(4 days)
No
The document does not mention AI, ML, or related terms, nor does it describe any features or performance metrics typically associated with AI/ML applications in medical imaging.
No.
The device's intended use and description explicitly state it is a "Diagnostic Ultrasound System" for "acquiring and displaying ultrasound images," with no mention of therapeutic applications.
Yes
The device name "DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System" and the "Intended Use / Indications for Use" section explicitly state that it is a "Diagnostic Ultrasound System" and is "intended for use in fetal, abdominal... and urology exams."
No
The device description explicitly states it is a "software controlled, ultrasound diagnostic system" that "employs an array of probes". This indicates the device includes hardware components (probes) in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a "Diagnostic Ultrasound System" used for various imaging exams of different anatomical sites and patient populations. This is consistent with an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.
- Device Description: The description details how the system acquires and displays ultrasound images using different modes. This is the function of an imaging system that interacts directly with the patient, not a device that analyzes samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or performing tests on specimens outside the body, which are hallmarks of IVD devices.
Therefore, the DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.
Transducer: L14-6NE
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Specific (Track 1 & 3) | Mode of Operation B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|---|
| General (Track I Only) | Ophthalmic | ||||||||
| Fetal Imaging & Other | Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | Note 1,2, 4,6,7 | ||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | Note 1,2, 4,6, | ||
| Small Organ (Specify**) | N | N | N | N | N | N | Note 1,2, 4,6,7 | ||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1,2, 4,6, | ||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | N | N | N | N | N | N | Note 1,2, 4,6, | ||
| Musculo-skeletal (Superficial) | N | N | N | N | N | N | Note 1,2, 4,6, | ||
| Cardiac | Intravascular | ||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | Peripheral vessel | N | N | N | N | N | N | Note 1,2, 4,6, | |
| 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 etc. | |||||||||
| **Small organ-breast, thyroid, testes. | |||||||||
| ***Other use includes Urology. | |||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3:4D(Real-time 3D) | |||||||||
| Note 4: iScape | |||||||||
| Note5: TDI | |||||||||
| Note6: Color M | |||||||||
| Note7: Biopsy Guidance | |||||||||
| Note8: Elastography |
Transducer: L14-6WE
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Transducer: P4-2E
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Transducer: D6-2E
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Transducer: D8-3E
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Transducer: V11-3E
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Specific (Track 1 & 3) | Mode of Operation B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|---|
| General (Track I Only) | Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | Note 1, 2, 4,6,7 | ||
| Abdominal | |||||||||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify**) | |||||||||
| Fetal Imaging & Other | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | N | N | N | N | N | N | Note 1, 2, 4,6,7 | ||
| Trans-vaginal | N | N | N | N | N | N | Note 1, 2, 4,6,7 | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | Peripheral vessel | ||||||||
| Other (Specify***) | N | N | N | N | N | N | Note 1, 2, 4,6, | ||
| 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 etc. | |||||||||
| **Small organ-breast, thyroid, testes. | |||||||||
| ***Other use includes Urology. | |||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3:4D(Real-time 3D) | |||||||||
| Note 4: iScape | |||||||||
| Note5: TDI | |||||||||
| Note6: Color M | |||||||||
| Note7: Biopsy Guidance | |||||||||
| Note8: Elastography |
Product codes
IYN, IYO, ITX
Device Description
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI mode, 4D mode or the combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 3 MHz to 10.0 MHz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology.
Indicated Patient Age Range
Adults, pregnant women, pediatric patients and neonates.
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K103583, K103677, K101236, K110199, K101757, K112596, K063085, K102256
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.
0
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(c).
The assigned 510(k) number is: