETOW THIS LINE CONTINUE ON ANQTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: Kol61608
Prescription Use
(Per 21 CFR 801.109)
22
System: Transducer:
EUB-5500 Fujinon SP711
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 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.) | ||||||||
| 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 | E | |||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
E = Added under Appendix E
*Comhination 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
| 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": | Includes imaging for guidance of trans-perineal biopsy. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| (Division Sign-Off) |
|---|
| Division of Reproductive, Abdominal, ENT, |
| and Radiological Devices |
510(k) Number: K061608
Prescription Use _
(Per 21 CFR 801.109) ✓