(23 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ (Thyroid, Breast and Testicles), Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal and Pediatric.
The 7300 is a compact ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes, Tissuc Enhancement Imaging (TEI). The 7300 is equipped with an LCD Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations. The 7300 can drive phased (PA), convex (CA) and linear array (1.A) probes. The 7300 is equipped with a CD-RW disk drive that can be used for image storage. Data can also be stored directly to a Personal Computer via a LAN port. Optional accessory devices available for the 7300 include an S-VHS video recorder; a monochrome or color page printer and a mobile trolley equipped with an isolation transformer.
This document is a 510(k) Summary for the 7300 Ultrasound Imaging System. It describes the device's characteristics and intended uses, and asserts its substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:
-
A table of acceptance criteria and the reported device performance:
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for image quality or diagnostic capabilities. Instead, it demonstrates acceptance primarily through substantial equivalence to predicate devices. The "reported device performance" is implicitly that the 7300 Ultrasound Imaging System meets the same safety and effectiveness standards as the predicate devices for its stated intended uses and technological characteristics.
The table provided in the document focuses on technological characteristics and intended uses to demonstrate equivalence to the predicate "Megas (K982444 & 994369)".
Characteristic 7300 (This submission) Megas (K982444 & 994369) Electrical Safety IEC60601-1 IEC60601-1 Ultrasound Safety Track 3 (Acoustic Output Display) Track 3 (Acoustic Output Display) Indication for Use • Cardiac YES YES • Transesophageal YES YES • Peripheral Vascular YES YES • Neonatal Cephalic YES YES • Adult Cephalic YES YES • Small organ YES YES • Musculoskeletal (conventional & superficial) YES NO (This is a new indication for the 7300 compared to Megas) • Abdominal YES YES • OB/Fetal YES YES • Transvaginal YES YES • Transrectal YES YES • Pediatric YES YES Probe Technology • Annular Array NO YES • Phased Array YES YES • Linear array YES YES • Convex Array YES YES Modes of operation 2D, M-Mode, PW, CW, CFM, Amplitude Doppler, TEI 2D, M-Mode, PW, CW, CFM, Amplitude Doppler, TEI Imaging Frequencies 2.0,2.5, 3.5, 5.0, 7.5, 10 MHz 2.0,2.5, 3.5, 5.0, 7.5, 10 MHz CFM/Doppler Frequencies 2.0, 2.5, 3.3, 5.0 MHz 2.0, 2.5, 3.3, 5.0 MHz Tissue Velocity Mapping feature YES NO (This is a new feature for the 7300) Biopsy Guidance YES YES • Biopsy Intended Uses General Purpose, Transrectal, Transvaginal General Purpose, Transrectal, Transvaginal • Biopsy Line Depth marker 1 cm 1 cm Needle Guide Angle ABS421: 20° 30°, ABS523: 45°, ABS123: 3.8° ABS421: 20° 30°, ABS523: 45°, ABS123: 3.8° Display Type SVGA SVGA Digital Archival Capabilities YES YES DICOM Classes YES (Media Storage, Storage SCU) YES VCR / Page Printer YES YES M&A Capabilities Cardiac, Vascular, OB and general purpose measurements Cardiac, Vascular, OB and general purpose measurements Weight 10 kg 25 kg Dimensions portable: 35.5 (w) x 14 (h) x 49 (d) cm; use: 35.5 (w) x 41 (h) x 49 (d) cm portable: 46 (w) x 23.5 (h) x 55 (d) cm; use: 46 (w) x 23.5 (h) x 68 (d) cm The acceptance criterion is that the 7300 Ultrasound Imaging System is substantially equivalent to the predicate devices (Esaote, S.p.A. 7250 Ultrasound Imaging System K982444, K004360, K994369, and Technos Ultrasound Imaging System K014168, and Philips Medical Systems M2540 Ultrasound System K014199) in terms of intended use, technological characteristics, and safety/effectiveness. The table above serves to demonstrate this equivalence by comparing features.
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The 510(k) summary does not describe a specific clinical test set, sample size, or data provenance for proving the device's performance in a diagnostic capacity. The clearance hinges on substantial equivalence, which primarily involves comparing the device's technical specifications and intended uses to those of legally marketed predicate devices. The FDA letter mentions a requirement for a "postclearance special report" to be submitted prior to shipping the first device, which should contain "complete information, including acoustic output measurements based on production line devices." This suggests that performance testing related to acoustic output would be done post-clearance on production units, not as part of a pre-market test set.
-
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 applicable as the document does not describe a clinical study involving a test set and ground truth established by experts.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable for the same reason as point 3.
-
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 information is not applicable. The 7300 Ultrasound Imaging System is a diagnostic imaging device, not an AI-assisted interpretation tool. The document does not describe any MRMC study or AI components.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is an ultrasound imaging system, not a standalone algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable as the document does not describe a clinical test set requiring a ground truth. The basis for clearance is technical comparison and safety standards adherence.
-
The sample size for the training set:
This information is not applicable as the device is not an AI/ML algorithm that requires a training set.
-
How the ground truth for the training set was established:
This information is not applicable as the device is not an AI/ML algorithm that requires a training set and ground truth.
Summary of Study that Proves Device Meets Acceptance Criteria:
The "study" proving the device meets acceptance criteria is primarily a comparative analysis of technical characteristics and intended uses against legally marketed predicate devices. The acceptance criteria are essentially that the 7300 Ultrasound Imaging System is substantially equivalent to the predicate devices in terms of safety and effectiveness, based on adherence to recognized safety standards (IEC60601-1, Track 3 Acoustic Output Display) and comparable technological features and clinical indications. The document asserts that the differences in technological characteristics (e.g., Musculoskeletal indication, Tissue Enhancement Imaging, absence of Annular Array, and changes in physical dimensions) do not raise new questions of safety or effectiveness. The FDA's issuance of the 510(k) clearance letter (K040596) signifies their agreement with this assessment of substantial equivalence.
{0}------------------------------------------------
KD.4 D596
510(k) Summary 7300 Ultrasound Imaging System Esaote, S.p.A.
MAR 3 1 2004
510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR¶807.92(a).
807.92(a)(1)
Submitter Information
Colleen Densmore, Official Correspondent The Anson Group 7992 Castleway Drive Indianapolis, Indiana 46250 Phone: (317) 849-1916 Facsimile: (317) 577-9070
| Contact Person: | Carri Graham | |
|---|---|---|
| Date: | February 20, 2004 | |
| 807.92(a)(2) | ||
| Trade Name: | 7300 Ultrasound Imaging System | |
| Common Name: | Ultrasound Imaging System | |
| Classification Name(s): | Ultrasonic pulse doppler imaging system 892.1550Ultrasonic pulsed echo imaging system 892.1560 | |
| Classification Number: | 90IYN; 90IYO | |
| 807.92(a)(3) | Predicate Device(s) | |
| Esaote, S.p.A. | 7250 Ultrasound ImagingSystem | K982444 |
| Esaote, S.p.A. | 7250 Ultrasound ImagingSystem | K004360 |
| Esaote, S.p.A. | 7250 Ultrasound ImagingSystem | K994369 |
|---|---|---|
| Esaote, S.p.A. | Technos UltrasoundImaging System | K014168 |
| Philips Medical Systems | M2540 Ultrasound System | K014199 |
{1}------------------------------------------------
510(k) Summary 7300 Ultrasound Imaging System Esaole, S.p.A.
807.92 (a)(4)
Device Description
The 7300 is a compact ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes, Tissuc Enhancement Imaging (TEI). The 7300 is equipped with an LCD Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations. The 7300 can drive phased (PA), convex (CA) and linear array (1.A) probes. The 7300 is equipped with a CD-RW disk drive that can be used for image storage. Data can also be stored directly to a Personal Computer via a LAN port. Optional accessory devices available for the 7300 include an S-VHS video recorder; a monochrome or color page printer and a mobile trolley equipped with an isolation transformer.
807.92(a)(5)
Intended Use(s)
Esaote's Model 7300 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal and Pediatric.
{2}------------------------------------------------
510(k) Summary 7300 Ultrasound Imaging System
Esaote, S.p.A. 807.92(a)(6)
Technological Characteristics
| Technological Characteristics7300 (This submission) | Megas (K982444 & 994369) | |
|---|---|---|
| Electrical Safety | IEC60601-1 | IEC60601-1 |
| Ultrasound Safety | Track 3 (Acoustic Output Display) | Track 3 (Acoustic Output Display) |
| Indication for Use | ||
| • Cardiac | YES | YES |
| • Transesophageal | YES | YES |
| • Peripheral Vascular | YES | YES |
| • Neonatal Cephalic | YES | YES |
| • Adult Cephalic | YES | YES |
| • Small organ | YES | YES |
| • Musculoskeletal (conventional& superficial) | YES | NO |
| • Abdominal | YES | YES |
| • OB/Fetal | YES | YES |
| • Transvaginal | YES | YES |
| • Transrectal | YES | YES |
| • Pediatric | YES | YES |
| Probe Technology | ||
| • Annular Array | NO | YES |
| • Phased Array | YES | YES |
| • Linear array | YES | YES |
| • Convex Array | YES | YES |
| Modes of operation | 2D, M-Mode, PW, CW, CFM,Amplitude Doppler, TEI | 2D, M-Mode, PW, CW, CFM,Amplitude Doppler, TEI |
| Imaging Frequencies | 2.0,2.5, 3.5, 5.0, 7.5, 10 MHz | 2.0,2.5, 3.5, 5.0, 7.5, 10 MHz |
| CFM/Doppler Frequencies | 2.0, 2.5, 3.3, 5.0 MHz | 2.0, 2.5, 3.3, 5.0 MHz |
| Tissue Velocity Mapping feature | YES | NO |
| Biopsy Guidance | YES | YES |
| • Biopsy Intended Uses | General Purpose, Transrectal,Transvaginal | General Purpose, Transrectal,Transvaginal |
| • Biopsy Line Depth marker | 1 cm | 1 cm |
| Needle Guide Angle | ABS421: 20° 30°ABS523: 45°ABS123: 3.8° | ABS421: 20° 30°ABS523: 45°ABS123: 3.8° |
| Display Type | SVGA | SVGA |
| Digital Archival Capabilities | YES | YES |
| DICOM Classes: | YES | YES |
| Media Storage, Storage SCU | ||
| VCR / Page Printer | YES | YES |
| M&A Capabilities | Cardiac, Vascular, OB and generalpurpose measurements | Cardiac, Vascular, OB and generalpurpose measurements |
| Weight | 10 kg | 25 kg |
| Dimensions | portable position:35.5 (w) x 14 (h) x 49 (d) cmuse position: | portable position:46 (w) x 23.5 (h) x 55 (d) cmuse position: |
| 35.5 (w) x 41 (h) x 49 (d) cm | 46 (w) x 23.5 (h) x 68 (d) cm |
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized, curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 2004
Esaote, S.p.A. % Ms. Carri Graham The Anson Group, LLC 7992 Castleway Drive INDIANAPOLIS IN 46250
Re: K040596
Trade Name: 7300 Ultrasound Imaging System 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: 90 IYN, IYO. and ITX Dated: March 5, 2004 Received: March 8, 2004
Dear Ms. Graham:
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 7300 Ultrasound Imaging System, as described in your premarket notification:
Transducer Model Number
| PA230E |
|---|
| PA122E |
| LA523 |
| CA421 |
{4}------------------------------------------------
EC123 TE022
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
{5}------------------------------------------------
Page 3 – Ms. Graham
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David A. Lygum
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
{6}------------------------------------------------
Mod.7300
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other (specify)TEI (3) |
| Ophthalmic | ||||||||||
| Fetal | N | N | N | N | N | N [2] | N | |||
| Abdominal | N | N | N | N | N | N [2] | N | |||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | N | N | N | N | N | N | N [2] | N | ||
| Small Organ (specify) [1] | N | N | N | N | N | N | N [2] | |||
| Neonatal Cephalic | N | N | N | N | N | N | N [2] | |||
| Adult Cephalic | N | N | N | N | N | N | N [2] | |||
| Cardiac | N | N | N | N | N | N | N [2] | N | ||
| Transesophageal | N | N | N | N | N | N [2] | ||||
| Transrectal | N | N | N | N | N | N [2] | ||||
| Transvaginal | N | N | N | N | N | N [2] | ||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N [2] | |||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | N | N | N | N | N | N | N [2] | |||
| Musculo-skeletal Superficial | N | N | N | N | N | N | N [2] | |||
| Other (specify) |
N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:
[1] Small organs include Thyroid, Breast and Testicles.
- [2] Applicable combined modes: B+M+PW+CW+CFM+PD
- [3] Tissue Enhancement Imaging (TEI)
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED
concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lymm
510k)
{7}------------------------------------------------
Transducer: PA230E
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Mode of Operation | ||||||||||
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other (specify)TEI (2) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | N | N | N | N | N | N | N | N[1] | ||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | N | N | N | N | N | N | N | N[1] | ||
| Cardiac | N | N | N | N | N | N | N | N[1] | N | |
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculoskeletal Superficial | ||||||||||
| Other (specify) |
N=new indication; P=previously cleared by FDA; E= added under Appendix E
Additional Comments:
[1] Applicable combined modes: B+M+PW+CW+CFM+PD
[2] Tissue Enhancement Imaging (TEI)
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED
concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lyman
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
{8}------------------------------------------------
Transducer: PA122E
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows. | ||
|---|---|---|
| -------------------------------------------------------------------------------------------------- | -- | -- |
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | N | N | N | N | N | N | N[1] | |||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N[1] | |||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | N | N | N | N[1] | |||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N[1] | |||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:
[1] Applicable combined modes: B+M+PW+CW+CFM+PD
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED
concurrence of CDRH. Office of Device Evaluation (ODE)
David Oh. Lyman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
{9}------------------------------------------------
Transducer: LA523
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||
|---|---|---|---|---|
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other (specify) | |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | N | N | N | N | N | N[2] | ||||
| Small Organ (specify) [1] | N | N | N | N | N | N[2] | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | N | N | N | N[2] | ||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | N | N | N | N | N | N[2] | ||||
| Musculo-skeletal Superficial | N | N | N | N | N | N[2] | ||||
| Other (specify) |
N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:
[1] Small organs include Thyroid, Breast and Testicles.
{2} Applicable combined modes: B+M+PW+CW+CFM+PD
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED
concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Byrom
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
{10}------------------------------------------------
Transducer: CA421
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other (specify)TEI (2) |
| Ophthalmic | ||||||||||
| Fetal | N | N | N | N | N | N[1] | N | |||
| Abdominal | N | N | N | N | N | N[1] | N | |||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | N | N | N | N | N | N[1] | N | |||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:
[1] Applicable combined modes: B+M+PW+CFM+PD.
[2] Tissue Enhancement Imaging (TEI)
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED
concurrence of CDRH, Office of Device Evaluation (ODE)
David bh. Sezman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
{11}------------------------------------------------
Transducer: EC123
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | N | N | N | N | N | N[1] | ||||
| Transvaginal | N | N | N | N | N | N[1] | ||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculoskeletal Superficial | ||||||||||
| Other (specify) |
N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:
[1] Applicable combined modes: B+M+PW+CFM+PD.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED
concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lynn
(Division S gn-Off) Division of Reproductive, Abdominal. and Radiological Dev
510(k) Number K040596
{12}------------------------------------------------
Transducer: TE022
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | N | N | N | N | N | N[1] | ||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculoskeletal Superficial | ||||||||||
| Other (specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:
{ l ] Applicable combined modes: B+M+PW++CW+CFM+PD
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED
concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lawson
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number.
§ 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.