Predicate Devices

K#043563, K#053346, K#061189, K#010631, K#992663

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms like deep learning or neural networks. The description focuses on standard ultrasound technology and hardware modifications.

Therapeutic

No
The device is described as an "ultrasound diagnostic imaging system," which is used for obtaining diagnostic images rather than providing therapy.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states "The DP-9900 Digital Ultrasonic Diagnostic Imaging System..." and lists various diagnostic applications such as "fetal organ. abdominal, pediatric, small organs, neonatal cephalic, cardiac, transvaginal, peripheral vascular, and musculo-sletal". The "Device Description" also refers to it as an "ultrasound diagnostic system".

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Digital Ultrasonic Diagnostic Imaging System with added transducer" and describes hardware components like probes and boards, indicating it is not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
Device Function: The DP-9900 Digital Ultrasonic Diagnostic Imaging System is an ultrasound system. It works by sending sound waves into the body and receiving the echoes to create images of internal structures. This is an in vivo (within the living body) diagnostic method, not an in vitro method.
Intended Use: The intended use clearly describes imaging of internal organs and structures within the body (fetal organ, abdominal, cardiac, etc.). This aligns with in vivo diagnostic imaging.

Therefore, the DP-9900 Digital Ultrasonic Diagnostic Imaging System is a diagnostic imaging device, but it is not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The DP-9900 Digital Ultrasonic Diagnostic Imaging System with added transducer is a general-purpose, fully digital ultrasound system for abdominal, gynecologic and obstetric, small parts, and cardiac applications.

The system is intended to use for the following type of studies: fetal organ. abdominal, pediatric, small organs, neonatal cephalic, cardiac, transvaginal, peripheral vascular, and musculo-sletal (both conventional and superficial). This device is intended to adult, pregnant woman, pediatric and neonate. The Device is a prescription device intended to be used by or on the order of a physician or similarly qualified health care professional. This Device is not intended for home use.

Product codes (comma separated list FDA assigned to the subject device)

IYO, ITX

Device Description

The DP-9900 Digital Ultrasonic Diagnostic Imaging System with added transducer is a general purpose, mobile, software controlled, ultrasound diagnostic system. This ultrasonic device is designed to project ultrasound waves into body tissue and to present the returned echo information on the monitor. The resulting information is displayed in B-Mode, M-Mode, or in the combined mode (i.e. B/M-Mode). This system is a Track 1 device that employs an array of probes that include linear array and convex linear array with a frequency range of approximately 2.5 MHz to 10 MHz. The modification will provide users with two new transducers, provide new frequency point, improve imaging enhancement, change system implement protocol by integrating some boards into one and reducing some boards, etc.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic Pulsed Echo Imaging System

Anatomical Site

fetal organ, abdominal, pediatric, small organs, neonatal cephalic, cardiac, transvaginal, peripheral vascular, musculo-skeletal (both conventional and superficial), transrectal

Indicated Patient Age Range

adult, pregnant woman, pediatric and neonate

Intended User / Care Setting

to be used by or on the order of a physician or similarly qualified health care professional. This Device is not intended for home use.

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)

Laboratory testing was conducted to verify that the DP-9900 digital ultrasonic diagnostic imaging system with added transducer met all design specification and was substantially equivalent to the currently marketed Predicate Device as above. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility. Acoustic output is measured and calculated according to "Acoustic Output Measuring Standard for Diagnostic Ultrasound Equipment". No clinical testing was required.

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.

K#043563, DP-9900 Digital Ultrasonic Diagnostic Imaging System K#053346, DP-9900 Digital Ultrasonic Diagnostic Imaging System K#061189, DP-9900 Digital Ultrasonic Diagnostic Imaging System K#010631, Toshiba SSA-550A Diagnostic Ultrasound System K#992663, Aloka SSD-5000 Diagnostic Ultrasound System

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

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.

Summary

0

MAR 2 3 2007

Exhibit A 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: k 0 70 5 2 6

Submitter:

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Tel: +86 755 2658 2888

Fax: +86 755 2658 2680

· Contact Person:

Li Dongling Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

· Date Prepared:

Feb.8, 2007

Name of the device:

· Trade/Proprietary Name: DP-9900 Digital Ultrasonic Diagnostic Imaging System
· Common Name: Diagnostic Ultrasound System and Transducers
· Classification

Regulatory Class: II

21CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO) 21CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

Legally Marketed Predicate Device:

1

K#043563, DP-9900 Digital Ultrasonic Diagnostic Imaging System K#053346, DP-9900 Digital Ultrasonic Diagnostic Imaging System K#061189, DP-9900 Digital Ultrasonic Diagnostic Imaging System K#010631, Toshiba SSA-550A Diagnostic Ultrasound System K#992663, Aloka SSD-5000 Diagnostic Ultrasound System

Description:

The DP-9900 Digital Ultrasonic Diagnostic Imaging System with added transducer is a general purpose, mobile, software controlled, ultrasound diagnostic system. This ultrasonic device is designed to project ultrasound waves into body tissue and to present the returned echo information on the monitor. The resulting information is displayed in B-Mode, M-Mode, or in the combined mode (i.e. B/M-Mode). This system is a Track 1 device that employs an array of probes that include linear array and convex linear array with a frequency range of approximately 2.5 MHz to 10 MHz. The modification will provide users with two new transducers, provide new frequency point, improve imaging enhancement, change system implement protocol by integrating some boards into one and reducing some boards, etc.

Statement of intended Use:

The DP-9900 Digital Ultrasonic Diagnostic Imaging System with added transducer is a general-purpose, fully digital ultrasound system for abdominal, gynecologic and obstetric, small parts, and cardiac applications.

The system is intended to use for the following type of studies: fetal organ. abdominal, pediatric, small organs, neonatal cephalic, cardiac, transvaginal, peripheral vascular, and musculo-sletal (both conventional and superficial). This device is intended to adult, pregnant woman, pediatric and neonate. The Device is a prescription device intended to be used by or on the order of a physician or similarly qualified health care professional. This Device is not intended for home use.

Technological Characteristics:

The DP-9900 digital ultrasonic diagnostic imaging system with added transducer incorporates the same fundamental technology as the predicate device. The device has been tested as Track 1 Device per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued September 1997. The acoustic output is measured and calculated per NEMA UD 2 Acoustic Output

0028

2

Measurement Standard for Diagnostic Ultrasound Equipment: 2004. All transducers used with the DP-9900 digital ultrasonic diagnostic imaging system are track 1. All patient contact materials are biocompatible. The technology characteristics of the DP-9900 digital ultrasonic diagnostic imaging system with these modifications do not affect the safety or efficacy of

Testing:

the device.

Laboratory testing was conducted to verify that the DP-9900 digital ultrasonic diagnostic imaging system with added transducer met all design specification and was substantially equivalent to the currently marketed Predicate Device as above. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility. Acoustic output is measured and calculated according to "Acoustic Output Measuring Standard for Diagnostic Ultrasound Equipment"

Applicable Standards

The DP-9900 digital ultrasonic diagnostic imaging system with added transducer conforms to the following Standards:

NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic ultrasound Equipment IEC 60601-1 IEC 60601-1-2

IEC 60601-2-37

Clinical Test:

No clinical testing was required

Conclusion:

The conclusions drawn from testing of the DP-9900 Digital Ultrasonic Diagnostic Imaging System with added transducer demonstrates that the device is as safe, as effective as well as the legally marketed predicate devices.

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. c/o Ms. Susan D. Goldstein-Falk mdi Consultants, Inc. 55 Northern Blvd., Suite 200 GREAT NECK NY 11021

MAR 2 3 2007

Re: K070526

Trade Name: DP-9900 Digital Ultrasonic Diagnostic Imaging System Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: February 8, 2007 Received: February 23, 2007

Dear Ms. Goldstein-Falk:

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 DP-9900 Digital Ultrasonic Diagnostic Imaging System, as described in your premarket notification:

Transducer Model Number

65EC10HA 75L38HA 75L60HB 75L60HB 75L38HB 35C20HA 35C50HA 65C15HA

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Susan Goldstein-Falk

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Sunder Rajan at (240) 276-3666.

Sincerely yours,

Daniel A. Seymour

for

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

5

System × Transducer DP-9900 Model:

510(k) Number(s)

| Clinical Application (specify) | Other*
(specify) |
|------------------------------| | | A Doppler | Amplitude
Doppler | Color
Velocity
Imaging | | | Ophthalmic | | Fetal | | Abdominal | | Intraoperative (specify) | | Intraoperative Neurological | | Pediatric | | Small organ(specify) | | Neonatal Cephalic | | Adult Cephalic | | Cardiac | | Transesophageal | | Transrectal | | Transvaginal | | Transurethral | | Intravascular | | Peripheral Vascular | | Laparoscopic | | Musculo-skeletal | | Conventional | | Musculo-skeletal Superficial | | Other (specify) | | Mode of Operation | | | | | | | | Combined
-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|
| B | M | PWD | CWD | Color
|
| | | | | | | | | |
| P | P | | | | | | P | P |
| P | P | | | | | | P | P |
| | | | | | | | | |
| | | | | | | | | |
| P | P | | | | | | P | |
| P | P | | | | | | P | |
| P | P | | | | | | P | |
| | | | | | | | | |
| P | P | | | | | | P | |
| | | | | | | | | |
| P | P | | | | | | P | |
| P | P | | | | | | P | |
| | | | | | | | | |
| | | | | | | | | |
| P | P | | | | | | P | |
| | | | | | | | | |
| P | P | | | | | | P | |
| | | | | | | | | |
| P | P | | | | | | P | |
| | | | | | | | | |

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments: Combined mode: B+M

Other* : Tissue Harmonic Imaging. The feature does not use contrast agents

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

0033

6

System Transducer × Model: 35C20HA

510(k) Number(s)

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal		P	P	P			P
Intraoperative (specify)
Intraoperative Neurological
Pediatric		P	P	P			P
Small organ(specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P			P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
Other (specify)

N=new indication: P=previously cleared by FDA: E=added under Appendix EN=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments: Combined mode: B+M

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

0034

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System Transducer × Model: 35C50HA 510(k) Number(s)

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other* (specify)
Ophthalmic
Fetal		P	P						P	P
Abdominal		P	P						P	P
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small organ(specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
Other (specify)

N=new indication: P=previously cleared by FDA F=added under Appendix F

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments: Combined mode: B+M

Other* : Tissue Harmonic Imaging. The feature does not use contrast agents

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

David L. Ingram
(Division Sign-Off)

Division of Reproductive, Abdon and, and Radiological Devices 510(k) Number

0035

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System	Transducer	X
Model:	65EC10HA
510(k) Number(s)

TO(K) Number (3

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small organ(specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P				P
Transvaginal		P	P				P
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
Other (specify)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments: Combined mode: B+M

(PLEASE DO NOT WRIFE BELOW THIS LINE-CONTAIN JE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office & Berice Francation ੀ ਸ (Division Sign-Off) Division of Reproductive, Abactive, Abaction

Radiological Devices

510(k) Number

12.11

0036

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System	Transducer	×
Model:	75L38HA
510(k) Number(s)

Mode of Operation Color Clinical Application Color Amplitude Combined Other PWD CWD A B M Velocity Doppler Doppler (specify) (specify) Imaging Ophthalmic Fetal Abdominal Intraoperative (specify) Intraoperative Neurological Pediatric Small organ(specify) P P P P P Neonatal Cephalic P Adult Cephalic Cardiac Transesophageal Transrectal Transvaginal Transurethral Intravascular Peripheral Vascular P P P Laparoscopic Musculo-skeletal P P P Conventional Musculo-skeletal Superficial P P P Other (specify)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments: Combined mode: B+M

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

David A. Heymann
(Division Sign-Off)

eproductive, Abdominal, and

0037

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Transducer System × Model: 75L60HB

510(k) Number(s)

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small organ(specify)		P	P				P
Neonatal Cephalic		P	P				P
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P				P
Laparoscopic
Musculo-skeletal		P	P				P
Conventional
Musculo-skeletal Superficial		P	P				P
Other (specify)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments: Combined mode: B+M

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

David h. Loggins
(Division Sign-Off)

0038

Division of Reproductive, Abdominal, and Radiological Devices Koproductive, Abdomin

11

× System Transducer 75L38HB Model:

510(k) Number(s)

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small organ(specify)		N	N				N
Neonatal Cephalic		N	N				N
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N				N
Laparoscopic
Musculo-skeletal
Conventional		N	N				N
Musculo-skeletal Superficial		N	N				N
Other (specify)

N=new indication; P=previously cleared by FDA; E=added under Appendix E Additional comments: Combined mode: B+M

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

Daniel be Segman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510/k) Numher

0039

12

System Transducer × Model: 65C15HA 510(k) Number(s)

Mode of Operation Color Clinical Application Color Amplitude Combined Other Velocity PWD CWD A B M Doppler Doppler (specify) (specify) Imaging Ophthalmic Fetal Abdominal N N N Intraoperative (specify) Intraoperative Neurological -Pediatric N N N Small organ(specify) Neonatal Cephalic N N N Adult Cephalic Cardiac Transesophageal Transrectal Transvaginal Transurethral Intravascular Peripheral Vascular Laparoscopic Musculo-skeletal Conventional Musculo-skeletal Superficial Other (specify)

N=new indication; P=previously cleared by FDA; E=added under Appendix E Additional comments: Combined mode: B+M

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

David R. Logemann

of Reproductive, Abdominal, and cal Devicr

0040