(19 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal and Pediatric.
The 7350 is a mainframe ultrasound system used to perform diagnostic general The 7500 is a first framimary modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes, Tissue Enhancement Imaging (TEI). The 7350 is equipped with a CRT Color Display. The full alphanumeric keyboard (1121). The plete on-screen data entry of patient information and on-screen annotations. The 7350 can drive phased (PA), convex (CA) and linear array (LA) probes. The 7350 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 7350 include an S-VHS video recorder; a monochrome or color page printer. The 7350 is equipped with an isolation transformer to adequately insulate the system's peripherals.
Here's an analysis of the acceptance criteria and study information for the Esaote 7350 Ultrasound Imaging System (K050326), based on the provided 510(k) summary:
This 510(k) summary focuses on establishing substantial equivalence to predicate devices rather than providing detailed clinical study results with specific performance metrics and acceptance criteria in the way a novel AI/CADe device submission might. Therefore, many of the requested fields will be marked as "Not Applicable" or "Not Provided" based on the content. The acceptance criteria here largely refer to meeting the same technological characteristics and intended uses as the predicate devices, and demonstrating safety and effectiveness as an ultrasound imaging system.
Acceptance Criteria and Device Performance for Esaote 7350 Ultrasound Imaging System (K050326)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on predicate device characteristics and safety standards) | Reported Device Performance (Esaote 7350) |
|---|---|
| Electrical Safety: Compliance with IEC60601-1 | Complies with IEC60601-1 |
| Ultrasound Safety: Track 3 (Acoustic Output Display) | Track 3 (Acoustic Output Display) |
| Intended Use Equivalence: Covers specified clinical applications | Covers all specified clinical applications (Cardiac, Fetal, Abdominal, Pediatric, etc.) |
| (See detailed list of "new indications" and previously cleared indications in the document) | |
| Probe Technology Equivalence: Supports Phased Array, Linear Array, Convex Array | Supports Phased Array, Linear Array, Convex Array |
| Operating Modes Equivalence: Supports 2D, M-Mode, PW, CW, CFM, Amplitude Doppler, TEI | Supports 2D, M-Mode, PW, CW, CFM, Amplitude Doppler, TEI |
| Imaging Frequencies Equivalence: Supports 2.0-10 MHz | Supports 2.0, 2.5, 3.5, 5.0, 7.5, 10 MHz |
| CFM/Doppler Frequencies Equivalence: Supports specified range | Supports 2.0, 2.5, 3.3, 5.0, 6.6, 8.0 MHz (broader than some predicates) |
| Tissue Velocity Mapping feature: If present in predicate, expected here | YES (present, similar to 7300, but not Megas) |
| Biopsy Guidance Equivalence: Supports specified uses and markers | Supports General Purpose, Transrectal, Transvaginal with 1 cm line depth marker |
| Display Characteristics Equivalence: SVGA standard | SVGA standard (uses CRT vs. LCD on 7300, but still SVGA) |
| Digital Archival Capabilities: YES | YES (CD-RW, LAN port, DICOM classes) |
| VCR / Page Printer Support: YES | YES |
| M&A Capabilities Equivalence: Cardiac, Vascular, OB, general purpose | Cardiac, Vascular, OB, general purpose measurements |
2. Sample Size Used for the Test Set and Data Provenance
The provided document is a 510(k) summary for an ultrasound imaging system. It primarily establishes substantial equivalence based on technical specifications and intended uses compared to predicate devices. It does not contain information about a clinical test set with patient data (images) in the way that an AI/CADe device submission would. The "performance" assessment here relates to the system's ability to operate according to its specifications and perform the listed imaging modes for various clinical applications, which is typically verified through engineering testing, compliance with standards, and comparison to existing cleared devices.
Therefore:
- Sample Size for Test Set: Not applicable or not provided. This type of device typically undergoes extensive bench testing, phantom studies, and possibly limited clinical evaluations for image quality and functionality, but not a "test set" of patient data for diagnostic accuracy in the context of AI.
- Data Provenance (Country of Origin, Retrospective/Prospective): Not applicable or not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The "ground truth" for an ultrasound system of this nature is its ability to produce diagnostically acceptable images for various applications and its compliance with safety and performance standards. This is assessed through technical verification and validation, not by expert interpretation of a specific test set.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no mention of an adjudication process for a test set of images.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This is a submission for a general ultrasound imaging system, not an AI/CADe tool, so an MRMC study comparing human readers with and without AI assistance is not relevant or expected for this type of device.
- Effect size of human readers improving with AI vs without AI assistance: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: Not applicable. This device is an imaging system, not an algorithm, so the concept of standalone performance does not apply.
7. The Type of Ground Truth Used
- Type of Ground Truth: For this type of device, the "ground truth" is derived from:
- Technical Specifications and Standards Compliance: Meeting electromagnetic compatibility, acoustic output limits (IEC60601-1, Track 3 Acoustic Output Display), and electrical safety standards.
- Predicate Device Equivalence: Demonstrating that the new device has substantially equivalent technological characteristics and intended uses to previously cleared (predicate) ultrasound systems.
- Image Quality Assessment: Verification that the system produces images of diagnostic quality across its intended applications and modes, likely through phantom studies and internal clinical evaluation by ultrasound specialists, but without a formal external "ground truth" per se in the context of a diagnostic accuracy study.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/CADe device that relies on a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established (for Training Set): Not applicable.
{0}------------------------------------------------
510(k) Summary 7350 Ultrasound Imaging System Esaote. S.p.A.
FEB 2 8 2005 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
Carri Graham, Official Correspondent The Anson Group 7992 Castleway Drive Indianapolis, Indiana 46250 Phone: (317) 849-1916 x103 Facsimile: (317) 577-9070
Esaote, S.p.A.
| Contact Person: | Carri Graham |
|---|---|
| Date: | February 4, 2005 |
807.92(a)(2)
| Trade Name: | 7350 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 Imaging System | K982444 |
|---|---|---|
| Esaote, S.p.A. | 7250 Ultrasound Imaging System | K994369 |
| Esaote, S.p.A. | 7300 Ultrasound Imaging System | K040596 |
System
{1}------------------------------------------------
510(k) Summary 7350 Ultrasound Imaging System Esaote, S.p.A.
807.92 (a)(4)
Device Description
The 7350 is a mainframe ultrasound system used to perform diagnostic general The 7500 is a first framimary modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes, Tissue Enhancement Imaging (TEI). The 7350 is equipped with a CRT Color Display. The full alphanumeric keyboard (1121). The plete on-screen data entry of patient information and on-screen annotations. The 7350 can drive phased (PA), convex (CA) and linear array (LA) probes. The 7350 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 7350 include an S-VHS video recorder; a monochrome or color page printer. The 7350 is equipped with an isolation transformer to adequately insulate the system's peripherals.
807.92(a)(5)
Intended Use(s)
Esaote's Model 7350 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal and Pediatric.
{2}------------------------------------------------
807.92(a)(6)
Technological Characteristics
| 7350 (This submission) | 7300 (K040596) | Megas (K982444 & 994369) | |
|---|---|---|---|
| IEC60601-1 | IEC60601-1 | IEC60601-1 | |
| Electrical SafetyUltrasound Safety | Track 3 (Acoustic Output Display) | Track 3 (Acoustic Output Display) | Track 3 (Acoustic Output Display) |
| Indication for Use | |||
| • Cardiac | YES | YES | YES |
| • Transesophageal | YES | YES | YES |
| • Peripheral Vascular | YES | YES | YES |
| • Neonatal Cephalic | YES | YES | YES |
| • Adult Cephalic | YES | YES | YES |
| • Small organ | YES | YES | NO |
| • Musculoskeletal (conventional & superficial) | YES | YES | NO |
| • Abdominal | YES | YES | YES |
| • OB/Fetal | YES | YES | YES |
| • Transvaginal | YES | YES | YES |
| • Transrectal | YES | YES | YES |
| • Pediatric | YES | YES | YES |
| Probe Technology | |||
| • Phased Array | YES | YES | YES |
| • Linear Array | YES | YES | YES |
| • Convex Array | YES | YES | YES |
| Doppler Probes | |||
| Modes of operation | 2D, M-Mode, PW, CW, CFM, Amplitude Doppler, TEI | 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 | 2.0,2.5, 3.5, 5.0, 7.5, 10 MHz |
| CFM/Doppler Frequencies | 2.0, 2.5, 3.3, 5.0, 6.6, 8.0 MHz | 2.0, 2.5, 3.3, 5.0, 6.6 MHz | 2.0, 2.5, 3.3, 5.0 MHz |
| Tissue Velocity Mapping feature | YES | YES | NO |
| Biopsy Guidance | |||
| Biopsy Intended Uses | General Purpose, Transrectal, Transvaginal | General Purpose, Transrectal, Transvaginal | General Purpose, Transrectal, Transvaginal |
| Biopsy Line Depth marker | 1 cm | 1 cm | 1 cm |
| Needle Guide Angle | ABS421: 20° 30°ABS523: 45°ABS123: 3.8° | ABS421: 20° 30°ABS523: 45°ABS123: 3.8° | ABS421: 20° 30°ABS523: 45°ABS123: 3.8° |
| 7350 (This submission) | 7300 (K040596) | Megas (K982444 & 994369) | |
| ABS621: 25° 35° | ABS621: 25° 35° | ABS621: 25° 35° | |
| Display type | CRT | LCD | LCD or CRT (optional) |
| Display Standard | SVGA | SVGA | SVGA |
| Digital Archival Capabilities | YES | YES | YES |
| DICOM Classes:Media Storage, StorageSCU | YES | YES | YES |
| VCR / Page Printer | YES | YES | YES |
| M&A Capabilities | Cardiac, Vascular, OB andgeneral purpose measurements | Cardiac, Vascular, OB andgeneral purpose measurements | Cardiac, Vascular, OB andgeneral purpose measurements |
| Weight | 90 kg | portable: 10 kgwith trolley: 40 kg | 25 kg |
| Dimensions | 60(w) x 155(h) x 90(d) cm | portable position:35.5 (w) x 14 (h) x 49 (d) cmuse position:35.5 (w) x 41 (h) x 49 (d) cmwith trolley:50 (w) x 130 (h) x 51 (d) cm | portable position:46 (w) x 23.5 (h) x 55 (d) cmuse position:46 (w) x 23.5 (h) x 68 (d) cm |
{3}------------------------------------------------
{4}------------------------------------------------
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
FEB 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Esaote S.p.A. % Ms. Carri Graham The Anson Group 7992 Castleway Drive INDIANAPLOIS IN 46250
Re: K050326
Trade Name: 7350 Ultrasound Imaging System (or MyLab50) 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: February 4, 2005 Received: February 9, 2005
Dear Ms. Graham:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because ermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use sutted in also 28, 1976, the enactment date of the Medical Device interstate continetee pror to May 20, 1978, extensified in accordance with the provisions of the Allentallents, of to devices marilate of Act (Act). You may, therefore, market the device, subject to Federal Food, Drug, and Oosmette Fee et. The general controls provisions of the Act include the general Controls of the Frein of the Press, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for This determination of substantial equil as a may be and the may be and in your premarket notification:
Transducer Model Number
| PA230 | PA023 |
|---|---|
| PA121 | LA522 |
| PA122 | LA532 |
{5}------------------------------------------------
Page 2 -- Ms. Graham
| LA523 | CA123 |
|---|---|
| LA424 | 2.0 CW |
| CA421 | 5.0 CW |
| CA430 | EC123 |
| CA621 | TEE02 |
ff your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (See above) into ontrols. Existing major regulations affecting your device FDA it may be subject to such additional controls: "Darts 800 to 898. In addition, FDA
can be found in the Code of Federal Regulations, Title Rederal Register can be found in the Code of I cacral Regalations, and device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA $ issualled of a substition with other requirements of the Act
that FDA has made a determination that your device on answeries - You must that FDA has made a decemination all. Jour areas by other Federal agencies. You must or any Federal statutes and regulations daministered by registration and listing (21
comply with all the Act's requirements, including, but not limited to set comply with an the Act s requirements, me, good manufacturing practice requirements as setter CFR Part 807), labeling (21 CFR Part 800); good analifan (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping as males I his determination of Substance special report. This report should complete the first device, you submit a postereditation special in production line devices, requested information, including acousine output measarements 30, 1997 "Information for Manufacturers
in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manu in Appendix CT, (enclosed) of the Center of Systems and Transducers." If the special Seeking Marketing Clearance of Diagnostic or allues (e.g., acoustic output greater than approved report is incomplete of contains anacepat of 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 The special report should be submitted in duplicated in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket This letter will anow you to ocgin manoling 5 wavalence of your device to a legally marketed notification. The I D71 miding of caseliantal varyour 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 If you desire specific advice in Joan as (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Comphalled at (11 notification" (21CFR Part 807.97). You may obtain MISDrailding by ICICICleC to promatics nowledged on the Act from the Division of Small
{6}------------------------------------------------
Page 2 – Ms. Graham
Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Collisantes are worked with insmaldsmamain.html
(301) 443-6597 or at its Internet address http://www.fass.contact Rodrigo C. (301) 443-6597 or at its Internet address mtp.7.www.ida.goveding and action of Rodrigo C. Perez at
If you have any questions regarding the content of this letter, please cont (301) 594-1212.
Sincerely yours,
Qurilla depris...
f..
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{7}------------------------------------------------
Mod.7350
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 | N | N | N | N | N | N [1] | N [3] | |||
| Abdominal | N | N | N | N | N | N [1] | N [3] | |||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | N | N | N | N | N | N | N [1] | N [3] | ||
| Small Organ (specify) [2] | N | N | N | N | N | N | N [1] | N [3] | ||
| Neonatal Cephalic | N | N | N | N | N | N | N [1] | |||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | N | N | N [1] | N [3] | |||
| Transesophageal | N | N | N | N | N | N [1] | ||||
| Transrectal | N | N | N | N | N | N [1] | ||||
| Transvaginal | N | N | N | N | N | N [1] | ||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N [1] | |||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | N | N | N | N | N | N | N [1] | |||
| Musculo-skeletal Superficial | N | N | N | N | N | N | N [1] | |||
| 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] Small organs include Thyroid, Breast and Testicles.
[3] Tissue Harmonic Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED
concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Lippman
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
{8}------------------------------------------------
Transducer: PA230
| 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 | N | N | N | N | N | N | N [1] | ||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | N | N | N | N | N | N | N [1] | N [3] | |||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculoskeletal Superficial | |||||||||||
| Other (specify) | |||||||||||
| Clinical Application | A | B | M | PWD (PW) | CWD | Color Doppler (CFM) | Amplitude Doppler (PD) | Color Velocity Imaging | Combined (specify) | Other (specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | N | N | N | N | N | N [1] | N [3] | ||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | N [1] | N [3] | |||||||||
| Cardiac | N | N | N | N | N | N | N [1] | N [3] | |||
| Tranesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other (specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | N[1] | ||||||||||
| Pediatric | N | N | N | N | N | N | |||||
| Small Organ (specify) | N[1] | ||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | |||||
| Adult Cephalic | N[1] | ||||||||||
| Cardiac | N | N | N | N | N | ||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | N[1] | ||||||||||
| Peripheral Vascular | N | N | N | N | N | N | |||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) | |||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD(PW) | CWD | ColorDoppler(CFM) | AmplitudeDoppler(PD) | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative(specify) | |||||||||||
| IntraoperativeNeurological | N | N | N | N | N | N | N [1] | ||||
| Pediatric | |||||||||||
| Small Organ(specify) | |||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N [1] | ||||
| Adult Cephalic | |||||||||||
| Cardiac | N | N | N | N | N | N [1] | |||||
| Tranesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| PeripheralVascular | N | N | N | N | N | N | N [1] | ||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD(PW) | CWD | ColorDoppler(CFM) | AmplitudeDoppler(PD) | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative(specify) | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | N | N | N | N | N | N [1] | |||||
| Small Organ(specify) [2] | N | N | N | N | N | N [1] | |||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Tranesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| PeripheralVascular | N | N | N | N | N | N [1] | |||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD(PW) | CWD | ColorDoppler(CFM) | AmplitudeDoppler(PD) | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative(specify) | |||||||||||
| IntraoperativeNeurological | N [1] | ||||||||||
| Pediatric | N | N | N | N | N | N | N [1] | N [3] | |||
| Small Organ(specify) [2] | N | N | N | N | N | N | N [1] | N [3] | |||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Tranesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| PeripheralVascular | N | N | N | N | N | N | N [1] | N [3] | |||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial |
of the human body as follows: . . . . ﺎ.
N=new indication; P=previously cleared by FDA; E= added under Appendix E
Additional Comments:
al Comments:
[1] Applicable combined modes: B+M+PW+CW+CFM+PD
- [3] Tissue Harmonic Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED
concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel G. Legum
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
{9}------------------------------------------------
Appendix F
PA121
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each uitrasound system and each transducer.
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:
Additional Comments:
[1] Applicable combined modes: B+PW+CFM+M+PD
[3] Tissue Harmonic Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON
Darice Subluation (ODF)Concurrence of CDRH, Office of Device
i Prescription Use
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K050326 |
18
ron D
FROED)
{10}------------------------------------------------
Transducer: PA122
fluid flow analysis of the human body as follows:
Since (1) == lication; P=previously cleared by FDA; E= added under Appendix E
Additional Comments:
nal Comments:
{ } } Applicable combined modes: B+M+PW+CW+CFM+PD
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PACE IF NEEDED
concurrence of CDRH, Office of Device Evaluation (ODE)
Darold h. Kyper
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
{11}------------------------------------------------
Appendix F
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
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:
Additional Comments.
[1] Applicable combined modes: B+PW+CFM+M+PD
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Concurrence of CDRH, Office of Device Evalua
C. PRESCRIPTION FILE
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
20
K050326
{12}------------------------------------------------
Appendix F
LA522
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
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:
Additional Comments.
[1] Applicable combined modes: B+PW+CFM+M+PD
[ ] Applicable combined sally, thyroid, testicles, and breast)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
ALY
Concurrence of CDRH, Office of Device Evaluation (ODE) 11
Description: L
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K050326
21
{13}------------------------------------------------
AppendixF
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
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:
Additional Comments:
[1] Applicable combined modes: B+PW+CFM+M+PD
[ I ] Applicable contomed modes. thouse. " thyroid, testicles, and breast);
[3] Tissue Harmonic Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kand G. Lyman
Division Sign Off
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K05030
{14}------------------------------------------------
Transducer: LA523
| 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[1] | ||||
| Small Organ (specify) [2] | N | N | N | N | N | N[1] | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | N | N | N | N[1] | ||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | N | N | N | N | N | N[1] | ||||
| Musculo-skeletal Superficial | N | N | N | N | N | N[1] | ||||
| Other (specify) |
aging 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+CW+CFM+PD
[1] Applicable Somelude Thyroid, Breast and Testicles.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED
concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Symon
(Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devices ං ! `ik) Number _____________________________________________________________________________________________________________________________________________________________
{15}------------------------------------------------
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD(PW) | CWD | ColorDoppler(CFM) | AmplitudeDoppler(PD) | ColorVelocityImaging | Combined(specify) | Other(specify) | ||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative(specify) | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | N | N | N | N | N | N [1] | |||||
| Small Organ(specify) [2] | N | N | N | N | N | N [1] | |||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Tranesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| PeripheralVascular | N | N | N | N | N | N [1] | |||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | N | N | N | N | N | N [1] | |||||
| Musculo-skeletalSuperficial | N | N | N | N | N | N [1] | |||||
| Other | |||||||||||
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other (specify) | |
| Ophthalmic | |||||||||||
| Fetal | N | N | N | N | N | N[1] | N[3] | ||||
| Abdominal | N | N | N | N | N | N[1] | N[3] | ||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | N | N | N | N | N | N[1] | N[3] | ||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | N | N | N | N | N | N[1] | N[3] | ||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) | |||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD(PW) | CWD | ColorDoppler(CFM) | AmplitudeDoppler(PD) | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | N | N [1] | |||||||||
| Fetal | N | N | N | N | N | N | N [1] | N [3] | |||
| Abdominal | N | N | N | N | N | N | N | N [1] | |||
| Intraoperative(specify) | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ(specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Tranesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | N [1] | ||||||||||
| PeripheralVascular | N | N | N | N | N | N | |||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD(PW) | CWD | ColorDoppler(CFM) | AmplitudeDoppler(PD) | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | |||||||||||
| Fetal | N | N | N | N | N | N [1] | N [3] | ||||
| Abdominal | N | N | N | N | N | N [1] | N [3] | ||||
| Intraoperative(specify) | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ(specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| PeripheralVascular | N | N | N | N | N | N [1] | N [3] | ||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD(PW) | CWD | ColorDoppler(CFM) | AmplitudeDoppler(PD) | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative(specify) | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | N | N | N | N | N | N | N [1] | ||||
| Small Organ(specify) (2) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | N | N | N | N | N | N | N [1] | ||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| PeripheralVascular | N | N | N | N | N | N | N [1] | ||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other | |||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD(PW) | CWD | ColorDoppler(CFM) | AmplitudeDoppler(PD) | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative(specify) | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ(specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | N | ||||||||||
| Tranesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| PeripheralVascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other | |||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD(PW) | CWD | ColorDoppler(CFM) | AmplitudeDoppler(PD) | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative(specify) | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ(specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| PeripheralVascular | N | ||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| 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 | N | N | N[1] | ||||||||
| 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+PW+CFM+M+PD
[2] Small Organs (specifically, thyroid, testicles, and breast)_
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
i
David A. Lyzom
(Division Sign-Off)
Division of Reproductive, Abdominal indinatraraj | | |quody ನಿ
{16}------------------------------------------------
Transducer: CA421
nd 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:
lar Continents:
[1] Applicable combined modes: B+M+PW+CFM+PD.
[3] Tissue Harmonic Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED
concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Layman
(Division Sign-Off) Division of Reproductive, Abdominal, mo Pa frelocal Device 年上榜首先 加速6
{17}------------------------------------------------
AppendixF
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
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:
Additional Comments:
[1] Applicable combined modes: B+PW+CFM+M+PD
[1] Applicable combined more
[1] Applicasionic Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANDITHER (ODE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ervil G. LeBaron
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Dev
{18}------------------------------------------------
AppendixF
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
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:
Additional Cominents.
[1] Applicable combined modes: 18+PW+CFM+M+PD
[1] Applicable combined modes: TFF
[3] Tissue Enhanced Imaging (TEI)
(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,
and Radiological Devices
2326
27
{19}------------------------------------------------
Fill out one form for each ultrasound system and each transducer.
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
[1] Applicable combined modes: B+PW+CFM+M+PD
(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, and Radiological Devices | |
| 510(k) Number | K050326 |
28
{20}------------------------------------------------
2.0 CW
AppendixF
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
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:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel K. Inouye
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices E10011 Al..man.
{21}------------------------------------------------
AppendixF
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
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:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lynerum
i
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices ✓
27
{22}------------------------------------------------
Transducer: EC123
lysis of the human body as follows: ﻣ
N=new indication; P=previously cleared by FDA; E= added under Appendix E
Additional Comments:
hal 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 L. Lyman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
{23}------------------------------------------------
| Transducer: TEE022 |
|---|
| This is a fluid flow analysis of the human body as follows. |
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body | 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 | N[1] | ||||||||||
| Transesophageal | N | N | N | N | N | ||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculoskeletal Superficial | |||||||||||
| Other (specify) |
(ther (specily)
N=new indication; P=previously cleared by FDA; E= added under Appendix E
Additional Comments:
aal Comments:
[1] Applicable combined modes: B+M+PW++CW+CFM+PD
[1] Applicable combined modes: B+M+PW++CW+CFM+PD
(PLEASE DO NOT WRITE BET OW THIS LINE. CONTINUE ON VAOTHER LACE IF VEEDED
CROF WEE
concurrence of CDRH, Office of Device Evaluation (ODE)
Eavid H. Sigman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 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.