Palm Bladder Scanner - PBSV7.1 is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease.

Device Description

Palm Bladder Scanner - PBSV7.1 is a medical device with high performance combined with modern B-mode ultrasound technology and computer technology. The PBSV7.1 is composed of data processing host, 3D ultrasonic probe and application software. The 3D ultrasonic probe will transmit the collected data to the host, which will process the received data into ultrasonic images and bladder volume data. Images and data will be transmitted to the running application software on the Android system PC tablet through the USB interface.

AI/ML Overview

The provided text is a 510(k) Summary for the Palm Bladder Scanner - PBSV7.1, with a predicate device of Palm Bladder Scanner - PBSV5.1 (K191307). While it discusses safety and effectiveness, it does not include a detailed study with specific acceptance criteria and performance data for clinical use.

The document states: "Clinical testing was not performed for the subject device as part of the submission."

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample sizes and data provenance for a test set.
Number of experts and their qualifications for ground truth.
Adjudication method for the test set.
MRMC comparative effectiveness study results.
Standalone performance results.
Type of ground truth used from a clinical study.
Sample size for the training set (clinical data).
How ground truth for the training set was established (clinical data).

Based on the provided text, the device's substantial equivalence is primarily established through non-clinical testing and comparison of technological characteristics with the predicate device.

Here's what can be extracted from the document regarding performance and testing, without a clinical study:

Acceptance Criteria & Reported Performance (Based on Technical Specifications & Bench Testing):

Acceptance Criteria (Predicate/Subject Device Performance)	Reported Device Performance (PBSV7.1)
Accuracy: ±15%, ±15 ml (PBSV5.1 Predicate)	±5%(≥100mL)/ ±5mL (0~100mL)
Maximum Measurement: 999ml (PBSV5.1 Predicate)	2000ml
Dead Zone: 8mm (PBSV5.1 Predicate)	≤3mm
Patient Case Record Memory: ≤100 Pieces (PBSV5.1 Predicate)	≤10000 Pieces

Explanation of the Study and Why it Lacks Clinical Details:

A table of acceptance criteria and the reported device performance:
- As shown above, the "acceptance criteria" appear to be derived from the performance of the predicate device (PBSV5.1), and the "reported device performance" is the improved specification of the PBSV7.1. This is a comparison of technical specifications, not results from a clinical trial.
Sample sized used for the test set and the data provenance:
- Not applicable for clinical data. The document explicitly states "Clinical testing was not performed for the subject device as part of the submission."
- For non-clinical testing, the sample sizes and data provenance are not detailed in this summary. The summary mentions "non-clinical design verification and validation testing" and "comprehensive software verification and validation."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for clinical data. There was no clinical test set with a need for expert-established ground truth.
Adjudication method for the test set:
- Not applicable for clinical data.
If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. Clinical testing was not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not explicitly stated for a clinical context. The device calculates bladder volume non-invasively using an image. While the algorithm performs the calculation, its standalone performance in a clinical setting without a human using the device on a patient was not evaluated per this summary. The "software verification and validation" tests would have assessed the algorithm's performance, but not on clinical data.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for clinical data. For the non-clinical and software validation, the ground truth would have been based on defined specifications, simulated data, or phantoms, rather than clinical outcomes or expert consensus on patient data.
The sample size for the training set:
- Not applicable for clinical data. The document does not describe any training set using patient data, as no clinical testing was performed for this submission. The software was "developed and verified according to IEC 62304:2006," implying a software development process rather than a machine learning training process on a large dataset.
How the ground truth for the training set was established:
- Not applicable for clinical data.

Summary of Device Substantiation (as explained in the document):

The manufacturer claims substantial equivalence based on:

Identical intended use as the predicate device.
Similar technological characteristics, despite some differences.
Non-clinical testing: "The function and performance of Palm Bladder Scanner - PBSV7.1 has been evaluated through non-clinical design verification and validation testing." This includes:
- Compliance with various IEC and ISO standards (e.g., IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2, IEC 62133, IEC 62359, ISO 10993-5, ISO 10993-10).
- "Comprehensive software verification and validation."
The conclusion that "the design changes presented with the subject device do not raise new questions of safety and effectiveness, the subject device meets design specifications, and that the subject and predicate devices are substantially equivalent."
Improved performance over the predicate device in several key metrics (accuracy, maximum measurement, dead zone, memory capacity).

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are simple and professional in appearance.

Mianyang Meike Electronic Equipment Co., Ltd. Wenjun Zhao General Manger No.63, Yinping Road, Longmen Town, Fucheng District Mianyang, Sichuan, 621000 CHINA

Re: K210591

Trade/Device Name: Palm Bladder Scanner - PBSV7.1 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO,IYX

Dear Wenjun Zhao:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 9, 2021. Specifically, FDA is updating this SE Letter because of a clerical error in the 510(k) Summary as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jessica Lamb, Office of in vitro Diagnostics and Radiological Health, 301-796-6167, jessica.lamb@fda.hhs.gov.

Sincerely,

Michael D. O'Hara 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

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Image /page/1/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 and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The words "U.S. FOOD & DRUG" are on the first line, and "ADMINISTRATION" is on the second line.

Mianyang Meike Electronic Equipment Co., Ltd. Wenjun Zhao General Manger No.63, Yinping Road, Longmen Town, Fucheng District Mianyang, Sichuan, 621000 CHINA

Re: K210591

Trade/Device Name: Palm Bladder Scanner - PBSV7.1 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: April 20, 2021 Received: May 10, 2021

Dear Wenjun Zhao:

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 devices

June 9, 2021

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or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara
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

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Indications for Use

510(k) Number (if known) K210591

Device Name Palm Bladder Scanner - PBSV7.1

Indications for Use (Describe)

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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Image /page/4/Picture/0 description: The image shows a logo with two parts: Chinese characters at the top and the word "Meike" with a circled "R" symbol below. The Chinese characters are written in a traditional style, and the word "Meike" is in a bold, sans-serif font. The logo is in blue color. The logo likely represents a company or brand named "Meike".

007 510(k) Summary (As required by 21 CFR 807.92(a))

1.0 Submitter Information

Company:	Mianyang Meike Electronic Equipment Co., Ltd
Address	No.63, Yinping Road, Longmen Town, FuchengDistrict, Mianyang, Sichuan, 621000, CHINA
Phone:	086-13308119236
Contact	Wenjun Zhao
Title:	General Manager
Date: April. 26, 2021

2.0 Device Information

Trade/Device Name:	Palm Bladder Scanner - PBSV7.1
Model:	PBSV7.1
Common Name:	Diagnostic Ultrasound System with Accessories
Regulation Description:	Ultrasonic pulsed echo imaging system;Transducer, Ultrasonic, Diagnostic
Device:	System, Imaging, Pulsed Echo, Ultrasonic;Diagnostic ultrasonic transducer
Review Panel:	Radiology
Product Code:	IYO, ITX
Submission Type:	Special 510(k)
Regulation Number:	CFR 892.1560, CFR 892.1570
Device Class:	Class II

3.0 Predicate Device Information

Trade/Device Name:	Palm Bladder Scanner - PBSV5.1
510k Number:	K191307
Submitter:	Mianyang Meike Electronic Equipment Co., Ltd.

4.0 Device Description

5.0 Indications for Use

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Image /page/5/Picture/0 description: The image shows the word "Meike" in a stylized font, with the Chinese characters for "Meike" above it. The word "Meike" is in a dark blue color, and the Chinese characters are in a lighter blue. There is a circled "R" symbol to the right of the word "Meike", indicating that it is a registered trademark.

non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease.

6.0 Comparison of Technological Characteristics with the Predicate Device

Table 1 - Comparison table of the Subject device and Predicate device
Device Feature	Palm Bladder Scanner -PBSV7.1	Palm Bladder Scanner -PBSV5.1
510k number	K210591	K191370
Classification	CFR 892.1560, CFR 892.1570
Product code	IYO, ITX
Common name	Diagnostic Ultrasound System with Accessories
Use	Prescription Use
Indication foruse	Palm Bladder Scanner -PBSV7.1 is intended toproject ultrasound energythrough the lower abdomenof the nonpregnant patientto obtain an image of thebladder and uses that imageto calculate the bladdervolume non-invasively. It iscontraindicated for fetal useand for use on pregnantpatients. And it should notbe used by those who areallergic to coupling agentand who have abdomenwound and skin disease.	Palm Bladder Scanner -PBSV5.1 is intended toproject ultrasound energythrough the lower abdomenof the nonpregnant patientto obtain an image of thebladder and uses that imageto calculate the bladdervolume non-invasively. It iscontraindicated for fetal useand for use on pregnantpatients. And it should notbe used by those who areallergic to coupling agentand who have abdomenwound and skin disease.
Display Mode	B	B
Frequency	3.5MHz	2.6MHZ
Scan Type	Convergent	Mechanical Sector Scan
Display Screen	Universal Tablet Computer(Non-medical Device)	8.4"TFT Color LCD
Power Supply	Internal Battery(four 18650 lithiumbatteries)	Internal Battery(four 18650 lithiumbatteries)
Battery Control	Capacity Instruction forLower Power	Capacity Instruction andAlarm for Lower Power
Printer	Request Android system	Self-built printer for
	print	printing micro characters,graphic and image
Patient CaseRecord	≤10000 Pieces	100 Pieces
MaximumMeasurement	2000ml	999ml
Accuracy	±5%(≥100mL)/ ±5mL(0~100mL)	±15%,±15 ml
Dead Zone	≤3mm	8mm
Language ofInterface	English & Chinese	English

Table 1 - Comparison table of the Subject device and Predicate device

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Image /page/6/Picture/0 description: The image shows the logo for Meike. The logo consists of two Chinese characters in blue, stacked above the word "Meike" in blue, with a circled "R" symbol to the right of the word. The font of the word "Meike" is bolded.

A brief summary of the similarities and differences between Palm Bladder Scanner - PBSV7.1 and Palm Bladder Scanner - PBSV5.1 (K191307) is included below:

Similarities

Both Palm Bladder Scanner - PBSV7.1 and Palm Bladder Scanner -PBSV5.1 have the same basic science & technology and all technical features. All technical features are as follows:

· Both two devices use the piezoelectric ceramic wafers as transducers to obtain the ultrasound images of patient's bladder.
· Both two devices can obtain and process the B-type grayscale images of patient's bladder.
Both two devices can obtain the boundaries of the patient's bladder image through the same software algorithm.
Both two devices require the patient to be in a supine position.
Both two devices require an ultrasonic coupling agent to be placed between the probe sound-permeable window and the patient's skin surface for use as an ultrasound conductive medium.
Both two devices use the probe to scan and display the 12/24 B-mode ultrasound image of the patient's bladder
Both two devices use the same technology to achieve 3D image reconstruction, and use the same algorithm to calculate the volume of the reconstructed 3D image.
Both two devices use the same material of probe and host.

Differences

The summary of the differences between Palm Bladder Scanner -PBSV7.1 and Palm Bladder Scanner - PBSV5.1 are listed in the following:

Transducer Frequency
2.6 MHz for PBSV5.1 and 3.5 MHz for PBSV7.1.
· Scan type

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The scan type of the PBSV5.1 is mechanical sector scan and the PBSV7.1 uses convergent scan.

● Display screen

PBSV7.1 uses Android off-the-shelf tablet as the display screen, the PBSV5.1 uses built-in 8.4"TFT Color LCD screen.

● Printer

The PBSV5.1 has a printer as part of the device. The PBSV7.1 can print to a wireless printer available as an accessory through the off-the-shelf tablet.

● Performance

The performance of the PBSV7.1 has been greatly improved.

. Memory capacity of the patient case record has expanded from up to 100 pieces (PBSV5.1) to 10000 pieces (PBSV7.1).

· Maximum Measurement can reach to 2000ml (PBSV7.1) instead of the 999ml (PBSV5.1).

·Accuracy are improved. In PBSV5.1, there's a 15%/15ml margin of error, the PBSV7.1 managed to reduce the error to 5%/5m1. The area of dead zone reduces from 8mm to less than 3mm.

· There are more language options in the PBSV7.1- Chinese and English while the PBSV5.1 can only be operated in English.

· Software

Under the premise of not changing the user operation, we have optimized the interface UI. At the same time, PBSV7.1 have been removed the bar code scanning function and the gender switch function. The added functions are · Hospital information setting function · Batch data operation function .Data uploading .Exporting, backup and restoring function .User automatic logout function. The design and development of software meets the requirement of IEC62304.

The differences noted between Palm Bladder Scanner - PBSV7.1 and the predicate device, Palm Bladder Scanner - PBSV5.1 (K191307), do not present any new or different questions related to safety and effectiveness.

7.0 Compatibility Specifications for Universal PC Tablet

7.1 Universal PC Tablet Compatibility

Table 2 - List of Compatibility Specifications

Specification	Requirement
CPU:	Above 1.5GHz
RAM:	Above 3GB
Storage Memory:	Above 32GB
Screen:	Above 1920×1080 of Resolution

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Image /page/8/Picture/0 description: The image shows a logo with the Chinese characters "美科" in blue at the top. Below the Chinese characters, the word "Meike" is written in blue, followed by the registered trademark symbol. The logo appears to be for the brand "Meike."

Mianyang Meike Electronic Equipment Co., Ltd.

Network:	Wi-Fi, Bluetooth
USB Interface:	Type-C
OS Version:	On Android 8.0 and above
Print:	Support Wi-Fi Print
EMC and Electrical Safety:	Meet the standard of IEC60601-1 orIEC62368-1
Mobile Phone Capability:	Must approved by FCC

7.2 Warnings

Risks and safety accidents may be caused by irregular use or use of any tablet PC tablet that does not meet the specific requirements listed in the Compatibility Specifications Table for that may lead to abnormal operations of the application software or other issues.

The user must assume responsibility for assuring the performance of any tablet PC with the system other than listed in the Compatibility Specifications Table and using the tablet PC regularly.

8.0 Discussion of Tests Performed

8.1 Clinical Tests

Clinical testing was not performed for the subject device as part of the submission.

8.2 Non-Clinical Tests

The function and performance of Palm Bladder Scanner - PBSV7.1 has been evaluated through non-clinical design verification and validation testing. All necessary testing was conducted on the proposed Palm Bladder Scanner - PBSV7.1 to support a determination of substantial equivalence to the unmodified predicate device. Specifically, the impacts of the design changes presented with the subject device were evaluated through Design Control, and a number of required testing accordingly determined and subsequently performed. All necessary validation testing, including comprehensive software verification and validation, was performed, the results of which demonstrate that Palm Bladder Scanner -PBSV7.1 successfully meets design specification.

These testings confirm that the design changes presented with the subject device do not raise new questions of safety and effectiveness, the subject device meets design specifications, and that the subject and predicate devices are substantially equivalent:

Standard	Title
IEC 60601-1:2005+A1:2012	Medical Electrical Equipment - Part 1: GeneralRequirements For Basic Safety And EssentialPerformance (IEC 60601-1:2005, MOD).

Table 3 - Performance testing

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Image /page/9/Picture/0 description: The image shows a logo with Chinese characters at the top and the word "Meike" in English below. The Chinese characters are written in a traditional style, and the English word "Meike" is in a bold, sans-serif font. There is a circled "R" symbol to the right of the word "Meike", indicating that it is a registered trademark. The logo is in blue color.

Mianyang Meike Electronic Equipment Co., Ltd.

IEC 60601-2-37:2007+ AMD1 2015	Medical Electrical Equipment - Part 2-37:Particular Requirements For The Basic Safety AndEssential Performance Of Ultrasonic MedicalDiagnostic And Monitoring Equipment.
IEC 60601-1-2:2007+ AMD1 2015	Medical Electrical Equipment -- Part 1-2: GeneralRequirements For Basic Safety And EssentialPerformance -- Collateral Standard:Electromagnetic Disturbances -- RequirementsAnd Tests.
IEC 62133:2012	Secondary Cells And Batteries Containing AlkalineOr Other Non-Acid Electrolytes - SafetyRequirements For Portable Sealed SecondaryCells, And For Batteries Made From Them, ForUse In Portable Applications [Including:Corrigendum 1 (2013)].
IEC 62359: 2017	Ultrasonics - Field characterization - Test methodsfor the determination of thermal and mechanicalindices related to medical diagnostic ultrasonicfields.
ISO 10993-5:2009	Biological Evaluation Of Medical Devices -- Part5: Tests For In Vitro Cytotoxicity.
ISO 10993-10:2010	Biological Evaluation Of Medical Devices - Part10: Tests For Irritation And Skin Sensitization

The conclusion from the testing is the device is safe and effective for it's intended use, and performs as well or better than the predicate devices.

9.0 Software

The software and firmware in the Palm Bladder Scanner - PBSV7.1 has been developed and verified according to IEC 62304:2006. The verification report, traceability, and risk analysis demonstrate the PBSV7.1 operates as intended and risks mitigated in firmware have been verified.

10.0 Conclusion

First, the subject device - Palm Bladder Scanner - PBSV7.1 enjoys the same intended use with the predicate device, which forms the foundation of their substantial equivalence.

Secondly, they share almost the same technological characteristics and the differences will not affect the core usage of the subject device, which further support their substantial equivalence.

Moreover, the safety and effectiveness of Palm Bladder Scanner - PBSV7.1 have been evaluated according to appropriate standards, which ensures that the new device will not bring new safety and effectiveness concerns, that the

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Image /page/10/Picture/0 description: The image shows a logo with Chinese characters at the top and the word "Meike" in English below. The Chinese characters are stylized and appear to be a brand name. The word "Meike" is in a simple, bold font, and there is a circled "R" symbol next to it, indicating that it is a registered trademark.

subject device is substantial equivalent to the predicate device.

In a word, it is reasonable for us to conclude that the subject device - Palm Bladder Scanner - PBSV7.1 is substantially equivalent to the predicate device - Palm Bladder Scanner - PBSV5.1 (K191307).

Regulation Number and Section

§ 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.

Re: K210591

Indications for Use

Indications for Use (Describe)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

007 510(k) Summary (As required by 21 CFR 807.92(a))

1.0 Submitter Information

2.0 Device Information

3.0 Predicate Device Information

4.0 Device Description

5.0 Indications for Use

6.0 Comparison of Technological Characteristics with the Predicate Device

Similarities

Differences

● Display screen

● Printer

● Performance

· Software

7.0 Compatibility Specifications for Universal PC Tablet

7.1 Universal PC Tablet Compatibility

7.2 Warnings

8.0 Discussion of Tests Performed

8.1 Clinical Tests

8.2 Non-Clinical Tests

9.0 Software

10.0 Conclusion

§ 892.1560 Ultrasonic pulsed echo imaging system.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW