← Product Code [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN) · K200979
# DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System (K200979)
_Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · May 28, 2020 · Radiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K200979
## Device Facts
- **Applicant:** Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- **Product Code:** [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN.md)
- **Decision Date:** May 28, 2020
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1550
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** AI/ML, Pediatric
## Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: fetal, abdominal, Intra-operative (abdominal, thoracic, and vascular), pediatric, small organ (breast, thyroid, testes, etc.), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vascular.
## Device Story
Portable, software-controlled digital ultrasonic diagnostic imaging system; acquires/displays ultrasound data in B-Mode, M-Mode, PW-Mode, Color-Mode, Power/Dirpower Mode, THI, Smart3D, 4D, iScape, and Biopsy Guidance; utilizes linear and convex array probes; operated by trained clinicians in clinical settings; provides real-time visualization of anatomic structures and fluid flow; supports clinical decision-making through automated measurement tools (Smart OB, Smart Bladder, Smart Face) and workflow optimization (iWorks); benefits patients by enabling non-invasive diagnostic imaging and needle-guided procedures.
## Clinical Evidence
Bench testing only. No clinical studies were conducted. Evidence includes acoustic output measurements, biocompatibility, cleaning/disinfection effectiveness, and thermal/electrical/mechanical safety testing per recognized standards (IEC 60601-1, IEC 60601-2-37, ISO 10993-1).
## Technological Characteristics
Portable digital ultrasound system; linear and convex array transducers; B, M, PW, Color, Power/Dirpower, THI, 4D, Smart3D modes; software-controlled; connectivity via mobile trolleys (UMT-160/170); compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993-1.
## Regulatory Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
## Predicate Devices
- DP-50 Digital Ultrasonic Diagnostic Imaging System ([K111435](/device/K111435.md))
## Reference Devices
- Z6 ([K182603](/device/K182603.md))
- Resona 7 ([K171233](/device/K171233.md))
- DC-N2 ([K132779](/device/K132779.md))
- DP-6900 ([K090912](/device/K090912.md))
- DC-N3 ([K140030](/device/K140030.md))
## Submission Summary (Full Text)
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May 28, 2020
Shenzhen Mindray Bio-Medical Electronics Co., LTD. % Shi Jufang Engineer of Technical Regulation Keji 12th Road South, Hi-tech Industrial Park Shenzhen, Guangdong 518057 CHINA
#### Re: K200979
Trade/Device Name: DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: April 3, 2020 Received: April 13, 2020
#### Dear Shi Jufang:
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices 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 medical devices and radiation-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,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
#### Indications for Use
510(k) Number (if known)
K200979
Device Name
DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System
Indications for Use (Describe)
DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative (abdominal, thoracic, and vascular),pediatric, small organ(breast, thyroid, testes, etc.), neonatal and adult cephalic, transvaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vascular . The system is designed to be used by a trained operator in a clinical setting.
| 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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| Digital Ultrasonic Diagnostic Imaging System Indications For Use Format | | | | | | | | | |
|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------|---|-----|-----|---------------|--------------------|-----------------|-------------------|
| System: | DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System | | | | | | | | |
| Transducer: | N/A | | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | |
| Clinical Application | Specific (Track 1 & 3) | Mode of Operation | | | | | Combined (specify) | Other (Specify) | |
| General
(Track 1 Only) | | B | M | PWD | CWD | Color Doppler | | | Amplitude Doppler |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &
Other | Fetal | P | P | N | N | N | N | P | Note 1,2,6,7 |
| | Abdominal | P | P | N | N | N | N | P | Note 1,2,3,6,7 |
| | Intra-operative (Specify*) | N | N | N | N | N | N | N | Note 1,2,3,6 |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | N | N | N | N | P | Note 1,2,3,6 |
| | Small Organ (Specify**) | P | P | N | N | N | N | P | Note 1,2,3,6 |
| | Neonatal Cephalic | P | P | N | N | N | N | P | Note 1,2,3,6 |
| | Adult Cephalic | P | P | N | N | N | N | P | Note 1,2,6 |
| | Trans-rectal | P | P | N | N | N | N | P | Note 1,2,6 |
| | Trans-vaginal | P | P | N | N | N | N | P | Note 1,2,6 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal (Conventional) | P | P | N | N | N | N | P | Note 1,2,3,6 |
| | Musculo-skeletal (Superficial) | P | P | N | N | N | N | P | Note 1,2,3,6 |
| | Intravascular | | | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N | Note 1,2,6 |
| | Cardiac Pediatric | P | P | N | N | N | N | P | Note 1,2,6 |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral vessel | Peripheral vessel | P | P | N | N | N | N | P | Note 1,2,3,6 |
| | Other (Specify***) | | | | | | | | |
| | N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | |
| | Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power + PW +B. | | | | | | | | |
| | *Intraoperative includes abdominal, thoracic, and vascular. | | | | | | | | |
| | **Small organ-breast, thyroid, testes. | | | | | | | | |
| | ***Other use includes Urology. | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. | | | | | | | | |
| | Note 2: Biopsy Guidance | | | | | | | | |
| | Note 3: iScape | | | | | | | | |
| | Note 4: TDI | | | | | | | | |
| | Note 5: Color M | | | | | | | | |
| | Note 6: Smart3D | | | | | | | | |
| | Note 7:4D(Real-time 3D) | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | |
| | Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | | | | | | | | |
| | Prescription USE (Per 21 CFR 801.109) | | | | | | | | |
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| Digital Ultrasonic Diagnostic Imaging System Indications For Use Format | | | | | | | | | | | |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|---|------------------------|-----|---------------|-------------------|--------------------|-----------------|---------------|-------------------|
| System: | DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System | | | | | | | | | | |
| Transducer: | 35C50EA | | | | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | | | |
| | | General (Track 1 Only) | | Specific (Track 1 & 3) | | B | M | PWD | CWD | Color Doppler | Amplitude Doppler |
| | Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging & Other | Fetal | | | P | P | N | | N | N | P | Note 1,2,6 |
| | Abdominal | | | P | P | N | | N | N | P | Note 1,2,6 |
| | Intra-operative (Specify*) | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | | | P | P | N | | N | N | P | Note 1,2,6 |
| | Small Organ (Specify**) | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | P | P | N | | N | N | P | Note 1,2,6 |
| | Musculo-skeletal (Superficial) | | | | | | | | | | |
| | Intravascular | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| | | | | | | | | | | | |
| Peripheral vessel | Peripheral vessel | | | P | P | N | | N | N | P | Note 1,2,6 |
| | Other (Specify***) | | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | | | |
| | Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B. | | | | | | | | | | |
| | *Intraoperative includes abdominal, thoracic, and vascular. | | | | | | | | | | |
| | **Small organ-breast, thyroid, testes. | | | | | | | | | | |
| | ***Other use includes Urology. | | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. | | | | | | | | | | |
| | Note 2: Biopsy Guidance | | | | | | | | | | |
| | Note 3: iScape | | | | | | | | | | |
| | Note 4: TDI | | | | | | | | | | |
| | Note 5: Color M | | | | | | | | | | |
| | Note 6: Smart3D | | | | | | | | | | |
| | Note 7:4D(Real-time 3D) | | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | | |
| | Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | | | | | | | | | | |
| | Prescription USE (Per 21 CFR 801.109) | | | | | | | | | | |
| Digital Ultrasonic Diagnostic Imaging System Indications For Use Format | | | | | | | | | | | |
| System: | DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System | | | | | | | | | | |
| Transducer: | 65EC10EA | | | | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
| Clinical Application
Mode of Operation | | | | | | | | | | | |
| General (Track 1 | Specific (Track 1 & 3) | | | | | Color | Amplitude | Combined | | | |
| Only) | | B | M | PWD | CWD | Doppler | Doppler | (specify) | Other (Specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| Fetal Imaging & | Fetal | P | P | N | | N | N | P | Note 1,2,6 | | |
| Other | Abdominal | | | | | | | | | | |
| | Intra-operative (Specify*) | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | | | | | | | | | | |
| | Small Organ (Specify**) | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | P | P | N | | N | N | P | Note 1,2,6 | | |
| | Trans-vaginal | P | P | N | | N | N | P | Note 1,2,6 | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | | |
| | Intravascular | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| Peripheral vessel | Peripheral vessel | | | | | | | | | | |
| | Other (Specify***) | | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA;
E=added under Appendix E | | | | | | | | | | |
| | Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B. | | | | | | | | | | |
| | *Intraoperative includes abdominal, thoracic, and vascular. | | | | | | | | | | |
| | **Small organ-breast, thyroid, testes. | | | | | | | | | | |
| | ***Other use includes Urology. | | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. | | | | | | | | | | |
| Note 2: Biopsy Guidance | | | | | | | | | | | |
| Note 3: iScape | | | | | | | | | | | |
| Note 4: TDI | | | | | | | | | | | |
| | Note 5: Color M | | | | | | | | | | |
| | Note 6: Smart3D | | | | | | | | | | |
| | Note 7:4D(Real-time 3D) | | | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | | | |
| | Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | | | | | | | | | | |
| Prescription USE (Per 21 CFR 801.109) | | | | | | | | | | | |
| Digital Ultrasonic Diagnostic Imaging System Indications For Use Format | | | | | | | | | | | |
| System: | DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System | | | | | | | | | | |
| Transducer: | 75L38EA | | | | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | | | |
| General (Track 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (Specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| Fetal Imaging & Other | Fetal | | | | | | | | | | |
| | Abdominal | P | P | N | | N | N | P | Note 1,2,3,6 | | |
| | Intra-operative (Specify*) | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | P | P | N | | N | N | P | Note 1,2,3,6 | | |
| | Small Organ (Specify**) | P | P | N | | N | N | P | Note 1,2,3,6 | | |
| | Neonatal Cephalic | P | P | N | | N | N | P | Note 1,2,3,6 | | |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | |
| | Musculo-skeletal (Conventional) | P | P | N | | N | N | P | Note 1,2,3,6 | | |
| | Musculo-skeletal (Superficial) | P | P | N | | N | N | P | Note 1,2,3,6 | | |
| | Intravascular | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| Peripheral vessel | Peripheral vessel | P | P | N | | N | N | P | Note 1,2,3,6 | | |
| | Other (Specify***) | | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | | | |
| | Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B. | | | | | | | | | | |
| | *Intraoperative includes abdominal, thoracic, and vascular. | | | | | | | | | | |
| | **Small organ-breast, thyroid, testes. | | | | | | | | | | |
| | ***Other use includes Urology. | | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. | | | | | | | | | | |
| | Note 2: Biopsy Guidance
Note 3: iScape | | | | | | | | | | |
| | Note 4: TDI | | | | | | | | | | |
| | Note 5: Color M | | | | | | | | | | |
| | Note 6: Smart3D
Note 7:4D(Real-time 3D) | | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | | | | | | | | | | |
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| Digital Ultrasonic Diagnostic Imaging System Indications For Use Format | | | | | | | | | | |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|------------------------|---|--------------------------|-----|--------------------------|----------------------|-----------------------|--------------------|--|
| System: | DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System | | | | | | | | | |
| Transducer: | 65C15EA | | | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | | |
| General (Track
1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other (Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging
& Other | Fetal | | | | | | | | | |
| | Abdominal | P | P | N | | N | N | P | Note 1,2,6 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | N | | N | N | P | Note 1,2,6 | |
| | Small Organ (Specify**) | | | | | | | | | |
|…
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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K200979](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K200979)
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