(95 days)
Pie Medical's Picus 3D ultrasound system is intended to be used by a physician to perform general diagnostic ultrasound studies including cardiac, peripheral vascular, fetal, abdominal, small organ, neonatal cephalic, transrectal and transvaginal.
Not Found
This 510(k) summary describes a new ultrasound imaging system, the Picus 3D, and compares it to existing predicate devices (Pie Medical 300LC (Picus) K002880 and Esaote AU5 3D K000931) to establish substantial equivalence.
Here's an analysis of the provided information regarding acceptance criteria and studies:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" or provide a table of performance metrics with specific targets and reported results. Instead, it utilizes a "Comparison Chart for Substantial Equivalence" to demonstrate that the Picus 3D device is comparable in features and functionality to the predicate devices. The underlying acceptance criterion for this submission is that the new device is substantially equivalent to legally marketed predicate devices, meaning it does not raise new questions of safety or effectiveness.
The "reported device performance" is implicitly shown by the detailed feature comparison in the table, demonstrating that the Picus 3D either matches or is equivalent in capability to the predicate devices across various technical specifications and clinical applications. For example, regarding imaging modes, the Picus 3D includes 3D imaging, which was present in one predicate (Esaote AU5 3D K000931) but not the other (Picus K002880), indicating an expansion of capabilities while maintaining equivalence to an existing 3D device.
Here's a summary derived from the comparison chart, focusing on the features presented as comparable for establishing substantial equivalence:
| Feature | Predicate 1 (Picus K002880) | Predicate 2 (Esaote AU5 3D K000931) | Picus 3D (This submission) | Acceptance Implication (Substantial Equivalence) |
|---|---|---|---|---|
| Transducer Type | Linear, Convex | Annular Array, Mechanical Sector, Linear, Convex, Phased Array | Linear, Convex | Matches/equivalent to primary predicate K002880, while Esaote offers broader transducer types. All are established technologies. |
| 2D Freq MHz | 2.5-10 | 2.5-15 | 2.5-10 | Matches primary predicate K002880. |
| PW Freq MHz | 2.5-8 | 2.25-10 | 2.5-8 | Matches primary predicate K002880. |
| CW Freq MHz | No | 2.25-5.0 | No | Matches primary predicate K002880. |
| Probes MHz (Linear) | 5.0-10 | 5.0-13 | 5.0-10 | Matches primary predicate K002880. |
| Probes MHz (Convex) | 2.5-10 | 3.5-7.5 | 2.5-10 | Matches primary predicate K002880; broader range than Esaote. |
| Multifrequency Probes | Yes | Yes | Yes | Equivalent to both predicates. |
| Special Probes | Transvaginal, Transrectal | Transvaginal, Transrectal, Laparoscopic, Intraoperative | Transvaginal, Transrectal | Equivalent to primary predicate K002880. |
| Biopsy Attachments | Convex, Linear | Convex, Linear | Convex, Linear | Equivalent to both predicates. |
| 3D Imaging | No | Yes | Yes | Matches predicate Esaote AU5 3D K000931 for 3D functionality. |
| Real-time 2D Imaging | Yes | Yes | Yes | Equivalent to both predicates. |
| M-mode | Yes | Yes | Yes | Equivalent to both predicates. |
| PW Doppler | Yes | Yes | Yes | Equivalent to both predicates. |
| CW Doppler | No | Yes | No | Matches primary predicate K002880. |
| CFM Doppler | Yes | Yes | Yes | Equivalent to both predicates. |
| Power Doppler | Yes | Yes | Yes | Equivalent to both predicates. |
| Triplex | Yes | Yes | Yes | Equivalent to both predicates. |
| Monitor Size (inches) | SVGA 15 | SVGA 15 | SVGA 15 | Equivalent to both predicates. |
| Programmability | 10 presets | 6 presets | 10 presets | Equivalent to primary predicate K002880; better than Esaote. |
| Digital Archival | Yes | Yes | Yes | Equivalent to both predicates. |
| VCR | Yes | Yes | Yes | Equivalent to both predicates. |
| Clinical Applications | Fetal, Abdominal, Small Organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular | Broader list including Intraoperative, Pediatric, Adult Cephalic, Laparoscopic | Fetal, Abdominal, Small Organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular | Matches primary predicate K002880's scope. |
| Safety (Electrical) | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | Equivalent to both predicates. |
| Safety (Ultrasound) | Track 3 (AOD) | Track 3 (AOD) | Track 3 (AOD) | Equivalent to both predicates. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This 510(k) summary does not mention any specific test set sample sizes, data provenance, or details of a clinical study for demonstrating performance. This type of submission relies on the concept of substantial equivalence to predicate devices that have already demonstrated safety and effectiveness through their prior market clearance. The data provenance would implicitly refer to the existing clinical use and safety record of the predicate devices.
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)
Not applicable. As noted above, this 510(k) submission establishes substantial equivalence through feature comparison, not new clinical performance data with ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set requiring adjudication is described.
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
Not applicable. This is not an AI/CAD-focused device and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an ultrasound imaging system, which is a human-in-the-loop device by nature (operated by a sonographer/physician).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No new ground truth establishment is described for this submission. The "ground truth" for demonstrating safety and effectiveness relies on the established performance and safety profiles of the predicate ultrasound devices already on the market.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device that would typically require a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is described.
{0}------------------------------------------------
510(k) Summary Picus 3D Pie Medical
JAN 2 4 2003
510(k) Summary
The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR 807.92(a).
807.92(a)(1)
Submitter Information
Colleen Hittle, Official Correspondent
8000 Castleway Drive
Indianapolis, IN 46250
| Phone: | (317) 849-1916 |
|---|---|
| Facsimile: | (317) 5779070 |
| Contact Person: | Colleen Densmore |
| Date: | October 17, 2002 |
807.92(a)(2)
| Trade Name: | Picus Ultrasound Imaging Systems |
|---|---|
| Common Name: | Ultrasound Imaging System |
| Classification Name(s): | Ultrasonic pulsed doppler imaging system 892.1550Ultrasonic pulsed echo imaging system 892.1560 |
| Classification Number: | 90IYN90IYO |
807.92(a)(3)
Predicate Device(s)
| Pie | 300LC (Picus) K002880 |
|---|---|
| Esaote | AU5 3D K000931 |
FDA/CDRH/ODE/PMO
2002 OCT 21 A 10:11
RECEIVED
Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.
{1}------------------------------------------------
510(k) Summary Picus 3D Pie Medical
807.92(a)(5)
Device Description
Intended Use(s)
Pie Medical's Picus 3D ultrasound system is intended to be used by a physician to perform general diagnostic ultrasound studies including cardiac, peripheral vascular, fetal, abdominal, small organ, neonatal cephalic, transrectal and transvaginal.
{2}------------------------------------------------
510(k) Summary
Picus 3D
Pie Medical
| Comparison Chart for Substantial Equivalence | |||
|---|---|---|---|
| General characteristics | Picus K002880 | Esaote AU5 3D K000931 | Pie Medical Picus 3DThis submission |
| Transducer type | |||
| Annular Array | No | Yes | No |
| Mechanical Sector | No | Yes | No |
| Linear | Yes | Yes | Yes |
| Convex | Yes | Yes | Yes |
| Phased array | No | Yes | No |
| 2D Freq MHz | 2.5-10 | 2.5 - 15 | 2.5-10 |
| PW Freq MHz | 2.5-8 | 2.25 - 10 | 2.5-8 |
| CW Freq MHz | No | 2.25 - 5.0 | No |
| Probes MHz | |||
| Annular Array | - | 10 - 20 | - |
| Linear | 5.0-10 | 5.0 - 13 | 5.0-10 |
| Convex | 2.5-10 | 3.5 - 7.5 | 2.5 - 10 |
| Phased array | - | 2.5 - 3.5 | - |
| Multifrequency probes | Yes | Yes | Yes |
| Special probes | TransvaginalTransrectal | TransvaginalTransrectalLaparoscopicIntraoperative | TransvaginalTransrectal |
| Biopsy attachments | - | - | - |
| Convex | Yes | Yes | Yes |
| Linear | Yes | Yes | Yes |
| Imaging modes | |||
| 3D | No | Yes | Yes |
| Real time 2D | Yes | Yes | Yes |
| M-mode | Yes | Yes | Yes |
| PW Doppler | Yes | Yes | Yes |
| CW Doppler | No | Yes | No |
| CFM Doppler | Yes | Yes | Yes |
| Power Doppler | Yes | Yes | Yes |
| Triplex | Yes | Yes | Yes |
| Monitor size (inches) | SVGA 15 | SVGA 15 | SVGA 15 |
| Programmability | 10 presets | 6 presets | 10 presets |
| Pulsed Doppler | Yes | Yes | Yes |
| CW Doppler | No | Yes | No |
| Audio stereo | Yes | Yes | Yes |
| Color Doppler | Yes | Yes | Yes |
| ECG | Optional | Optional | Optional |
| General characteristics | Picus K002880 | Esaote AU5 3D K000931 | Pie Medical Picus 3D This submission |
| Digital archival capabilities | Yes | Yes | Yes |
| General characteristics | Picus K002880 | Esaote AU5 3D K000931 | Pie Medical Picus 3D |
| VCR | Yes | Yes | Yes |
| M&A Capabilities | Fetal, abdominal, small organ, neonatal cephalic, cardiac, transrectal, transvaginal & peripheral vascular | Fetal, abdominal, intraoperative abdominal, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, peripheral vascular & laparoscopic | Fetal, abdominal, small organ, neonatal cephalic, cardiac, transrectal, transvaginal & peripheral vascular |
| Safety | |||
| Electrical | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 |
| Ultrasound | Track 3 (AOD) | Track 3 (AOD) | Track 3 (AOD) |
Comparison Chart for Substantial Equivalence
{3}------------------------------------------------
{4}------------------------------------------------
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird with outstretched wings.
JAN 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pie Medical % Ms. Colleen Densmore The Anson Group 7992 Castleway Drive INDIANAPOLIS IN 46250
Re: K023512
Trade Name: Picus 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: December 19, 2002 Received: December 20, 2002
Dear Ms. Densmore:
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 Picus Ultrasound Imaging System, as described in your premarket notification:
Transducer Model Number
3.5 MHz R40 Convex array 3.5 MHz R60 Convex array 7.0 MHz R10 Convex array 7.5 MHz L40 Linear array
{5}------------------------------------------------
7.5 MHz L50 Linear array 9.5 MHz EC123 Convex array
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 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".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{6}------------------------------------------------
Picus
| System | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Mode of Operation | |||||||||
| Clinical application | A | B | M | PWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify)3D |
| Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | N | |||
| Abdominal | P | P | P | P | P | N | |||
| Intraoperative (specify) | |||||||||
| Intraoperative Neurological | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) * | P | P | P | P | P | N | |||
| Neonatal Cephalic | P | P | P | P | P | N | |||
| Adult Cephalic | |||||||||
| Cardiac | P | P | P | P | P | N | |||
| Transesophageal | |||||||||
| Transrectal | P | P | P | P | P | N | |||
| Transvaginal | P | P | P | P | P | N | |||
| Transurethral | |||||||||
| Intravascular | |||||||||
| Peripheral Vascular | P | P | P | P | P | N | |||
| Laparoscopic | |||||||||
| Musculo-skeletal | |||||||||
| Conventional | |||||||||
| Musculoskeletal Superficial | |||||||||
| Other (specify) |
N=new indication P=previously cleared by FDA E=added under Appendix E
Additional comments:
- Small organs include Thyroid, Breast and Testicles
Prescription Use
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive" Abdominal and Radiological Devices 510(k) Number -
{7}------------------------------------------------
Picus
#410501
3.5Mhz R40 Convex array
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical application | A | B | M | PWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify)3D |
| Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | N | |||
| Abdominal | P | P | P | P | P | N | |||
| Intraoperative (specify) | |||||||||
| Intraoperative Neurological | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) * | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Transesophageal | |||||||||
| Transrectal | |||||||||
| Transvaginal | |||||||||
| Transurethral | |||||||||
| Intravascular | |||||||||
| Peripheral Vascular | P | P | P | P | P | N | |||
| Laparoscopic | |||||||||
| Musculo-skeletal | |||||||||
| Conventional | |||||||||
| Musculoskeletal Superficial | |||||||||
| Other (specify) |
N=new indication P=previously cleared by FDA E=added under Appendix E
Additional comments:
Prescription Use ✓
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive A and Radiclogical Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ KOZ 3512
{8}------------------------------------------------
Picus
#410502
3.5Mhz R60 Convex array
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical application | A | B | M | PWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify)3D | |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | N | ||||
| Abdominal | P | P | P | P | P | N | ||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) * | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | N | ||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculoskeletal Superficial | ||||||||||
| Other (specify) |
N=new indication P=previously cleared by FDA E=added under Appendix E
Additional comments:
Prescription Use
✓
Nancy C Brogdon
(Division Sign-Off) ( Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
{9}------------------------------------------------
Picus
#410504
7.0Mhz R10 Convex array
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical application | A | B | M | PWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify)3D |
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intraoperative (specify) | |||||||||
| Intraoperative Neurological | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) * | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Transesophageal | |||||||||
| Transrectal | P | P | P | P | P | N | |||
| Transvaginal | P | P | P | P | P | N | |||
| 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:
Prescription Use
Nancy C. Broaddus
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 023
{10}------------------------------------------------
Picus
#410503
7.5Mhz L40 Linear array
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical application | A | B | M | PWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify)3D | |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) * | P | P | P | P | P | N | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | N | ||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculoskeletal Superficial | ||||||||||
| Other (specify) |
N=new indication P=previously cleared by FDA E=added under Appendix E
Additional comments:
Prescription Use
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
{11}------------------------------------------------
Picus
#410506
7.5Mhz L50 Linear array
| Clinical application | A | B | M | PWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify)3D |
|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intraoperative (specify) | |||||||||
| Intraoperative Neurological | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) * | P | P | P | P | P | N | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Transesophageal | |||||||||
| Transrectal | |||||||||
| Transvaginal | |||||||||
| Transurethral | |||||||||
| Intravascular | |||||||||
| Peripheral Vascular | P | P | P | P | P | N | |||
| Laparoscopic | |||||||||
| Musculo-skeletal | |||||||||
| Conventional | |||||||||
| Musculoskeletal Superficial | |||||||||
| Other (specify) |
N=new indication P=previously cleared by FDA E=added under Appendix E
Additional comments:
- Small organs include Thyroid, Breast and Testicles
Prescription Use
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal
(Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ___
{12}------------------------------------------------
Picus
#410729
9.5Mhz EC123 Convex array
| Mode of OperationCompany of Children第一位被害者有官方法181 01:08 PM | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical application ------1990 - 2007 - 2007 - 2008 - 2008 - 2008 - 2008 - 2008 - 2008 - 2000 - 2000 - 2000 - 2000 - 2000 - 2000 - 2000 - 2000 - 2000 - 2000 - 2000 - 2000 - 2000 - 2000 - 2000 - 2000 | A | B | M: | PWD | Color .Doppler | AmplitudeDoppler | . ColorVelocityImaging | Combined(specify) | Other(specify)3D |
| Ophthalmic ------- | |||||||||
| Fetal Party - 1993 114 | |||||||||
| Abdominal Amaria. | |||||||||
| Intraoperative (specify) | |||||||||
| Intraoperative Neurological | |||||||||
| Pediatric ==================================================================================================================================================================== | |||||||||
| Small Organ (specify) * | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Transesophageal | |||||||||
| Transrectal | E | E | E | E | E | N | |||
| Transvaginal | E | E | E | E | E | N | |||
| 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:
- Small organs include Thyroid, Breast and Testicles
Prescription Use /
Nancy C hogdon
l
The Company of the Children Children the Children the Children the Children the Children the Children the Children the Children the Children the Children the Children the C
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ KO225
§ 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.