(30 days)
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
Intended use. Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
The Hitachi HI VISION 900 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 Wave Doppler
- Continuous Wave Doppler
- Color Flow
- Amplitude Doppler
- Harmonic imaging
- 3D imaging
This document is an FDA 510(k) premarket notification letter for the Hitachi HI VISION 900 Diagnostic Ultrasound Scanner and several associated transducers. It primarily focuses on demonstrating substantial equivalence to previously marketed devices and establishing the intended uses for each transducer with different clinical applications and operating modes.
The document does NOT contain information about specific acceptance criteria or performance studies in the way typically found for a new medical device claiming novel clinical performance metrics. Instead, the acceptance criteria are implicitly tied to the regulatory requirements for substantial equivalence, specifically compliance with established standards for diagnostic ultrasound equipment and its acoustic output, and demonstration of equivalency in intended use to predicate devices.
Therefore, many of the requested elements for a performance study are not explicitly present in this type of regulatory document. I will extract the available information and explicitly state where information is not provided.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for Hitachi HI VISION 900 Diagnostic Ultrasound Scanner
This document primarily outlines the regulatory clearance for the Hitachi HI VISION 900 Diagnostic Ultrasound Scanner based on substantial equivalence to predicate devices, rather than detailing a specific clinical performance study with acceptance criteria and a detailed analysis of device performance against those criteria.
The "acceptance criteria" here are implicitly meeting the regulatory standards for diagnostic ultrasound systems and demonstrating that the device and its transducers are safe and effective for their intended uses, comparable to legally marketed predicate devices.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implicit from Regulatory Context) | Reported Device Performance (as per 510(k) Clearance) |
|---|---|
| Safety: | Compliance Confirmed: |
| a) Compliance with Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (1992) - NEMA UD-3. | The Hitachi HI VISION 900 Diagnostic Ultrasound Scanner complies with NEMA UD-3 regarding thermal and mechanical acoustic output indices. (Stated as a Track 3 device) |
| b) Compliance with guideline limits set in the 510(k) Diagnostic Ultrasound Guidance - Revision: April 14, 1994, for acoustic outputs. | The Hitachi HI VISION 900 Diagnostic Ultrasound Scanner complies with the guideline limits for acoustic outputs in the 510(k) Diagnostic Ultrasound Guidance (1994). |
| c) Compliance with IEC 60601-1 (1998) Medical Electrical Equipment, Part 1 - General Requirements for Safety. | The Hitachi HI VISION 900 Diagnostic Ultrasound Scanner complies with IEC 60601-1 (1998) for general safety requirements. |
| Effectiveness/Intended Use: | Substantial Equivalence Demonstrated for Listed Intended Uses: The FDA reviewed the 510(k) and determined the device is substantially equivalent for the stated indications for use (diagnostic ultrasound imaging or fluid flow analysis of the human body) to legally marketed predicate devices. Specific indications for use (Clinical Application and Mode of Operation) are listed per transducer model. |
| a) Device demonstrates intended functions: B Mode, M Mode, Pulsed Wave Doppler, Continuous Wave Doppler, Color Flow, Amplitude Doppler, Harmonic imaging, Superficial musculoskeletal imaging, 3D imaging. | The device is capable of these operating functions. The FDA's clearance implies that the performance of these modes is acceptable for diagnostic purposes, in line with predicate devices. |
| b) Each listed transducer (e.g., EUP-B514, EUP-F531, EUP-850, EUP-C514, EUP-L53S, EUP-TC3, EUP-C532, EUP-L65, EUP-U533, EUP-CC531, EUP-053T, EUP-V53W, EUP-CV524, EUP-OL334, EUP-ES52M, EUP-R54AW-19, -33) is cleared for its specified clinical applications and modes of operation. | A detailed table is provided for each transducer model, listing the specific clinical applications (e.g., Fetal, Abdominal, Pediatric, Small Organ, Cardiac Adult, Peripheral vessel) and the modes of operation (B, M, PWD, CWD, Color Doppler, Combined, Amplitude Doppler, Harmonic Imaging, 3D Imaging) for which it has been cleared (indicated by 'P' for previous indication or 'N' for new indication). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This document does not provide information on a specific test set sample size or data provenance (country of origin, retrospective/prospective) for a performance study. 510(k) submissions for ultrasound devices primarily rely on engineering performance testing (acoustic output, electrical safety, EMC) and comparison to predicate devices, rather than extensive clinical efficacy studies with patient data for primary clearance. The "performance" assessment here refers to the device's ability to operate according to its specifications and regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not provided as this document does not detail a clinical study where expert ground truth was established for image interpretation. The "ground truth" for regulatory clearance pertains to adherence to established engineering standards and guidelines for ultrasound equipment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided as this document does not refer to a clinical test set requiring adjudication of findings.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This document is from 2006, pre-dating widespread integration of AI in diagnostic ultrasound for which MRMC studies are commonly conducted. Therefore, no MRMC comparative effectiveness study involving AI assistance was performed or reported in this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This document describes a diagnostic ultrasound scanner, which is a human-operated imaging device. It does not describe an AI algorithm or a standalone algorithmic performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this 510(k) clearance, the "ground truth" is based on engineering performance specifications, compliance with recognized national and international standards (NEMA UD-3, IEC 60601-1), and comparison to functional attributes of legally marketed predicate devices. It does not involve clinical "ground truth" from expert consensus, pathology, or outcomes data in the context of a clinical performance study.
8. The sample size for the training set:
As this document does not pertain to an AI algorithm, there is no training set and therefore no sample size provided.
9. How the ground truth for the training set was established:
As there is no training set for an AI algorithm, this information is not applicable and not provided.
{0}------------------------------------------------
Device Description
The Hitachi HI VISION 900 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 Wave Doppler
-
. Continuous Wave Doppler
-
. Color Flow
-
. Amplitude Doppler
-
Harmonic imaging .
-
. Superficial musculoskeletal imaging
-
. 3D imaging
Safety
As a Track 3 ultrasound device, the Hitachi HI VISION 900 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 HI VISION 900 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 HI VISION 900 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 depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1
DEC 2 1 2006
Mr. Douglas J. Thistlewaite Manager of Regulatory Affairs HITACHI Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087-2371
Re: K063518
Trade Name: HI VISION 900 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: IYN, IYO, and ITX Dated: November 20, 2006 Received: November 21, 2006
Dear Mr. Thistlewaite:
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 HI VISION 900 Diagnostic Ultrasound Scanner, as described in your premarket notification:
Image /page/1/Picture/11 description: The image shows a circular logo with the letters "FDA" in bold, stylized font at the center. Above the letters, the years "1906-2006" are printed. Below the letters, the word "Centennial" is written in cursive. The logo is surrounded by text that reads "A CENTURY OF SERVICE TO CONSUMER PROTECTION & HEALTH IN THE SCIENCE OF FOODS". The logo appears to be a commemorative emblem, possibly celebrating the 100th anniversary of an organization.
Protecting and Promoting Public Health
{2}------------------------------------------------
Transducer Model Number EUP-B514 EUP-F531 EUP-850 EUP-C514 EUP-L53S EUP-TC3 EUP-C532 EUP-L65 EUP-U533 EUP-CC531 EUP-053T EUP-V53W EUP-CV524 EUP-OL334 EUP-ES52M EUP-R54AW-19, -33
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:
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.
le
{3}------------------------------------------------
Page 2 - Mr. Thistlewaite
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 Andrew Kang at (240) 276-3666.
Sincerely yours,
David A. Segura
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM 006 NOTSTA IH
| Clinical Application | Mode of Operation | Other**(Spec.) | ||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | |
| Ophthalmic | Ophthalmic | N | N | N | N | N | N | N |
| Fetal | N | N | N | N | N | N | N | |
| Abdominal | Na | Na | Na | Na | Na | Na | Na | |
| Intra-operative (Spec.) | Nb | Nb | Nb | Nb | Nb | Nb | ||
| Intra operative (Neuro.) | ||||||||
| Laparoscopic | N | N | N | N | N | N | ||
| Pediatric | N | N | N | N | N | N | N | |
| Small Organ (Spec.) | Nd | Nd | Nd | Nd | Nd | Nd | ||
| Neonatal Cephalic | N | N | N | N | N | N | ||
| Fotal Imaging& Other | Adult Cephalic | N | N | N | N | N | N | N |
| Trans rectal | Nh | Nh | Nh | Nh | Nh | Nh | ||
| Trans-vaginal | Nf | Nf | Nf | Nf | Nf | Nf | ||
| Trans-urethral | ||||||||
| Trans esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | N | N | ||
| Musculo-skel. (Superfic.) | N | N | N | N | N | N | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N |
| Cardiac Pediatric | N | N | N | N | N | N | N | |
| Trans esophageal (card.) | Ng | Ng | Ng | N | Ng | Ng | Ng | |
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | N | N | N |
| Other (spec.) |
Intended use. Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
N = new indication, P = previous indication
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Dopplor, Harmonic Imaging and 3D Imaging.
Additional Comments:
System:
Includes imaging for guidance of percutaneous biopay 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. |
An a paran A DEBOY
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K063518
David R. Hyman
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109)
647089808814
BRITEMA SMATEVS lesibeM idaesiH-mori
me 2p : 7 |
{5}------------------------------------------------
System: HI VISION 900
Transducer: EUP-B514
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Abdominal | Pa | Pa | P | Pa | Pa | Pa | ||
| 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.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human hody as follows
N = new indication, P = previous indication
*Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler and Harmonic Imaging
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures(including amniocentesis). |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery(excluding neurosurgery and laparoscopic procedures). |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, 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. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number: K063518
David A. Lygum
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
Prescription Use (Per 21 CFR 801.109)
6720E960868889
ше Zy:Z |
{6}------------------------------------------------
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM 06 NOTERS H
System: Transducer:
EUP-C514
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | P | P | P | P | P | P | |
| Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
Intended use. Diagnostic ultragound imaging or fluid flow analysis if the human body as follows
N = new indication, P = previous indication
- Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler, Harmonic Imaging and 3D Imaging,
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures Subscript "a": (including amniocentesis).
| Subscript "b": Includes imaging of organs and structures exposed during surgery(excluding neurosurgery and laparoscopic procedures). |
|---|
| Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": For pediatric patients. |
| Subscript "h": Includes imaging for guidance of transrectal biopsy. |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K063518
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K06351
Prescription Use (Per 21 CFR 801,109)
44706880000114
180178mA 2metry2 leaibeM idastin-mori 90-61-200 me2☆:Z}
{7}------------------------------------------------
System -Transduce:
| HI VISION 900 | |
|---|---|
| EUP-C532 |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | ||
| Intra-operative (Spec.) | Pb | Pb | Pb | Pb | Pb | Pb | ||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | 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 | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P | |
| Other (spec.) |
Intended use. Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows
N = new indication, P = previous indication
*Combination of each operating mode, B, M. PWD and Color Doppler.
** Amplitude Doppler and Harmonic Imaging
Additional Comments:
Subscript "Includes imaging for guidance of percutaneous biopoy 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) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT. and Radiological Devices
510(k) Number: K063518
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063518
Prescription Use (Per 21 CFR 801.109)
1997 1977 1991 1991 18 189 1991 1991 19 90-61-200 12:488mm
{8}------------------------------------------------
System Transducer:
006 NOTSION 900 EUP-CC531
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | FWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging& Other | FetalAbdominalIntra operative (Spec.)Intra-operative (Neuro.)LaparoscopicPediatricSmall Organ (Spec.)Neonatal Cephalic | P | P | P | P | P | P | ||
| Adult CephalicTrans-rectalTrans-vaginalTrans-urethralTrans-esoph. (non-Card.)Musculo-skel. (Convent.)Musculo-skel. (Superfic.) | PePf | PePf | PePf | PePf | PePf | PePf | |||
| Intra-luminalOther (spec.) | |||||||||
| Cardiac | Cardiac AdultCardiac PediatricTrans-esophageal (card.)Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vesselOther (spec.) |
Intended use: Diagnostic ultrasound inaging or fluid flow analysis if the human body as follows
N = new indication, P = previous indication
*Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler and 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. |
WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED (FLEASE DO MO) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K063518
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number 2063518
Prescription Use (Per 21 CFR 801.109)
ની
{9}------------------------------------------------
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM 006 NOTSION 900
System: Transducer:
CUP-CV524
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Spec.) | P | P | P | P | P | P | ||
| Neonatal Cephalic | ||||||||
| Fetal Imaging& Other | Adult Cephalic | |||||||
| Trans rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
Intended use' Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows
N = new indication, P = previous indication
- Combination of each operating mode, B, M, PWD 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. |
WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED PLEASE DO NOT
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K063518
David h. Segram
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109)
1688-1 020/800 . 9 EBO-T - 677069606800814
so irema smetzy s les ibel interit-mori שפיל : קישורים 90-61-200
{10}------------------------------------------------
Transducer: EUP ES52M
System:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra operative (Spec.) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Spec.) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging& Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (card.) | P | P | P | P | P | P | P | ||
| Other (spec.) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (spec.) |
N = new indication, 1' = previous indication
*Combination of each operating mode. B. M. PWD, CWD and Color Doppler.
** Amplitude Doppler
Additional Comments'
Subscript "g" Includes imaging for guidance of percutancous 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) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K063518
David A. Ingram
(Division Sign-Off)
Division of Reproductive, Abdomi and Radiological Devices 510(k) Number _
Prescription Use (Per 21 CFR 801, 109)
{11}------------------------------------------------
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM 006 NOTSION 900
Transducer: EUP-F531
System -
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| FetalAbdominal | P | P | P | P | P | P | ||
| Intra-operative (Spec.) | Pb | Pb | Pb | Pb | Pb | Pb | ||
| Intra operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Spec.) | Pc | Pc | Pc | Pc | Pc | Pc | ||
| Neonatal Cephalic | P | P | P | P | P | P | ||
| Fetal Imaging | Adult Cephalic | |||||||
| & Other | Trans-rectal | P | P | P | P | P | P | |
| Trans vaginal | P | P | P | P | P | P | ||
| 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 | P | P | P | P | P | P | |
| Vessel | Other (spec.) |
Intended use: Diagnostic ultrasound imaging or fluid flow enalysis if the human body as follows:
N = new indication, P = previous indication
- Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler and Harmonic Imaging.
Additional Comments: Stibscript "4": ۲۰۰۵۱۰۰۵
| 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. |
S LINE-CONTINUE ON ANOTHER PAGE IF NEEDED ALLE, BALLOW
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number:
David A. Bergmann
KO6351
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .
Prescription Use (Per 21 CFR 801.109)
:
{12}------------------------------------------------
System' Transduce
| HI VISION 900 |
|---|
| EUP-L53S |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Fetal Imaging& Other | Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | |
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| 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 Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | P | |
| Vessel | Other (spec.) |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows
N = new indication, P = previous indication
- Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler, Harmonic Imaging and 3D Imaging,
Additional Comments:
Subscript "A" Includes imaging for guidance of perculaneous 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. |
WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (PLEASE DO NOT Concurrence of CDRH. Office of Device Evaluation (ODE)
Division Sign-Off Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K063518
David R. Lehman
(Division Sign-Off) Onliston of Reproductive, Abdom ann Radiological Devices 5114k) Number _
Preseription Use (Per 21 CFR 801.109)
। ୧୫---020/210.9 £80-1 BATOEGROEE I +
soilema smatzy2 feaibeM idastiH-mor7 12:44am 80-61-200
{13}------------------------------------------------
System: Transducer:
EUP-LG5
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | P | P | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Spec.) | Pc | Pc | Pc | Pc | Pc | Pc | ||
| Neonatal Cephalic | ||||||||
| Fetal Imaging& Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethra) | ||||||||
| 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 Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P | |
| Other (spec.) |
Intended use. Dirasound imaging or fluid flow analysis if the human body as follows:
N = new indication, P = previous indication
*Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler and Harmonic Imaging.
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures(including amniocentesis). |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery(excluding neurosurgery and laparoscopic procedures). |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, 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": ipt "h": Includes imaging for guidance of transectal biopay.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEBDED
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUED ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K063518
David R. Segmen
(Division Sign-Off)
Division of Reproductive, Abdomin and Radiological Devices 510(k) Number ___
Prescription Use (Per 21 CFR 801.109)
Ania Sales Saletses Tesibel infortill-mori
ાજે
{14}------------------------------------------------
System: 006 NOISION 900
Transducer: EUP-0531
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| FetalAbdominal | ||||||||
| Fetal Imaging& Other | Intra-operative (Spec.)Intra-operative (Neuro.) | Pb | Pb | Pb | Pb | Pb | Pb | |
| LaparoscopicPediatric | ||||||||
| Small Organ (Spec.)Neonatal Cephalic | ||||||||
| Adult CephalicTrans-rectal | ||||||||
| Trans-vaginalTrans-urethral | ||||||||
| Trans-esoph. (non-Card.)Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.)Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac AdultCardiac Pediatric | |||||||
| Trans-esophageal (card.)Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vesselOther (spec.) |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: | |
|---|---|
| -------------------------------------------------------------------------------------------------- | -- |
N = new indication, P = previous indication
- Combination of each operating mode, B, M. PWD and Color Doppler.
** Amplitude Doppler and Harmonic Imaging.
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures(including amniocentesis). |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery(excluding neurosurgery and laparoscopic procedures). |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, 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. |
WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED CLEASE DO NOT Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number: K063518
David Ch. Lyonn
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
Prescription Use (Per 21 CFR 801.109)
| 88-3 020/410.9 180-1 647069808814
so inema smetzy si system idae substil-mori
14
Dac-18-06
12:44am
{15}------------------------------------------------
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM 006 NOTSION 900
System: Transducer: EUP-OL334
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other **(Spec.) | ||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative (Spec.) | ||||||||||
| Intra-operative (Neuro.) | ||||||||||
| Laparoscopic | P | P | P | P | P | P | ||||
| Pediatric | ||||||||||
| Small Organ (Spec.) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Fetal Imaging& Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skel. (Convent.) | ||||||||||
| Musculo-skel. (Superfic.) | ||||||||||
| Intra-luminal | ||||||||||
| Other (spec.) | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Trans-esophageal (card.) | ||||||||||
| Other (spec.) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Other (spec.) |
Intended use . Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
N = new indication, P = previous indication
"Combination of each operating mode, B, M, PWD and Color Doppler.
**Amplitude Doppler
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures(including amniocentesis). |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery(excluding neurosurgery and laparoscopic procedures). |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS 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:
Eirid la Segmen
(Division Sign-Off)
Division of Reproductive, Abdo and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109)
। ୧୫-୨ 020/810 d E80-T
sa
{16}------------------------------------------------
System: Transducer:
006 NOISION 900 EUP-R54AW-19, -33
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | FetalAbdominalIntra-operative (Spec.)Intra-operative (Neuro.)LaparoscopicPediatricSmall Organ (Spec.)Neonatal CephalicAdult CephalicTrans rectalTrans vaginalTrans-urethralTrans-esoph. (non-Card.)Musculo-skel. (Convent.)Musculo-skel. (Superfic.)Intra-luminalOther (spec.) | P | P | P | P | P | P | |
| Cardiac | Cardiac AdultCardiac PediatricTrans esophageal (card.)Other (spec.) | |||||||
| PeripheralVessel | Peripheral vesselOther (spec.) |
Intended use. Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows
N = new indication, P = previous indication
*Combination of each operating mode, B, M, PWD and Color Doppler.
**Amplitude Doppler and Harmonic Imaging.
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures(including amniocentesis). |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery(excluding neurosurgery and laparoscopic procedures). |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, 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)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number: | K063618 |
|---|---|
| ---------------- | --------- |
David de Lignon
(Division Sign-Off) Division of Reproductive. Abdominal and Padiplogical Devices 5 Hilk) Number ______
Prescription Use (Per 21 CFR 801.109)
16
การเลื้อสร้างอิง me gy : Z | 90-61-380
{17}------------------------------------------------
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM 00€ NOTSION 900
System : Transducer:
EUF-850
Clinical Application Mode of Operation General Specific B PWD M CWD Color Combined Other ** (Tracks I & II) (Track I only) Doppler (Spec.) (Spec.) Ophthalmic Ophthalmic Fetal p ម ਨ p P P P Abdominal Pa Pa ਿੰਡ । ਇਥ । । ए Pa Pa Intra operative (Spec.) Intra-operative (Neuro.) Laparoscopic Pediatric P P b P F P P Small Organ (Spec.) Neonatal Cephalic Fotal Imaging Adult Cephalic b P P P P P P & Other Trans rects] Trans-vaginal Trans-urethral Trana esoph, (non-Card.) Musculo skel. (Convent.) Musculo-skel. (Superfic.) Intra-luminal Other (spec.) Cardiac Adult P p Cardiac Cardiac Pediatric P P ાં ર P P P P Trans-esophageal (card.) Other (spec.) Peripheral Peripheral vessel P P P Б Б P P Other (spec.) Vessel
Intended use. Diagnostic ultrasound imaging or thuid flow analysis if the human body as follows'
N = new indication. P = previous indication
*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. |
CONTRE BETOW 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: K063518
David R. Ingram
of Renroniciu
Prescription Use (Per 21 CFR 801.109)
ില്ലേഷ 020/710.9 £80-1
6470896000114
siiromA smatzy2 lesibeM idisetiH-mo13
me gr : 7 |
{18}------------------------------------------------
System : Transdu
| HI VISION 900 | |
|---|---|
| ucer: | EUP-TC3 |
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other **(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra operative (Spec.) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Spec.) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | Adult Cephalic | ||||||||
| & Other | Trans-rectal | ||||||||
| Trans vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel (Convent.) | |||||||||
| Musculo skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | P | ||||||||
| Cardiac | Cardiac Pediatric | P | |||||||
| Trans esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | Peripheral vessel | P | |||||||
| Vessel | Other (spec.) |
Intended use : Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
N = new indication, P = previous indication
*No combination modes
""No other modes
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) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number: K063518
David R. Segerson
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109)
{19}------------------------------------------------
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM 00€ NOISIN H
Transducer EUP-U533
System'
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | Ph | Ph | Ph | Ph | Ph | Ph | ||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.)Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vesselOther (spec.) |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
N = new indication, P = previous indication
- Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler and Harmonic Imaging.
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocontesis). Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). Subscript "c": Includes thyroid, parathyroid, breast, scrotum, ponis. Subscript "d": Includes thyroid, parathyroid, breast, scrotum, panis and imaging for guidance of biopsy. Subscript "c": Includes imaging for guidance of transrectal biopay. Subscript "I": Includes imaging for guidance of transvaginal biopsy. Subacript "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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number: 15063518
David A. Segerson
(Division Sian-Off on of Reproductive, Abdomin frompral Devices
Prescription Usis (Per 21 CFR 801.109)
168-1 020/810.9 180-1 647069698988888
storema smatzva sveticel systems approvise
90-61-380
12.44.488
{20}------------------------------------------------
System : Transducer: EUP-V53W
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| Ophthalmi: | Ophthalmic | P | P | P | P | P | P | |
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | Pe | Pe | Pe | Pe | Pe | Pe | ||
| Trans-vaginal | Pf | Pf | Pf | Pf | Pf | Pf | ||
| Trans urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows
N = new indication, P = previous indication
- Combination of each operating mode, B, M, PWD 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) |
Concurrence of CDRH. Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number: K063518
Daniel A. Seegman
20
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K063518
Prescription Us: (Per 21 CFR 801.109)
§ 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.