← Product Code [IYN](/productcode/IYN) · K113612
# AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A (K113612)
_Panasonic Healthcare Co., Ltd. · IYN · Feb 10, 2012 · Radiology · SESE_
**Canonical URL:** https://fda-staging.innolitics.com/device/K113612
## Device Facts
- **Applicant:** Panasonic Healthcare Co., Ltd.
- **Product Code:** [IYN](/productcode/IYN.md)
- **Decision Date:** Feb 10, 2012
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1550
- **Device Class:** Class 2
- **Review Panel:** Radiology
## Indications for Use
The AIDA V1.5 Diagnostic Ultrasound System GM-72P00A is intended for Peripheral Vessel applications. The system provides an automated intima-media thickness measurement of peripheral vessels such as the common carotid in the BIMT-mode of operation for heart rate range of 20-150 beats per minute. The AIDA V1.5 Diagnostic Ultrasound System GM-72P00A is contraindicated for fetal use.
## Device Story
Portable ultrasound system for non-invasive peripheral vessel examination; performs automated intima-media thickness (IMT) measurement of peripheral arteries (e.g., common carotid); utilizes real-time Brightness and Color Doppler imaging to identify arterial plaques. User inputs traditional cardiovascular risk factors via touchscreen keyboard; system integrates IMT measurements with built-in calculators (Framingham, PROCAM, Reynolds, SCORE) to generate comprehensive cardiovascular risk assessment reports. Used in clinical settings by healthcare professionals to assist in cardiovascular risk stratification and patient management.
## Clinical Evidence
No clinical data provided; substantial equivalence based on technological characteristics and bench testing compliance with safety standards (UL 60601-1, IEC 60601 series, ISO 10993, NEMA UD 2/3).
## Technological Characteristics
Portable ultrasound system; B-mode and Color Doppler imaging; BIMT (B-mode + IMT) combined mode. Complies with IEC 60601-1, IEC 60601-2-37, ISO 10993 (biocompatibility), NEMA UD 2, and NEMA UD 3. Software compliant with IEC 62304.
## Regulatory 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.
## Predicate Devices
- AIDA Diagnostic Ultrasound System GM-72P00A ([K103148](/device/K103148.md))
- Viamo SSA-640A ([K093171](/device/K093171.md))
## Submission Summary (Full Text)
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FEB 1 0 2012
Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and letters. The sequence starts with the letter 'K', followed by the number '11', then '3612'. The characters are written in a simple, slightly irregular style, giving them a casual, handwritten appearance.
Panasonic Healthcare Co., Ltd
510(k) Premarket Notification AIDA V1.5 Diagnostic Ultrasound System GM-72P00A
# Chapter 4. 510(k) Summary
| Submitter's Name: | Panasonic Healthcare Co., Ltd. |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Medical Imaging Business Unit
600 Saedo-Cho, Tsuzuki-Ku
Yokohama, 224-8539 Japan |
| Contact: | Keijiro Asayama, Division Director |
| Telephone: | +81 45 939 1010 |
| Date: | December 5, 2011 |
| Trade Name: | AIDA V1.5 Diagnostic Ultrasound System GM-72P00A |
| Model No: | GM-72P00A |
| Common Name: | Ultrasound Imaging System |
| Classification Name(s): | Ultrasonic Pulsed Doppler Imaging System (21 CFR 892.1550)
Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560)
Diagnostic Ultrasound Transducer (21 CFR 892.1570) |
| Classification Number(s): | 90-ΙΥΝ; 90-IYO; 90-ITX |
| Regulatory Class: | Class II |
| Predicate Device(s): | K103148 - AIDA Diagnostic Ultrasound System GM-72P00A,
Panasonic Healthcare Co., Ltd
K093171 - Viamo SSA-640A,
Toshiba America Medical Systems, Inc. |
| Device Description: | The AIDA V1.5 Diagnostic Ultrasound System GM-72P00A is a portable
ultrasound system optimized to perform a non-invasive examination o
the peripheral vessels. It provides an automated measurement of the
intima-media thickness (IMT) of peripheral arteries such as the commo
carotids and allows the user to search for arterial plaques using real-
time Brightness and Color Doppler imaging modes. The touchscreen |
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keyboard allows the user to input various parameters relating to traditional cardiovascular risk factors. A built in calculator provides risk scores commonly used in a variety of geographical locations (Framingham Risk Score, PROCAM Health Check Score, Reynolds Risk Score, Risk score based on the SCORE Project). This information is supplemented with an IMT measurement of the artery to generate a comprehensive report of cardiovascular risk assessment.
The AIDA V1.5 Diagnostic Ultrasound System GM-72P00A is designed to comply with the following standards:
UL 60601-1: 2003; IEC 60601-1-1: 2000; IEC 60601-1-2: 2nd Edition (2001), Amendment 1 (2004); IEC 60601-2-37: 2001, Amendment 1 (2004), Amendment 2 (2005); IEC 62304: Ed. 1.0 (2006); ISO 10993-1:2009; ISO 10993-5:2009; ISO 10993-10:2010; NEMA UD 2-2004; NEMA UD 3-2004;
Intended Use:
The AIDA V1.5 Diagnostic Ultrasound System GM-72P00A is intended for Peripheral Vessel applications. The system provides an automated intima-media thickness measurement of peripheral vessels such as the common carotid in the BIMT-mode of operation for heart rate range of 20-150 beats per minute.
The AIDA V1.5 Diagnostic Ultrasound System GM-72P00A is contraindicated for fetal use.
Technological Comparison
to Predicate Device
The AIDA V1.5 Diagnostic Ultrasound System GM-72P00A is substantially equivalent to products that have already been cleared for USA distribution with 510(k) premarket notification numbers K103148 and K093171. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures. All systems permit specialized measurement of anatomic structures.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA". Inside the circle is an emblem featuring a stylized human figure with three faces in profile, representing health and well-being. The emblem is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
FEB 1 0 2012
Panasonic Healthcare Co., Ltd. % Mr. Ram Bedi President Puget Ultrasound, Inc. 2425 Squak Mountain Loop SW ISSAQUAH WA 98027
Re: K113612
Trade/Device Name: AIDA V1.5 Diagnostic Ultrasound System GM-72P00A Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: December 5, 2011 Received: December 6, 2011
Dear Mr. Bedi:
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 AIDA V1.5 Diagnostic Ultrasound System GM-72P00A, as described in your premarket notification:
Transducer Model Number
### LV13-5V1
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 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Lauren Hefner at (301) 796-6881.
Sincerely Yours,
Michael D'Aun for
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
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510(k) Premarket Notification AIDA V1.5 Diagnostic Ultrasound System GM-72P00A
## Indications for Use Statement
| 510(k) Number: | K113612 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Number: | AIDA V1.5 Diagnostic Ultrasound System GM-72P00A |
| Company Name: | Panasonic Healthcare Co., Ltd. |
| Indications for Use: | The AIDA V1:5 Diagnostic Ultrasound System GM-72P00A is intended for Peripheral Vessel applications. The system provides an automated intima-media thickness measurement of peripheral vessels such as the common carotid in the BIMT-mode of operation for heart rate range of 20-150 beats per minute. The AIDA V1.5 Diagnostic Ultrasound System GM-72P00A is contraindicated for fetal use. |
| Prescription Use | X | OR | Over-The-Counter Use | |
|------------------|---|----|----------------------|--|
|------------------|---|----|----------------------|--|
| (Per 21 CFR 801.109) | (Per 21 CFR 801 Subpart C) |
|----------------------|----------------------------|
|----------------------|----------------------------|
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 Radiological Dev Office of In Vitro Diagnostic Do
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Panasonic Healthcare Co., Ltd
### AIDA V1.5 Diagnostic Ultrasound System GM-72P00A System:
Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Clinical Application | | Mode of Operation | | | | | | |
|----------------------|---------------------------|--------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| | General
(Track 1 Only) | Specific
(Tracks 1 & 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | Other*
(Specify) |
| | Ophthalmic | Ophthalmic | | | | | | | |
| Imaging
& Other | Fetal | Fetal | | | | | | | |
| | | Abdominal | | | | | | | |
| | | Intra-operative (Specify) | | | | | | | |
| | | Intra-operative (Neuro) | | | | | | | |
| | | Laparoscopic | | | | | | | |
| | | Pediatric | | | | | | | |
| | | Small Organ (Specify) | | | | | | | |
| | | Neonatal Cephalic | | | | | | | |
| | | Adult Cephalic | | | | | | | |
| | | Trans-rectal | | | | | | | |
| | | Trans-vaginal | | | | | | | |
| | | Trans-urethral | | | | | | | |
| | | Trans-esoph. (non-Card.) | | | | | | | |
| | | Musculo-skeletal | | | | | | | |
| | | Musculo-skeletal (Superficial) | | | | | | | |
| | | Intravascular | | | | | | | |
| | | Other (Specify) | | | | | | | |
| Cardiac | | Cardiac Adult | | | | | | | |
| | | Cardiac Pediatric | | | | | | | |
| | | Intravascular (Cardiac) | | | | | | | |
| | | Trans-esoph. (Cardiac) | | | | | | | |
| | | Intra-cardiac | | | | | | | |
| | | Other (Specify) | | | | | | | |
| Peripheral
Vessel | | Peripheral vessel | P | | | | N | 1 | |
| | | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Combined mode BIMT (B + IMT)
Prescription Use Only (Per 21 CFR801.109)
---
(Division Sign-Off)
Office of In \
510K K113612
Page 2-2
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Panasonic Healthcare Co., Ltd
.
#### AIDA V1.5 Diagnostic Ultrasound System GM-72P00A System: LV13-5V1 Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|--------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General
(Track 1 Only) | Specific
(Tracks 1 & 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | Other*
(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal
Imaging
& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | P | | | | N | 1 | |
| | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Combined mode BIMT (B + IMT)
Prescription Use Only (Per 21 CFR801.109)
Divisio on and Setety
Office of In Vitro Diagnostic Device Evaluation and Safe
510k
K113612
Page 2-3
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**Source:** [https://fda-staging.innolitics.com/device/K113612](https://fda-staging.innolitics.com/device/K113612)
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