(57 days)
Not Found
No
The summary describes a standard ultrasound device for bladder volume measurement and does not mention any AI or ML capabilities.
No
The device is used for non-invasive bladder volume measurement and imaging for diagnostic purposes, not for treating a condition.
Yes
The device is described as an "ultrasound device" that "projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder Volume noninvasively." This process of using imaging and measurement to gain information about a patient's internal state (bladder volume) for medical purposes falls under the definition of diagnostics. The term "Bladder Scanner" itself implies a method of examining or analyzing.
No
The device description explicitly states it consists of a main unit, 3D/2D probe, battery, and charger, which are all hardware components. It is a B-mode pulsed-echo ultrasound device, which is a hardware-based imaging modality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The Bladder Scanner described is an ultrasound device that uses sound waves to create images of the bladder within the patient's body (in vivo). It then calculates the bladder volume based on these images.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It directly interacts with the patient's body to obtain information.
Therefore, based on the provided information, the Bladder Scanner is a medical imaging device used for non-invasive measurement, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Bladder Scanner (Models: M2, M1, M1-W) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The M2, M2-W, M1, M1-W Bladder Scanner projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder Volume noninvasively. The M2, M2-W, M1, M1-W Bladder Scanner is intended to be used only by qualified medical professionals.
Product codes
IYO, ITX
Device Description
The M Series Bladder Scanner manufactured by Suzhou Lischka Medtech Co., Ltd. provides noninvasive volume bladder measurement utilizing real-time ultrasound imaging and measurement. The equipment consists of the main unit, 3D probe (M2, M2-W)/2D probe (M1, M1-W), battery and Charger. It features:
- Two Operation Modes: Expert Mode and Easy Mode.
- Non-invasive, comfortable, correct, reliable, fast and simple operation.
- Printouts with ultrasound images and various parameters through PC software.
- Touch screen keyboard operation.
- Voice input and play functions.
- Multi-language selection.
- Information storage.
- Information printing.
- built-in battery.
The difference between these models is that the model of the probe is different. M2, M2-W is 3D probe .M1,M1-W is 2D probe. M2-W, M1-W have WIFI connection function, M2, M1 do not have WIFI connection function.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Bladder / lower abdomen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical professionals
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)
Clinical test:
Clinical testing is not required.
Non-clinical data
The M2, M2-W, M1, M1-W Bladder Scanner comply with: Safety:
-
- ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
-
- IEC 60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
Performance:
- 3. IEC 60601-2-37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
-
- NEMA UD 2 Standard for real-time display of thermal and mechanical acoustic output indies on diagnostic ultrasound equipment.
-
- Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing
Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.
- Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing
Biocompatibility:
- 6. ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
-
- ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
-
- ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
WIFI and Bluetooth connection:
- 9. FCC CFR TITLE 47 PART 15 SUBPART C SECTION 15.247
The tests were selected to show substantial equivalence between the subject device and the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Volume measurement accuracy:
M2/M2-W: ±7%, ±7ml
M1/M1-W: ±14%, ±14ml
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left, and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Suzhou Lischka Medtech Co., Ltd. % Shi Jing R&D Manager NO.999 Quija Road, Qiandeng Town Kunshan, Jiangsu 215341 CHINA
Re: K190769
Trade/Device Name: Bladder Scanner (Models: M2, M2-W, M1, M1-W) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: March 26, 2019 Received: March 26, 2019
Dear Shi Jing:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
May 22, 2019
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K190769
Device Name Bladder Scanner (Models : M2, M2-W, M1, M1-W)
Indications for Use (Describe)
The Bladder Scanner (Models: M2, M1, M1-W) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The M2, M2-W, M1, M1-W Bladder Scanner projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder Volume noninvasively. The M2, M2-W, M1, M1-W Bladder Scanner is intended to be used only by qualified medical professionals.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Diagnostic Ultrasound Indications for Use Form
System: M2
Transducer: H3D-1
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined | |
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal / Obstetrics | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Bladder) | N | |||||||
| Cardiac | Adult Cardiac | |||||||
| Pediatric Cardiac | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | |||||||
| vascular | Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
4
System: M1 Transducer: HD2-1
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PW | CW | Color | Combined (Specify) | Other (Specify) | ||
| General | Specific | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Small Organ (Specify) | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Bladder) | N | |||||||
| Cardiac | Adult Cardiac | |||||||
| Pediatric Cardiac | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | ||||||||
| vascular | Peripheral vascular | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
5
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 10 March 2019
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | Suzhou Lischka Medtech Co., Ltd. |
|---|---|
| Address: | 2F,BuildingG4, Kunshan Hi-Tech Medical Device |
| Industrial Park, NO.999 Qujia Road, Qiandeng | |
| Town, Kunshan City, Jiangsu Prov. 215341,China | |
| Contact person: | Shi Jing |
| Title: | R&D manager |
| E-mail: | shi.jing@lischka.cn |
| Tel: | +86- 512-36692288-831 |
2. Device Identification
| Trade/Device Name: | Bladder Scanner |
|---|---|
| Models: | M2, M2-W, M1, M1-W |
| Regulation Number: | 21 CFR 892.1560 |
| 21 CFR 892.1570 | |
| Regulation Name: | Ultrasonic, Pulsed echo, Imaging |
| Transducer, Ultrasonic, Diagnostic | |
| Regulation Class: | Class II |
| Product Code: | IYO, ITX |
3. Predicate Device
| 510(K) number: | K131227 |
|---|---|
| Device Name: | PadScan HD series Bladder Scanner |
| Manufacturer: | Caresono Technology Co., Ltd |
| Regulation Number: | 21 CFR 892.1560 |
| 21 CFR 892.1570 | |
| Regulation Name: | Ultrasonic, Pulsed echo, Imaging |
| Transducer, Ultrasonic, Diagnostic | |
| Regulation Class: | Class II |
| Product Code: | IYO, ITX |
6
4. Device Description
The M Series Bladder Scanner manufactured by Suzhou Lischka Medtech Co., Ltd. provides noninvasive volume bladder measurement utilizing real-time ultrasound imaging and measurement. The equipment consists of the main unit, 3D probe (M2, M2-W)/2D probe (M1, M1-W), battery and Charger. It features:
- Two Operation Modes: Expert Mode and Easy Mode .
- Non-invasive, comfortable, correct, reliable, fast and simple operation .
- Printouts with ultrasound images and various parameters through PC software .
- . Touch screen keyboard operation
- . Voice input and play functions
- Multi-language selection .
- Information storage •
- . Information printing
- . built-in battery
The difference between these models is that the model of the probe is different. M2, M2-W is 3D probe .M1,M1-W is 2D probe. M2-W, M1-W have WIFI connection function, M2, M1 do not have WIFI connection function.
5. Intended use
The Bladder Scanner (Models: M2, M2-W, M1, M1-W) projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder volume noninvasively. The Bladder Scanner is intended to be used only by qualified medical professionals.
6. Indication for use
The Bladder Scanner (Models: M2, M1, M1-W) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The M2, M2-W, M1, M1-W Bladder Scanner projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder Volume noninvasively. The M2, M2-W, M1, M1-W Bladder Scanner is intended to be used only by qualified medical professionals.
Contraindications:
Do not use the Bladder Scanner on following cases:
- a) Fetal use or pregnant patients.
- b) Patients with ascites.
- c) Patients with open or damaged skin.
- d) Wounds in the suprapubic region.
7
7. Comparison to Predicate Device
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table
| SE Comparisons | Bladder Scanner
(Models: M2, M2-W,
M1, M1-W) | PadScan HD series
Bladder Scanner | Note |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/K# | Suzhou Lischka
/Present
application | Caresono/K131227 | -- |
| Trade name and
model | Bladder Scanner
(Models: M2, M2-W,
M1, M1-W) | PadScan HD series
Bladder Scanner
(Models: HD5, HD3) | |
| Classifications
name and
Regulation Name | Regulation Number:
21 CFR 892.1560
21 CFR 892.1570
Regulation Name:
Ultrasonic, Pulsed
echo, Imaging
Transducer,
Ultrasonic, Diagnostic
Product Code: IYO,
ITX | Regulation Number:
21 CFR 892.1560
21 CFR 892.1570
Regulation Name:
Ultrasonic, Pulsed
echo, Imaging
Transducer, Ultrasonic,
Diagnostic
Product Code: IYO, ITX | Same |
| Intended Use | The Bladder Scanner
(Models: M2, M2-W,
M1, M1-W) projects
ultrasound energy
through the lower
abdomen of the
patient to obtain
images of the bladder
which is used to
calculate bladder
volume noninvasively.
The Bladder Scanner
is intended to be used
only by qualified
medical professionals. | The PadScan HD
series Bladder Scanner
projects ultrasound
energy through the
lower abdomen of the
patient to obtain images
of the bladder which is
used to calculate
bladder volume
noninvasively. The
PadScan HD series
Bladder Scanner is
intended to be used
only by qualified
medical professionals. | Same |
| Contraindications | Do not use the
Bladder Scanner on
following cases: | Do not use the
PadScan
HD Bladder Scanner on
following cases: | Same |
| | a) Fetal use or
pregnant patients
b) Patients with
ascites
c) Patients with open
or
damaged skin.
d) Wounds in the
suprapubic region | a) Fetal use or pregnant
patients
b) Patients with ascites
c) Patients with open or
damaged skin.
d) Wounds in the
suprapubic region | |
| Modes of
operation | B mode | B mode | Same |
| System
Characteristics | Portable
LCD Display
Thermal Printer
Power source: Battery | Portable
LCD Display
Thermal Printer
Power source: Battery
or
AC-DC adapter | Different, but both our
device and predicate device
met the requirements of IEC
60601-1. The difference
does not affect the safety
and performance. |
| Display | M2: 2.4" TFT-LCD
M1: 2.4" TFT-LCD | PadScan HD2: 2.5"
TFT-LCD
PadScan HD5: 8" TFT-
LCD | Different,
The size of the display is
different and does not affect
product safety and
performance. |
| Controls for
Change of
acoustic output
during scan | No | No | Same |
| Transducer Type | Mechanical Sector
Probe | Mechanical Sector
Probe | Same |
| Measurement
place | Abdomen | Abdomen | Same |
| Transducer
Resonant
Frequency | 3.5Mhz or 2.5Mhz | 2.5Mhz | Basically the same |
| Number of
elements | 1 | 1 | Same |
| Sector Angle | 120° | 120° | Same |
| Number of Scan
Planes | M2, M2-W-12 ,
M1, M1-W-1 | PadScan HD5-12,
PadScan HD2-1 | Same |
| Patient
Contacting
Material | PE (skin contact) | PE (skin contact) | Same |
| Volume
measurement
range | 0ml-999ml | 0ml-999ml | Same |
| Volume
measurement
accuracy | M2/M2-W: ±7%,
±7ml
M1/M1-W: ±14%,
±14ml | ±15%, ±15ml | Different, Our products are
more accurate than the
predicate device, and
performed the accurate test,
the performance is better
than the predicate device
without additional risks. |
| Classification of
protection against
electric shock | Class II equipment | Class II equipment | Same |
| Applied part type | B type | B type | Same |
| Real-time
scanning | Yes (Pre-scan) | Yes (Pre-scan) | Same |
| PC Data Upload | USB connection | Using USB flash disk | Different , Compared to the
predicate devices, the way
of PC Data Upload is
changed from SD card to
USB connection
Transmission. The
difference does not affect
the Intended Use, it will not
raise safety and
effectiveness issue. |
| Power | Lithium battery:
URR18650ZY-2600
mAh(SNLB-435 )
7.4Vd.c. 2600mAh
Charger: HXY-
084V1500A-UL
AC100-240Va | AC/DC Adapter:
Input: AC100-240V,
50/60Hz,
Output: DC14V±0.5V
Battery: Li-ion
rechargeable | Different, all the electrical
safety testing has been
conducted according to IEC
60601-1: 2012, and results
showed pass, therefore,
difference between input
power will not reduce the
subject's safety and
effectiveness. Please refer
to 015 IEC60601-1 test
report of M2,M2-W,M1,M1-
W. |
| WIFI | M1, M2 does not
contain WIFI
connection
M1-W, M2-W contain
WIFI connection | Do not contain WIFI
connection. | Different, Compared with
equivalent equipment, our
products have added WIFI
and bluetooth connection
functions. We have tested
according to FCC
requirements (CFR 47
PART 15), which proves that
our products meet the
requirements for wireless
signal function safety, and
there is no unacceptable
safety and performance. |
| Bluetooth | Connect to the printer
using Bluetooth to
print a test image | Do not contain
Bluetooth connection. | requirements (CFR 47
PART 15), which proves that
our products meet the
requirements for wireless
signal function safety, and
there is no unacceptable
safety and performance. |
| Standards
compliance | IEC 60601-
1:2005+A1:2012
IEC 60601-1-2:2014
IEC 60601-2-37:2015 | IEC 60601-1:2005
+CORR.1(2006)
+CORR.2(2007)
IEC 60601-1-2:2007
IEC 60601-2-37:2007 | Different, We verified the
product with a newer
version of the standard.
Compliance with new
standards does not reduce
the subject's safety and
effectiveness. |
| FDA limit | Track 1 | Track 1 | Same |
8
Suzhou Lischka
9
Suzhou Lischka
10
Suzhou Lischka
All the differences don't affect the safety and effectiveness which is concluded after all the required testing, so no safety and effectiveness issues relating to the system come into conclusion.
8. Performance Data
Clinical test:
Clinical testing is not required.
Non-clinical data
The M2, M2-W, M1, M1-W Bladder Scanner comply with: Safety:
-
- ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
-
- IEC 60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
Performance:
-
- IEC 60601-2-37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
11
-
- NEMA UD 2 Standard for real-time display of thermal and mechanical acoustic output indies on diagnostic ultrasound equipment.
-
- Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing
Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.
Biocompatibility:
-
- ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
-
- ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
-
- ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
WIFI and Bluetooth connection:
-
- FCC CFR TITLE 47 PART 15 SUBPART C SECTION 15.247
The tests were selected to show substantial equivalence between the subject device and the predicate.
- FCC CFR TITLE 47 PART 15 SUBPART C SECTION 15.247
9. Conclusion
The M series Bladder Scanner was evaluated with safety, EMC, Biocompatibility and Acoustic Output.
The conclusions drawn from testing of the M series Bladder Scanner demonstrate that the device is as safe and effective as the legally marketed predicate devices.