(217 days)
Not Found
No
The document describes a standard ultrasound system with hardware and software for image acquisition and processing. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The focus is on real-time imaging and basic diagnostic tools.
No
The device is described as a "diagnostic ultrasound system" and its intended use is to "provide diagnostic information". It is not designed to treat a disease or medical condition.
Yes.
The "Intended Use / Indications for Use" section explicitly states, "It is possible to provide diagnostic information..." and the "Device Description" section states that the system "is intended to be a basic diagnostic tool" and "represent a transportable, software-controlled, diagnostic ultrasound system with accessories."
No
The device description explicitly states that the system is a "combination of proprietary hardware and software" and that the "Echo Blaster 128 / Echo Blaster 64 only contains the hardware and firmware". While software runs on a connected PC, the core device includes dedicated hardware.
Based on the provided text, the Echo Blaster 128 / Echo Blaster 64 ultrasound imaging systems are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens obtained from the human body. The text clearly states that the Echo Blaster systems are used for ultrasound imaging of various anatomical sites within the body (fetal, abdominal, pediatric, etc.). This is an in-vivo (within the living body) diagnostic method, not in-vitro (in glass/outside the body).
- The intended use and device description focus on real-time imaging and providing diagnostic information through ultrasound. There is no mention of analyzing biological samples like blood, urine, or tissue.
Therefore, the Echo Blaster 128 / Echo Blaster 64 systems are diagnostic imaging devices, not IVD devices.
N/A
Intended Use / Indications for Use
Echo Blaster 128 / Echo Blaster 64 ultrasound imaging systems are intended to be used for applications in fetal, abdominal, pediatric, small organ (breast, thyroid and testicles), cephalic (neonatal and adult), musculoskeletal (conventional), musculoskeletal (superficial), cardiac adult and peripheral vessel (including imaging for needle guidance, see ch.1.3). It is possible to provide diagnostic information (B, B+M and M-mode imaging) outside of an imaging lab, including at the bedside systems, for navigated medical application, in operating rooms/critical care units.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
Echo Blaster 128 / Echo Blaster 64 systems are intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning.
Echo Blaster 128 / Echo Blaster 64 system is a combination of proprietary hardware and software that has been designed for real-time imaging and is intended to be a basic diagnostic tool. The System is based on a modular and flexible architecture allowing for both mobile and stationary (installed) configurations. The system is designed for imaging with transducer ranges of 2 to 10 MHz.
The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes nor deviations from indications for use different from those demonstrated in previously cleared devices operating in ultrasound B-Mode or M-Mode, inclusive of the predicate devices so claimed.
The Echo Blaster 128 / Echo Blaster 64 only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the Echo Blaster 128 / Echo Blaster 64 via USB 2.0. Minimum requirements are given for the PC. The probes are connected to the Echo Blaster 128 / Echo Blaster 64. All Sonograms are saved on the PC and can there be evaluated, printed and archived. The Echo Wave software was especially designed for the Echo Blaster 128 / Echo Blaster 64. Software able to reside in a Windows-based PC.
The Echo Blaster 128 / Echo Blaster 64 can be used together with the appropriate probes for the entire ultrasound diagnostic (2MHz to 10MHz probes can work simultaneously for Echo Blaster 128 2Z modifications.
The devices included in this submission are as follows:
Echo Blaster 128 EXT-1Z ultrasound system utilizing as hardware and firmware an ultrasound engine contained in a small stand alone enclosure for connection to a host PC via a USB port:
Echo Blaster 128 INT-1Z / INT-2Z ultrasound systems utilizing as hardware and firmware an ultrasound engine contained in a small enclosure for insertion to a host PC (to a drive bays).
A probe, 128 element convex array, at a central ultrasonic frequency of approximately 3.5MHz, model C3.5/60/128Z.
A probe, 128 element linear array at a central ultrasonic frequency of approximately 9 MHz, model HL9.0/40/128Z
A probe, 128 element convex array at a central ultrasonic frequency of approximately 6,5 MHz. model PV6.5/10/128Z.
A probe, 128 element convex array at a central ultrasonic frequency of approximately 6.5 MHz, model L5/80/128Z.
Echo Blaster 64 EXT-1T ultrasound system utilizing as hardware and firmware an ultrasoundengine contained in a small stand alone enclosure for connection to a host PC via a USB port; A probe, 64 element convex array, at a central ultrasonic frequency of approximately 3.5 MHz, model C3.5/60/64.
A probe, 64 element linear array at a central ultrasonic frequency of approximately 7.5 MHz, model HL7.5/40/64
A probe, 64 element convex array at a central ultrasonic frequency of approximately 6.5 MHz, model PV6.5/10/64.
Mentions image processing
The main application software is Echo Wave software running on the PC, it is receiving data, processing and showing image/data on the screen. The main user interface shows an ultrasound image, controls and drop-out menus.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Pediatric, Small Organ (Breast, Thyroid and Testicles), Cephalic (Neonatal and Adult), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Cardiac Adult, Peripheral vessel.
Indicated Patient Age Range
Not Found. Applications mention Fetal, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac Adult.
Intended User / Care Setting
It is possible to provide diagnostic information (B, B+M and M-mode imaging) outside of an imaging lab, including at the bedside systems, for navigated medical application, in operating rooms/critical care units.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices in Section 1.5 Predicate Device Comparison. Maximum acoustic output level is under by the FDA recommended limit and power level is displayed all the time.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
| 510(k) Premarket Submission | ||||
|---|---|---|---|---|
| Date: DEC 20 2010 | Rev I | Pg. 1.2-3 | ||
| 510k Summary | ||||
| 1. | ldentifying information | 1 4 2011 | ||
| MAR | ||||
| Manufacturer | TELEMED | |||
| Address | Dariaus ir Gireno str. 42 Vilnius LT-02189 Lithuania | |||
| Telephone | +370-5 2106272 +370-5 2106273 | |||
| Fax | +370-5 2306733 | |||
| info@telemed.lt | ||||
| Contact | Yury Sokolov / Engineering Manager | |||
| Name of Device | Echo Blaster 64 / Echo Blaster 128 | |||
| 2. | Class and Predicate Information | |||
| Classification | Ultrasonic Pulsed Echo Imaging System | |||
| 21 CFR 892.1560, IYO | ||||
| Name | Diagnostic Ultrasonic Transducers | 21 CFR 892.1570, ITX | ||
| Common Name | Ultrasound imaging system | |||
| Propietary Name | Echo Blaster | |||
| Class | Regulatory Class II | |||
| Predicate Devices | Ardent Sound, Inc .; | Voyager | K050551 | |
| Ardent Sound, Inc .; | Seeker/Spark | K060800 | ||
| Medison America, Inc: | MYSONO 201 | K003121 |
3. Performance Standards
Performance Standards None
The Echo Blaster family has been designed to meet the following:
Safety and EMC Requirements for Medical Equipment:
IEC 60601-1: 2000, Part 1: General requirements for safety.
IEC 60601-1-2: 2001, Part 1: General requirements for basic safety and essential performance, 2.Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1-2: 2001, Part 1: General requirements for basic safety and essential performance, 2.Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1-2: 2001, Part 1: General requirements for basic safety and essential performance, 2.Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1-2: 2001, Part 1: General requirements for basic safety and essential performance, 2.Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1-4: 1996, Part 1: General Requirements for Safety, 4.Collateral Standard: Programmable Electrical Medical Systems
IEC 60601-2-37: 2007-08 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
NEMA UD 2-2004: 2003, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
NEMA UD 3-2004: 2004, Standard for Real Time Display of Thermal and Mechanical
1
| Image: Logo | Echo Blaster
510(k) Premarket Submission | | | |
|---------------------------------------|---------------------------------------------|---------|-----------|--|
| TELEMED
Ultrasound medical systems | Date: DEC 20 2010 | Rev.: 1 | Pg. 1.2-4 | |
Acoustic Output Indices on Diagnostic Ultrasound Equipment AIUM MUS: 2002, Medical Ultrasound Safety ISO-10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, 2003 ISO-10993-5, Biological Evaluation of Medical Devices Part 5: Tests for in vitro cytotoxicity , 1999 ISO-10993-10, Biological Evaluation of Medical Devices Part 10: Tests for irritation and delayed-type hypersensitivity, 2002 ISO-10993-11, Biological Evaluation of Medical Devices Part 11: Tests for systemic toxicity, 2006 IEC 62304: 2006 Medical device software -- Software life cycle processes ISO 14971:2007 Medical devices -- Application of risk management to medical devices
Essential Requirements of Council directive 93/42/EEC (Medical Device Directive)
The system's acoustic output is in accordance with ALARA principle (as low as reasonably achievable)
4. Indication for Use
Echo Blaster 128 / Echo Blaster 64 ultrasound imaging systems are intended to be used for applications in fetal, abdominal, pediatric, small organ (breast, thyroid and testicles), cephalic (neonatal and adult), musculoskeletal (conventional), musculoskeletal (superficial), cardiac adult and peripheral vessel (including imaging for needle guidance, see ch.1.3). It is possible to provide diagnostic information (B, B+M and M-mode imaging) outside of an imaging lab, including at the bedside systems, for navigated medical application, in operating rooms/critical care units.
| System | ||
|---|---|---|
| Echo Blaster 64 | Fetal*, Abdominal*, Pediatric*, Small Organ* (Breast, Thyroid, Testicles), Neonatal Cephalic, Adult Cephalic, Musculo-skeletal* (Conventional), Musculo-skeletal* (Superficial), Cardiac Adult*, Peripheral vessel* | |
| Transducers | C3.5/60/64 | Fetal*, Abdominal*, Pediatric* |
| HL7.5/40/64 | Pediatric*, Small Organ* (Breast, Thyroid, Testicles), Neonatal Cephalic, Adult Cephalic, Musculo-skeletal* (Conventional), Musculo-skeletal* (Superficial), Peripheral vessel* | |
| PV6.5/10/64 | Small Organ* (Breast, Thyroid, Testicles), Cardiac Adult*, Peripheral vessel* | |
| System | Echo Blaster 128 | Fetal*, Abdominal*, Pediatric*, Small Organ* (Breast, Thyroid, Testicles), Neonatal Cephalic, Adult Cephalic, Musculo-skeletal* (Conventional), Musculo-skeletal* (Superficial), Cardiac Adult*, Peripheral vessel* |
| Transducers | C3.5/60/128Z | Fetal*, Abdominal*, Pediatric* |
| HL9.0/40/128Z | Pediatric*, Small Organ* (Breast, Thyroid, Testicles), Neonatal Cephalic, Adult Cephalic, Musculo-skeletal* (Conventional), Musculo-skeletal* (Superficial), Peripheral vessel* | |
| PV6.5/10/128Z | ||
| L5.0/80/128Z | Small Organ* (Breast, Thyroid, Testicles), Cardiac Adult*, Peripheral vessel* | |
| Musculo-skeletal*(Conventional), Musculo-skeletal* (Superficial) |
*Including Imaging for needle guidance
2
Image /page/2/Picture/1 description: The image shows the logo for TELEMED Ultrasound medical systems. The logo consists of a diamond shape with a heart rate monitor graphic inside. To the right of the diamond is the word "TELEMED" in a bold, sans-serif font. Below the word "TELEMED" is the phrase "Ultrasound medical systems" in a smaller, serif font.
| Echo Blaster | |||
|---|---|---|---|
| 510(k) Premarket Submission | |||
| Date: DEC 20 2010 | Rev.: 1 | Pg. 1.2-5 |
5. Device Description
Echo Blaster 128 / Echo Blaster 64 systems are intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning.
Echo Blaster 128 / Echo Blaster 64 system is a combination of proprietary hardware and software that has been designed for real-time imaging and is intended to be a basic diagnostic tool. The System is based on a modular and flexible architecture allowing for both mobile and stationary (installed) configurations. The system is designed for imaging with transducer ranges of 2 to 10 MHz.
The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes nor deviations from indications for use different from those demonstrated in previously cleared devices operating in ultrasound B-Mode or M-Mode, inclusive of the predicate devices so claimed.
The Echo Blaster 128 / Echo Blaster 64 only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the Echo Blaster 128 / Echo Blaster 64 via USB 2.0. Minimum requirements are given for the PC. The probes are connected to the Echo Blaster 128 / Echo Blaster 64. All Sonograms are saved on the PC and can there be evaluated, printed and archived. The Echo Wave software was especially designed for the Echo Blaster 128 / Echo Blaster 64. Software able to reside in a Windows-based PC.
The Echo Blaster 128 / Echo Blaster 64 can be used together with the appropriate probes for the entire ultrasound diagnostic (2MHz to 10MHz probes can work simultaneously for Echo Blaster 128 2Z modifications.
The devices included in this submission are as follows:
Echo Blaster 128 EXT-1Z ultrasound system utilizing as hardware and firmware an ultrasound engine contained in a small stand alone enclosure for connection to a host PC via a USB port:
Echo Blaster 128 INT-1Z / INT-2Z ultrasound systems utilizing as hardware and firmware an ultrasound engine contained in a small enclosure for insertion to a host PC (to a drive bays).
A probe, 128 element convex array, at a central ultrasonic frequency of approximately 3.5MHz, model C3.5/60/128Z.
A probe, 128 element linear array at a central ultrasonic frequency of approximately 9 MHz, model HL9.0/40/128Z
A probe, 128 element convex array at a central ultrasonic frequency of approximately 6,5 MHz. model PV6.5/10/128Z.
A probe, 128 element convex array at a central ultrasonic frequency of approximately 6.5 MHz, model L5/80/128Z.
Echo Blaster 64 EXT-1T ultrasound system utilizing as hardware and firmware an ultrasoundengine contained in a small stand alone enclosure for connection to a host PC via a USB port; A probe, 64 element convex array, at a central ultrasonic frequency of approximately 3.5 MHz,
3
Kloaa53
Image /page/3/Picture/1 description: The image shows the logo for Telemed Ultrasound Medical Systems. The logo consists of a diamond shape with a stylized waveform inside, followed by the word "TELEMED" in bold, uppercase letters. Below "TELEMED" is the phrase "Ultrasound medical systems" in a smaller font.
| Echo Blaster | ||
|---|---|---|
| 510(k) Premarket Submission | ||
| Date: DEC 20 2010 | Rev.: I | Pg. 1,2-6 |
model C3.5/60/64.
A probe, 64 element linear array at a central ultrasonic frequency of approximately 7.5 MHz, model HL7.5/40/64
A probe, 64 element convex array at a central ultrasonic frequency of approximately 6.5 MHz, model PV6.5/10/64.
6. General Safety and Effectiveness
The Echo Blaster 128 / Echo Blaster 64 Ultrasound Systems are similar to currently distributed ultrasonic pulsed echo imaging systems.
There are no technological characteristics or features or indications for use in this Submission that are not previously evaluated and approved in the predicate devices, nor are there such technologies, features and indications for use not commonly used in the practice of diagnostic ultrasound.
The Echo Blaster Ultrasound Systems and its accessories are designed for compliance to all applicable medical devices safety standards; as referenced in DECLARATION OF CONFORMITY (Appendix 06). Prior release for manufacturing, all such devices, so designed, are tested and determined to be in full compliance with acoustic output, biocompatibility, cleaning and disinfection effectiveness. No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices in Section 1.5 Predicate Device Comparison. Maximum acoustic output level is under by the FDA recommended limit and power level is displayed all the time.
7. Patient Contact Materials
The materials of probes, coming in contact with patient are: Silicone Rubber Acrylonitrile Butadien Styrene (ABS) Polyphenylsulfone (PPSU) Standard for the biological evaluation: ISO-10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, 2003 ISO-10993-5, Biological Evaluation of Medical Devices Part 5: Tests for in vitro cytotoxicity , 1999 ISO-10993-10, Biological Evaluation of Medical Devices Part 10: Tests for irritation and delayed-type hypersensitivity, 2002
ISO-10993-11, Biological Evaluation of Medical Devices Part 11: Tests for systemic toxicity, 2006
8. Software
The Echo Blaster 128 / Echo Blaster 64 systems contain the hardware and software which collect and pro-processes 'rough'' data and send it via USB 2.0 connection to a Windows® based PC. The main application software is Echo Wave software running on the PC, it is receiving data, processing and showing image/data on the screen. The main user interface shows an ultrasound image, controls and drop-out menus. The ultrasound images and calculated/measured data can be stored
4
| | TELEMED
Ultrasound medical systems | Echo Blaster
510(k) Premarket Submission | | |
|-------|---------------------------------------|---------------------------------------------|-----|-------|
| Date: | DEC 20 2010 | Rev.: I | Pg. | 1.2-7 |
in memory.
9. Conclusion
In accordance with the FDA and based on the information provided in this Premarket notification, TELEMED concludes that the Echo Blaster 128 / Echo Blaster 64 are safe and effective and substantially equivalent to predicate devices described herein.
5
Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like figure formed by the negative space within the caduceus. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
TELEMED % Mr. Norbert Stuiber Responsible Third Party Official TÜV SÜD America, Inc. 1775 Old Highway 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891
MAR 1 4 201
Re: K102253
Trade/Device Name: ¿Echo Blaster 64' and *Echo Blaster 128' Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: February 4, 2011 Received: March 2, 2011
Dear Mr. Stuiber:
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 'Echo Blaster 64' and 'Echo Blaster 128', as described in your premarket notification:
Transducer Model Number
'Echo Blaster 64'
C3.5/60/64 Convex Array HL7.5/40/64 Linear Array PV6.5/10/64 Convex Array 'Echo Blaster 128'
C3.5/60/128Z Convex Array HL9.0/40/128Z Linear Array PV6.5/10/128Z Convex Array L5/80/128Z Linear Array
6
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 vour 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 anv 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 Shahram Vaezy at (301) 796-6242.
Sincerely Yours,
Mary S Patel
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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Image /page/7/Picture/0 description: The image shows a logo with a diamond shape on the left and the word "TELEMED" on the right. Below the word "TELEMED" is the text "Ultrasound medical systems" in a smaller font. Inside the diamond shape is a graphic that resembles a heartbeat or sound wave.
1.3 Indications for Use
All indications for use of subject devices and probes are identified in the table forms:
| System | |||
|---|---|---|---|
| Echo Blaster 64 | Fetal*, Abdominal*, Pediatric*, Small Organ* | ||
| (Breast, Thyroid, Testicles), Neonatal Cephalic, | |||
| Adult Cephalic, Musculo-skeletal* (Conventional), | |||
| Musculo-skeletal* (Superficial), Cardiac Adult*, | |||
| Peripheral vessel* | Table 1.3-1 | ||
| Transducers | C3.5/60/64 | Fetal*, Abdominal*, Pediatric* | |
| HL7.5/40/64 | Pediatric*, Small Organ* (Breast, Thyroid, Testicles), Neonatal Cephalic, Adult Cephalic, | ||
| Musculo-skeletal* (Conventional), Musculo-skeletal* (Superficial), Peripheral vessel* | |||
| PV6.5/10/64 | Small Organ* (Breast, Thyroid, Testicles), Cardiac Adult*, Peripheral vessel* | ||
| System | |||
| Echo Blaster 128 | Fetal*, Abdominal*, Pediatric*, Small Organ* | ||
| (Breast, Thyroid, Testicles), Neonatal Cephalic, | |||
| Adult Cephalic, Musculo-skeletal* (Conventional), | |||
| Musculo-skeletal* (Superficial), Cardiac Adult*, | |||
| Peripheral vessel* | Table 1.3-5 | ||
| Transducers | C3.5/60/128Z | Fetal*, Abdominal*, Pediatric* | |
| HL9.0/40/128Z | Pediatric*, Small Organ* (Breast, Thyroid, Testicles), Neonatal Cephalic, Adult Cephalic, | ||
| Musculo-skeletal* (Conventional), Musculo-skeletal* (Superficial), Peripheral vessel* | |||
| PV6.5/10/128Z | Small Organ* (Breast, Thyroid, Testicles), Cardiac Adult*, Peripheral vessel* | ||
| L5.0/80/128Z | Musculo-skeletal*(Conventional), Musculo-skeletal* (Superficial) |
*Including Imaging for needle guidance
510K
Mary S. Patil
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
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Image /page/8/Picture/0 description: The image shows the logo for TELEMED Ultrasound medical systems. The logo consists of a diamond shape with a stylized "A" inside, followed by the word "TELEMED" in bold, sans-serif font. Below "TELEMED" is the text "Ultrasound medical systems" in a smaller font size.
| Echo Blaster
| 510(k) Premarket Submission | ||
|---|---|---|
| Date: JUL 16 2010 | Rev.: C | Pg. 1.3-2 |
Diagnostic Ultrasound Indications for Use Form
System: Echo Blaster 64
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Table 1.3-1
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (specify) | Other * | ||||||||
| (specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal² | N | N | N B+M | ||||||
| Abdominal² | N | N | N B+M | ||||||
| Intraoperative (specify) | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric² | N | N | N B+M | ||||||
| Small Organ (specify) ² | N1 | N1 | N B+M | ||||||
| Neonatal Cephalic | N | N | N B+M | ||||||
| Fetal Imaging | Adult Cephalic | N | N | N B+M | |||||
| & Other | Trans-rectal | ||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (Non-Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) ² | N | N | N B+M | ||||||
| Musculo-skeletal | |||||||||
| (Superficial) ² | N | N | N B+M | ||||||
| Intravascular | |||||||||
| Other (specify) | |||||||||
| Cardiac Adult² | N | N | N B+M | ||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral vessel² | N | N | N B+M | |||||
| Vessel | Other (specify) | ||||||||
| Table 1.3-2 | |||||||||
| Clinical Application | Mode of Operation | ||||||||
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (specify) | Other * | ||||||||
| (specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal2 | N | N | N B+M | ||||||
| Abdominal2 | N | N | N B+M | ||||||
| Intraoperative (specify) | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric2 | N | N | N B+M | ||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | |||||||||
| & Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (Non-Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (specify) | |||||||||
| Clinical Application | Mode of Operation | ||||||||
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (specify) | Other * | ||||||||
| (specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intraoperative (specify) | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric² | N | N | N B+M | ||||||
| Small Organ (specify) ² | N¹ | N¹ | N B+M | ||||||
| Neonatal Cephalic | N | N | N B+M | ||||||
| Fetal Imaging | |||||||||
| & Other | Adult Cephalic | N | N | N B+M | |||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (Non-Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) ² | N | N | N B+M | ||||||
| Musculo-skeletal | |||||||||
| (Superficial) ² | N | N | N B+M | ||||||
| Intravascular | |||||||||
| Other (specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel² | N | N | N B+M | |||||
| Other (specify) | |||||||||
| Table 1.3-4 | |||||||||
| Clinical Application | Mode of Operation | ||||||||
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (specify) | Other * | ||||||||
| (specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intraoperative (specify) | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) 2 | N1 | N1 | N B+M | ||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | |||||||||
| & Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (Non-Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) 2 | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) 2 | |||||||||
| Intravascular | |||||||||
| Other (specify) | |||||||||
| Cardiac Adult2 | N | N | N B+M | ||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel2 | N | N | N B+M | |||||
| Other (specify) | |||||||||
| Clinical Application | Mode of Operation | Other * | |||||||
| (specify) | |||||||||
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal2 | N | N | N B+M | ||||||
| Abdominal2 | N | N | N B+M | ||||||
| Intraoperative (specify) | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric2 | N | N | N B+M | ||||||
| Small Organ (specify) 2 | N1 | N1 | N B+M | ||||||
| Neonatal Cephalic | N | N | N B+M | ||||||
| Fetal Imaging | |||||||||
| & Other | Adult Cephalic | N | N | N B+M | |||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (Non-Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) 2 | N | N | N B+M | ||||||
| Musculo-skeletal | |||||||||
| (Superficial) 2 | N | N | N B+M | ||||||
| Intravascular | |||||||||
| Other (specify) | |||||||||
| Cardiac Adult2 | N | N | N B+M | ||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel2 | N | N | N B+M | |||||
| Other (specify) | |||||||||
| Clinical Application | Mode of Operation | ||||||||
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (specify) | Other * | ||||||||
| (specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal² | N | N | N B+M | ||||||
| Abdominal² | N | N | N B+M | ||||||
| Intraoperative (specify) | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric² | N | N | N B+M | ||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | |||||||||
| & Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (Non-Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (specify) | |||||||||
| Table 1.3-7 | |||||||||
| Clinical Application | Mode of Operation | ||||||||
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (specify) | Other * | ||||||||
| (specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging | |||||||||
| & Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intraoperative (specify) | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric² | N | N | N B+M | ||||||
| Small Organ (specify) ² | N¹ | N¹ | N B+M | ||||||
| Neonatal Cephalic | N | N | N B+M | ||||||
| Adult Cephalic | N | N | N B+M | ||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (Non-Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) ² | N | N | N B+M | ||||||
| Musculo-skeletal | |||||||||
| (Superficial) ² | N | N | N B+M | ||||||
| Intravascular | |||||||||
| Other (specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel² | N | N | N B+M | |||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under this appendix
Note 1 - Small Organs (specifically Breast, Thyroid, Testicles)
Note 2 - Including imaging for needle guidance
Mary Spatola
(Division Sign-Off)
Division of Radiological Device Office of In Vitro Diagnostic Device Ev and Safety
510K Y102253
9
Image /page/9/Picture/0 description: The image shows the logo for TELEMED Ultrasound medical systems. The logo consists of a diamond shape with a graphic inside, followed by the word "TELEMED" in bold, sans-serif font. Below "TELEMED" is the text "Ultrasound medical systems" in a smaller font size.
Date: JUL 16 2010 Rev.: C
Pg. 1.3-3
Diagnostic Ultrasound Indications for Use Form
System: Echo Blaster 64
Transducer: Convex array C3.5/60/64
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 this appendix
Note 1 -Small Organs (specifically Breast, Thyroid, Testicles)
Note 2 - Including imaging for needle guidance
Mary S Potter
(Division Sign-Off)
510K.
Division of Radiologic Office of In Vitro
10
Image /page/10/Picture/0 description: The image shows the logo for TELEMED Ultrasound medical systems. The logo consists of a diamond shape with a stylized waveform inside, followed by the word "TELEMED" in bold, sans-serif font. Below "TELEMED" is the text "Ultrasound medical systems" in a smaller font size.
Rev.: C
Diagnostic Ultrasound Indications for Use Form
System: Echo Blaster 64
Transducer: Linear array HL7.5/40/64
Pg. 1.3-4
lntended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Table 1.3-3
Date: JUL 16 2010
N= new indication; P= previously cleared by FDA; E= added under this appendix
Note 3 - Small Organs (specifically Breast, Thyroid, Testicles)
Note 2 - Including imaging for needle guidance
Man Shatl
(Division Sign-Off)
Division of Radiological De Office of In Vitro iaonostic Device Fr n and Safety
510K
11
Image /page/11/Picture/0 description: The image shows the logo for TELEMED Ultrasound medical systems. The logo consists of a diamond shape with a stylized waveform inside, followed by the word "TELEMED" in bold, uppercase letters. Below "TELEMED" is the phrase "Ultrasound medical systems" in a smaller font.
Rev.: C
Pg. 1.3-5
Diagnostic Ultrasound Indications for Use Form
System: Echo Blaster 64
Transducer: Convex array PV6.5/10/64
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Date: JUL 16 2010
N= new indication; P= previously cleared by FDA; E= added under this appendix
Note 1 - Small Organs (specifically Breast, Thyroid, Testicles)
Note 2 - Including imaging for needle guidance
Mary Slattery
(Division Sign-Off)
Division of Re Office of In V
510K K102253
12
Image /page/12/Picture/0 description: The image shows the logo for TELEMED Ultrasound medical systems. The logo consists of a diamond shape with a waveform inside, followed by the word "TELEMED" in bold, uppercase letters. Below the word "TELEMED" is the phrase "Ultrasound medical systems" in a smaller font.
Date: JUL 16 2010 Rev.: C
Pg. 1.3-6
Diagnostic Ultrasound Indications for Use Form
System:
Echo Blaster 128 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Table 1.3-5
Table 1.3-5
N= new indication; P= previously cleared by FDA; E= added under this appendix
Note 1 -Small Organs (specifically Breast, Thyroid, Testicles)
Note 2 - Including imaging for needle guidance
Musshell
(Division Sign-Off)
Division of Radiological Dev Office of In Vitro Diagnos and Safety
510K K102253
13
Image /page/13/Picture/0 description: The image shows a logo for Telemed Ultrasound Medical Systems. The logo features a diamond shape with a stylized waveform inside, followed by the word "TELEMED" in bold, sans-serif font. Below "TELEMED" are the words "Ultrasound medical systems" in a smaller font size.
Date: JUL 16 2010 Rev.: C
Pg. 1.3-7
Diagnostic Ultrasound Indications for Use Form
System: Echo Blaster 128
Transducer: Convex array C3.5/60/128Z
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 this appendix
Note 1 -Small Organs (specifically Breast, Thyroid, Testicles)
Note 2 - Including imaging for needle guidance
Mury Patil
(Division Sign-Off)
Division of Radiologics Office of In Vitro Diagnostic Device Eva
510K
14
Image /page/14/Picture/0 description: The image shows the logo for TELEMED Ultrasound medical systems. The logo consists of a diamond shape with a heart rate graphic inside. To the right of the diamond is the word TELEMED in bold, followed by the words Ultrasound medical systems in a smaller font.
Pg. 1.3-8
Rev.: C
.
Diagnostic Ultrasound Indications for Use Form
System: Echo Blaster 128
Transducer: Linear array HL9.0/40/128Z
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Date: JUL 16 2010
N= new indication; P= previously cleared by FDA; E= added under this appendix
Note 1 - Small Organs (specifically Breast, Thyroid, Testicles)
Note 2 - Including imaging for needle guidance
Muss S Patel
(Division Sign-Off)
510K
Office of In Vitro
15
Image /page/15/Picture/0 description: The image shows the logo for TELEMED Ultrasound medical systems. The logo consists of a diamond shape with a waveform inside, followed by the word "TELEMED" in bold, uppercase letters. Below the word "TELEMED" is the phrase "Ultrasound medical systems" in a smaller font size. The logo appears to be printed in black ink on a white background.
Rev.: C
Pg. 1.3-9
Diagnostic Ultrasound Indications for Use Form
System: Echo Blaster 128
Transducer: Convex array PV6.5/10/128Z
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Table 1.3-8
Date: JUL 16 2010
| Clinical Application | | Mode of Operation | | | | | | Other *
(specify) |
|---------------------------|--------------------------------------|-------------------|----|-----|-----|------------------|-----------------------|----------------------|
| General
(Track 1 Only) | Specific
(Track 1 & 3) | B | M | PWD | CWD | Color
Doppler | Combined
(specify) | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intraoperative (specify) | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (specify) 2 | N1 | N1 | | | | N B+M | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging
& Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (Non-Card) | | | | | | | |
| | Musculo-skeletal
(Conventional) 2 | | | | | | | |
| | Musculo-skeletal
(Superficial) 2 | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (specify) | | | | | | | |
| | Cardiac Adult2 | N | N | | | | N B+M | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (specify) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel2 | N | N | | | | N B+M | |
| | Other (specify) | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under this appendix
Note 1 - Small Organs (specifically Breast, Thyroid, Testicles)
Note 2 - Including imaging for needle guidance
Mayshsted
(Division Sign-Off)
Office of In Vitro Diagnostic D
510K K102253
16
Pg. 1.3-10
Diagnostic Ultrasound Indications for Use Form
System: Echo Blaster 128
Transducer: Linear array L5/80/128Z
Rev.. C
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Date: JUL 17 2010
| Table 4.3-1 | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (specify) | Other * | |||||||
| (specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intraoperative (specify) | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (Non-Card) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) 2 | N | |||||||
| Musculo-skeletal | ||||||||
| (Superficial) 2 | N | |||||||
| Intravascular | ||||||||
| Other (specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Intravascular (Cardiac) | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (specify) |
N= new indication; P= previously deared by FDA; E= added under this appendix
Note 1 - Small Organs (specifically Breast, Thyroid, Testicles)
Note 2 - Including imaging for needle guidance
May Srostel
(Division Sign-Off)
Division of Radiological Device Vitro Diagnostic Device Evaluation and Safety Office of In
510K K102253