(57 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ultrasound components and signal processing, not AI/ML algorithms.
No
The device is described as an "Ultrasound Diagnostic System" for "diagnostic ultrasound evaluation," not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states "The Hitachi Noblus™ Ultrasound Diagnostic System is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation".
No
The device description explicitly lists hardware components such as ultrasound transducers, a computer system, a battery, and a video monitor, indicating it is a hardware-based system with integrated software.
Based on the provided information, the Hitachi Noblus™ Ultrasound Diagnostic System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "diagnostic ultrasound evaluation" of various anatomical sites and clinical applications. This involves using ultrasound waves to create images of internal structures for diagnosis.
- Device Description: The description details components like transducers, a computer system for signal analysis, and a monitor to display images and data. These are characteristic of imaging systems, not devices that analyze samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body. IVD devices are specifically designed for this purpose.
The device is an in vivo diagnostic imaging system, meaning it performs diagnosis by examining the body directly using imaging technology.
N/A
Intended Use / Indications for Use
The Hitachi Noblus™ Ultrasound Diagnostic System is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal, Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology, and Laparoscopic clinical applications.
The modes of Operation of the Hitachi Noblus™ Ultrasound Diagnostic System are B mode, PW mode (Pulse Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, and Real Time Tissue Elastography.
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Product codes
IYN, ITX, IYO
Device Description
An ultrasound diagnostic system with the following features:
- Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the reflected echoes
- Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) in various modes of operation
- A computer system to control the transducer and analyze the signals resulting from the reflected echoes
- A standard Lithium ion computer battery to allow for system portability
- A video monitor with optional image recorder to display the computed image or derived Doppler data
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy (percutaneous, trans-rectal, trans-vaginal), Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology, Laparoscopic, Ophthalmic, Thyroid, Parathyroid, Breast, Scrotum, Penis.
Indicated Patient Age Range
Fetal, Pediatric, Neonatal (Cephalic), Adult (Cephalic, Cardiac)
Intended User / Care Setting
Trained personnel (doctor, sonographer, etc.)
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)
Non-clinical Testing: No new hazards were identified with the subject device. The subject device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards.
Clinical testing: None required
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Hitachi Hi VISION Avius Diagnostic Ultrasound Scanner [K102901]
Reference Device(s)
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
K 130308
APR
5 2013
Section 1.1a - 510(k) Summary in accordance with 21 CFR Part 807.92, Section a
- Submitter's contact name, address, telephone/fax number, date prepared:
Angela Van Arsdale RA/QA Manager Hitachi Aloka Medical, Ltd. 10 Fairfield Blvd Wallingford CT 06492 Telephone: (203) 269-5088 Ext: 346 Fax Number: (203) 269-6075
Date Prepared: February 4, 2013
- Device / Common / Classification Name:
Hitachi Noblus™ Diagnostic Ultrasound System Common name - Diagnostic Ultrasound System and Transducers Classification name - System, Imaging, Pulsed Doppler, Ultrasonic
-
- Substantially Equivalent Device(s):
Hitachi Hi VISION Avius Diagnostic Ultrasound Scanner [K102901]
- Substantially Equivalent Device(s):
-
- Device Description:
An ultrasound diagnostic system with the following features:
- Device Description:
-
Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the reflected 0 echoes
-
Ultrasound transducer accessories (standard and optional) to maximize functional usage of o transducer(s) in various modes of operation
-
A computer system to control the transducer and analyze the signals resulting from the O reflected echoes
-
A standard Lithium ion computer battery to allow for system portability O
-
A video monitor with optional image recorder to display the computed image or derived Doppler O data
-
- Indication for Use:
The Hitachi Noblus™ Ultrasound Diagnostic System is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal, Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology, and Laparoscopic clinical applications.
The modes of Operation of the Hitachi Noblus™ Ultrasound Diagnostic System are B mode, PW mode (Pulse Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, and Real Time Tissue Elastography.
1
- Comparison to predicate device:
The Hitachi Noblus™ Diagnostic Ultrasound device is technically comparable and substantially equivalent to the Hitachi HI VISION Avius Diagnostic Ultrasound Scanner [K102901]. Both systems are track 3 systems that incorporate the same fundamental and scientific technologies with the exception of the following features:
- STIC (Spatio Temporal Image) which is a new feature when compared to predicate [K102901]. . The STIC feature is not new to the Hitachi Ultrasound systems; it has been previously cleared in the HI VISION Ascendus system via K110673.
- . Standard Lithium ion Computer battery for use in the "portable" option
- . The accessories; a Biopsy Adapter [EZU-PA7L1] and a Coupler [EZU-TEATC2] which are similar in intended use and function as the accessories for the predicate device HI VISION Avius [K102901]; has historical utilization on Hitachi Ultrasound transducers and have been previously cleared on the HI VISION Ascendus via K110673.
Both the subject device and predicate device systems have the same intended use/ indications for use.
Section 1.1b - 510(k) Summary in accordance with 21 CFR Part 807.92, Section b
-
- Non-clinical Testing:
No new hazards were identified with the subject device. The subject device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards.
- Non-clinical Testing:
-
- Clinical testing:
None required
- Clinical testing:
-
- Conclusions:
The Hitachi Aloka Medical, Ltd. Noblus™ Diagnostic is substantially equivalent in safety and effectiveness to the predicate device;
- Conclusions:
-
트 The predicate and subject devices are both indicated for diagnostic ultrasound imaging and fluid flow analysis.
-
. The predicate and subject devices have the same gray scale and Doppler capabilities.
-
. The predicate and subject devices have the same essential technology for imaging. Doppler functions, and signal processing.
-
. The predicate and subject devices have acoustic level below the Track 3 FDA limits.
-
트 The predicate and subject devices are manufactured in accordance to FDA 21 CFR 820 Quality System Requlations.
-
트 The predicate and subject devices are designed and manufactured to the same electrical and physical safety standards.
-
트 The predicate and subject devices are manufactured with materials that have been tested in accordance to tripartite biocompatibility quidance and ISO 10993-1; all biocompatibility testing has been conducted in accordance to each component material characterization, type of body contact, and duration contact risk profile.
-
I The predicate and subject devices are designed to be re-usable and provide instructions for cleaning, disinfection, and sterilization in the Ultrasound system and transducer manuals.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of an eagle or bird-like figure with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
April 5, 2013
HITACHI ALOKA MEDICAL LTD c/o Angela Van Arsdale Regulatory Affairs/Quality Assurance Manager 10 Fairfield Blvd Wallingford. CT 06492
Re: K130308
Trade/Device Name: Noblus TM Ultrasound Diagnostic System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, ITX, IYO Dated: February 4, 2013 Received: February 7, 2013
Dear Angela Van Arsdale:
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. The general controls provisions of the Act include requirements for annual registration. Ilsting 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 Noblus ™ Ultrasound Diagnostic System, as described in your premarket notification:
Transducer Model Number
| C22 | EUP-CC531S | L34 |
|---|---|---|
| C25 | EUP-OL334 | L44 |
| C41 | EUP-R54AW-19,-33 | L55 |
| C41V | VC34A | L64 |
| C42 | EUP-054J | S21 |
| C42K | S31 |
3
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Smh
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(k) Number (if known): K130308
Noblus TM Ultrasound Diagnostic System Device Name:
Indications for Use:
The Noblus™ Ultrasound Diagnostic System is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-raginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology, and Laparoscopic clinical applications.
The Modes of Operation of the Noblus™ Ultrasound Diagnostic System are B mode, M mode, PW mode (Pulse " Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, and Real Time Tissue Elastography,
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) K130308
Page 1 of 19
Special 510(K)Premarket Notification - Noblus™ Ultrasound Diagnostic System
5
Device Name: Noblus™ Ultrasound Diagnostic System
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined* | ||||||||
| (Spec.) | Other** | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | P | ||
| Fetal Imaging | |||||||||
| & Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa | |
| Intra-operative (Spec.) | Pb | Pb | Pb | Pb | Pb | Pb | |||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | P | P | P | P | P | P | |||
| Pediatric | P | P | P | P | P | P | P | ||
| Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | |||
| Neonatal Cephalic | P | P | P | P | P | P | P | ||
| Adult Cephalic | P | P | P | P | P | P | P | ||
| Trans-rectal | Ph | Ph | Ph | Ph | Ph | Ph | |||
| Trans-vaginal | Pf | Pf | Pf | Pf | Pf | Pf | |||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | P | P | P | P | P | P | |||
| Musculo-skel. (Superfic.) | P | P | P | P | P | P | |||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | P | P | P | P | P | P | P | ||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P | |
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | P | P | |
| Other (spec.) |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication. P = previously cleared in K102901
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 4D Imaging, Real Time Tissue Elastography
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery |
| (excluding neurosurgery and laparoscopic procedures). | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, and penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For pediatric patients |
| Subscript "h": | Includes imaging for guidance of trans-rectal biopsy. |
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130308 510(k)
Page 2 of 19
6
Noblus™ System: Transducer: C22K
Intended use: Diagnostic uttrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Fetal Imaging | ||||||||
| & Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | |
| Intra-operative (Spec.) | Pb | Pb | Pb | Pb | Pb | Pb | ||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication. P = previously cleared in K102901
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography)
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery |
| (excluding neurosurgery and laparoscopic procedures). | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, and penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For pediatric patients |
| Subscript "h": | Includes imaging for guidance of trans-rectal biopsy. |
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) K130308
Page 3 of 19
Special 510(K)Premarket Notification – Noblus™ Ultrasound Diagnostic System
7
Noblus™ System: Transducer: C25
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Fetal Imaging | ||||||||
| & Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | |
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication. P = previously cleared in K102901
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography)
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery |
| (excludes neurosurgery and laparoscopic procedures). | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, and penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For pediatric patients |
Subscript "h": Includes imaging for guidance of trans-rectal biopsy.
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130308 510(k) -
Page 4 of 19
Special 510(K)Premarket Notification - Noblus™ Ultrasound Diagnostic System
8
Noblus™ System: Transducer C41
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | Pc | Pc | Pc | Pc | Pc | Pc | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | P |
N = new indication. P = previously cleared in K102901
*Combination of each operating mode, B, M, PWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography)
Additional Comments.
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery |
| (excludes neurosurgery and laparoscopic procedures). | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, and penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of trans-rectal biopsy. |
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130308 510(k)
Page 5 of 19
Special 510(K)Premarket Notification – Noblus™ Ultrasound Diagnostic System
9
System: Noblus™ Transducer: C41V
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows |
|---|
| ------------------------------------------------------------------------------------------------- |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other ** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Fetal Imaging | ||||||||
| & Other | Abdominal | |||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | Pe | Pe | Pe | Pe | Pe | Pe | ||
| Trans-vaginal | Pf | Pf | Pf | Pf | Pf | Pf | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
N = new indication. P = previously cleared in K102901
*Combination of each operating mode, B, M, PWD and Color Doppier.
**Amplitude Doppler (Color Flow Angiography), Real Time Tissue Elastography.
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery. |
| (excludes neurosurgery and laparoscopic procedures). | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, and penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of trans-rectal biopsy. |
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130308 510(k)
Page 6 of 19
Special 510(K)Premarket Notification - Noblus™ Ultrasound Diagnostic System
10
Noblus ™ System: Transducer: C42
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined* | ||||||||
| (Spec.) | Other** | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Fetal Imaging | |||||||||
| & Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | ||
| Intra-operative (Spec.) | Pb | Pb | Pb | Pb | Pb | Pb | |||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | |||
| Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | |||
| Neonatal Cephalic | P | P | P | P | P | P | |||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | P | ||
| Other (spec.) |
N = new indication. P = previously cleared in K102901
*Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography), Real Time Tissue Elastography
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery. |
| (excludes neurosurgery and laparoscopic procedures). | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, and penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of trans-rectal biopsy. |
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130308 510(k)
Page 7 of 19
Special 510(K)Premarket Notification ~ Noblus™ Ultrasound Diagnostic System
11
Noblus™ System: Transducer: C42K
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Fetal Imaging | ||||||||
| & Other | Abdominal | |||||||
| Intra-operative (Spec.) | Pb | Pb | Pb | Pb | Pb | Pb | ||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication. P = previously cleared in K102901
*Combination of each operating mode, B, M, PWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography)
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery |
| (excludes neurosurgery and laparoscopic procedures). | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, and penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of trans-rectal biopsy. |
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130308 510(k)
Page 8 of 19
Special 510(K)Premarket Notification – Noblus™ Ultrasound Diagnostic System
12
| System: | |
|---|---|
| Transducer: |
Noblus™ EUP-CC531S
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Fetal Imaging | ||||||||
| & Other | Abdominal | |||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | Pe | Pe | Pe | Pe | Pe | Pe | ||
| Trans-vaginal | Pf | Pf | Pf | Pf | Pf | Pf | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication. P = previously cleared in K102901
*Combination of each operating mode, B, M, PWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), Real Time Tissue Elastography
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery |
| (excludes neurosurgery and laparoscopic procedures). | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, and penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For pediatric patients |
| Subscript "h": | Includes imaging for guidance of trans-rectal biopsy. |
rescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130308 510(k)
Page 9 of 19
Special 510(K)Premarket Notification - Noblus™ Ultrasound Diagnostic System
13
Noblus TM System: EUP-054J Transducer:
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | Pb | Pb | Pb | Pb | Pb | Pb | ||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | P | P | ||
| Musculo-skel. (Superfic.) | P | P | P | P | P | P | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | P | |
| Other (spec.) |
N = new indication. P = previously cleared in K102901
*Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography), Real Time Tissue Elastography
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery. |
| (excludes neurosurgery and laparoscopic procedures). | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, and penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For pediatric patients |
| Subscript "h": | Includes imaging for guidance of trans-rectal biopsy. |
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130308 210(K)
Page 10 of 19
Special 510(K)Premarket Notification – Noblus™ Ultrasound Diagnostic System
14
| System: | Noblus TM |
|---|---|
| Transducer: | EUP-OL334 |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Fetal Imaging | ||||||||
| & Other | Abdominal | |||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | P | P | P | P | P | P | ||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
N = new indication. P = previously cleared in K102901
*Combination of each operating mode, B, M, PWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), Real Time Tissue Elastography
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery |
| (excluding neurosurgery and laparoscopic procedures). | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, and penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For pediatric patients |
Includes imaging for guidance of trans-rectal biopsy. Subscript "h"
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130308 210(k)
Page 11 of 19
Special 510(K)Premarket Notification - Noblus™ Ultrasound Diagnostic System
15
System: Noblus™ EUP-R54AW-19, -33 Transducer:
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined* | ||||||||
| (Spec.) | Other** | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Fetal Imaging | |||||||||
| & Other | Abdominal | ||||||||
| Intra-operative (Spec.) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Spec.) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | |||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) |
N = new indication. P = previously cleared in K102901
*Combination of each operating mode, B, M, PWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), Real Time Tissue Elastography
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery |
| (excludes neurosurgery and laparoscopic procedures). | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, and penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For pediatric patients |
| Subscript "h": | Includes imaging for guidance of trans-rectal biopsy. |
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) _K130308
Page 12 of 19
Special 510(K)Premarket Notification ~ Noblus™ Ultrasound Diagnostic System
16
Noblus™ System: Transducer: L34
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Fetal Imaging | ||||||||
| & Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | |
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | P | P | ||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | P | |
| Other (spec.) |
N = new indication. P = previously cleared in K102901
*Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography), Real Time Tissue Elastography
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amnocentesis), Subscript "b": Includes imaging of organs and structures exposed during surgery (excludes neurosurgery and laparoscopic procedures). ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, and penis. |
|---|---|
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For pediatric patients |
| Subscript "h": | Includes imaging for guidance of trans-rectal biopsy |
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130308 510(k)
Page 13 of 19
Special 510(K)Premarket Notification ~ Noblus™ Ultrasound Diagnostic System
17
Noblus™ System: L44 Transducer:
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Fetal Imaging | ||||||||
| & Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | |
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | P | P | ||
| Musculo-skel. (Superfic.) | P | P | P | P | P | P | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | P | |
| Other (spec.) |
N = new indication. P = previously cleared in K102901
*Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography), Real Time Tissue Elastography.
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "b": Includes imaging of organs and structures exposed during surgery
| (excludes neurosurgery and laparoscopic procedures). | |
|---|---|
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, and penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For pediatric patients |
| Subscript "h": | Includes imaging for guidance of trans-rectal biopsy. |
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130308 510(k)
Page 14 of 19
Special 510(K)Premarket Notification – Noblus™ Ultrasound Diagnostic System
18
Noblus TM System: Transducer: ୮୧ର
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Fetal Imaging | ||||||||
| & Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | |
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | P | P | ||
| Musculo-skel. (Superfic.) | P | P | P | P | P | P | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | P | |
| Other (spec.) |
N = new indication. P = previously cleared in K102901
*Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography), Real Time Tissue Elastography.
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery. |
| (excludes neurosurgery and laparoscopic procedures). | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, and penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For pediatric patients |
| Subscript "h": | Includes imaging for guidance of trans-rectal biopsy. |
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130308 510(k)
Page 15 of 19
Special 510(K)Premarket Notification - Noblus™ Ultrasound Diagnostic System
19
Noblus TM System: Transducer: L64
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: | ||
|---|---|---|
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined* | ||||||||
| (Spec.) | Other** | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Fetal Imaging | |||||||||
| & Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | ||
| Intra-operative (Spec.) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | |||
| Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | P | P | P | P | P | P | |||
| Musculo-skel. (Superfic.) | P | P | P | P | P | P | |||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | P | ||
| Other (spec.) |
N = new indication. P = previously cleared in K102901
*Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography), Real Time Tissue Elastography.
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis), Subscript "b": Includes imaging of organs and structures exposed during surgery (excludes neurosurgery and laparoscopic procedures). Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "e": Includes imaging for quidance of trans-rectal biopsy Subscript "f": Includes imaging for guidance of trans-vaginal biopsy. For pediatric patients Subscript "g": Subscript "h": Includes imaging for guidance of trans-rectal biopsy.
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130308 510(k)
Page 16 of 19
Special 510(K)Premarket Notification - Noblus™ Ultrasound Diagnostic System
20
System: Noblus™ Transducer: S21
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended use:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | P | |
| Fetal Imaging | ||||||||
| & Other | Abdominal | P | P | P | P | P | P | P |
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | P | |
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | P | P | P | P | P | P | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | P | P | P | P | P | P | P | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P |
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | P | P |
| Other (spec.) |
N = new indication. P = previously cleared in K102901
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
| Subscript "b": | Includes imaging of organs and structures exposed during surgery.
(excluding neurosurgery and laparoscopic procedures). |
|----------------|----------------------------------------------------------------------------------------------------------------------------|
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, and penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For pediatric patients |
| Subscript "h": | Includes imaging for guidance of trans-rectal biopsy. |
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) -
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130308 510(k)
Page 17 of 19
Special 510(K)Premarket Notification – Noblus™ Ultrasound Diagnostic System
21
System: Noblus™ Transducer: S31
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined* | ||||||||
| (Spec.) | Other** | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Fetal Imaging | Abdominal | P | P | P | P | P | P | P | |
| & Other | Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | ||
| Small Organ (Spec.) | |||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | ||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P | |
| Cardiac Pediatric | P | P | P | P | P | P | P | ||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (spec.) |
N = new indication. P = previously cleared in K102901
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography), Tissue Doppler imaging
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery. |
| (excludes neurosurgery and laparoscopic procedures). | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, and penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For pediatric patients |
| Subscript "h": | Includes imaging for guidance of trans-rectal biopsy. |
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130308 510(k)
Page 18 of 19
Special 510(K)Premarket Notification ~ Noblus™ Ultrasound Diagnostic System
22
Noblus™ System: Transducer: VC34A
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows | NA AN AN ENDER SECTION CONSULTERIAL OR LEAN BERESHIP LEA | SERVICE AND R.E. BANK SECENTRAL LABORATE LE | |
|---|---|---|---|
| Company of the country of the country of the county of the county of |
| Clinical Application | | Mode of Operation | | | | | | Combined*
(Spec.) | Other**
(Spec.) |
|---------------------------|------------------------------|-------------------|---|-----|-----|------------------|---|----------------------|--------------------|
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | | | |
| Ophthalmic | Ophthalmic | P | P | P | | P | P | P | |
| Fetal Imaging
& Other | Fetal | P | P | P | | P | P | P | |
| | Abdominal | P | P | P | | P | P | P | |
| | Intra-operative (Spec.) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | |
| | Small Organ (Spec.) | P | P | P | | P | P | P | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | | |
| | Other (spec.) | | | | | | | | |
N = new indication. P = previously cleared in K102901
*Combination of each operating mode, B, M, PWD and Color Doppler,
** Amplitude Doppler (Color Flow Angiography), 3D Imaging, 4D Imaging
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). |
|---|---|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery. |
| (excluding neurosurgery and laparoscopic procedures). | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, and penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For pediatric patients |
| Subscript "h": | Includes imaging for guidance of trans-rectal biopsy. |
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Port Start
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) K130308
Page 19 of 19
Special 510(K)Premarket Notification - Noblus™ Ultrasound Diagnostic System