(72 days)
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric, Small Organ (breast. testes. thyroid); Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult & pediatric); Peripheral Vascular (PV); and Urology (including prostate).
E-CUBE 15 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 18.5" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
The provided document is a 510(k) summary for the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE 15 ultrasonic imaging system. It primarily details the device's substantial equivalence to a predicate device and its compliance with safety and performance standards.
Based on the provided information, here's an analysis of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific acceptance criteria (e.g., numerical thresholds for accuracy, sensitivity, specificity) for the E-CUBE 15's imaging performance. Instead, the "Summary of Non-Clinical Tests" and "Summary of Clinical Tests" sections indicate the following as the basis for device performance and safety:
| Acceptance Criterion Type | Details Provided in Document |
|---|---|
| Safety and Performance Standards Conformance | The device has been evaluated for biocompatibility, acoustic output, and thermal, electrical, electromagnetic, and mechanical safety. It conforms to applicable medical device safety standards and voluntary standards (NEMA UD2, UD3, AIUM Medical Ultrasound Safety, IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-2-37, ISO 10993-1). Transducer materials and other patient contact materials are biocompatible. |
| Substantial Equivalence to Predicate Device | The E-CUBE 15 employs the "same fundamental scientific technology" as its predicate device (K120060 E-CUBE 9 Diagnostic Ultrasound System). The conclusion explicitly states it is "as safe, as effective, and performance is substantially equivalent to the predicate device." |
2. Sample Sizes Used for the Test Set and Data Provenance
The document explicitly states: "The subject of this premarket submission, E-CUBE 15, did not require clinical studies to support substantial equivalence."
Therefore, there is:
- No test set sample size reported as no clinical studies were performed.
- No data provenance (country of origin, retrospective/prospective) because no clinical data was collected for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical studies were conducted for the E-CUBE 15 to establish performance against a test set, there is no information provided regarding:
- The number of experts.
- The qualifications of those experts.
4. Adjudication Method for the Test Set
As no clinical studies were conducted involving expert interpretation of a test set, there is no adjudication method mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
The document states that "The subject of this premarket submission, E-CUBE 15, did not require clinical studies to support substantial equivalence." Therefore, no MRMC comparative effectiveness study was done, and thus no effect size of human readers improving with AI vs. without AI assistance is reported. (Note: AI is not explicitly mentioned as a component of this device, which is an ultrasonic imaging system.)
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This device is an ultrasonic imaging system. The submission focuses on its hardware and software for image acquisition and display, and its equivalence to a predicate device. It is not an AI/algorithm-only device, so a standalone algorithm performance study is not applicable and not reported. The "performance" assessment is based on compliance with safety standards and fundamental scientific equivalence to the predicate device.
7. The Type of Ground Truth Used
Given that no clinical studies were performed to evaluate the diagnostic performance of the device itself (only to affirm substantial equivalence to a predicate), no specific ground truth (expert consensus, pathology, outcomes data, etc.) was used for this submission's approval. The "truth" for this submission is based on the predicate device's established performance and the E-CUBE 15's compliance with engineering and safety standards.
8. The Sample Size for the Training Set
The document does not describe any machine learning or AI components that would require a "training set." Therefore, no sample size for a training set is reported.
9. How the Ground Truth for the Training Set was Established
Since there is no mention of a training set, no information is provided on how its ground truth would have been established.
Summary of Device Approval Approach:
The approval for the E-CUBE 15 appears to be based on the substantial equivalence pathway. This means the manufacturer demonstrated that the E-CUBE 15 is as safe and effective as a legally marketed predicate device (E-CUBE 9, K120060) and complies with relevant performance and safety standards. For this type of submission (ultrasound imaging system, not a novel diagnostic algorithm), extensive new clinical performance data or studies directly comparing its diagnostic accuracy to ground truth are often not required if substantial equivalence can be demonstrated through technical and non-clinical testing, and comparison with a predicate.
{0}------------------------------------------------
K123610
510(k) E-CUBE 15
FEB 0 1 2013
F-1
510(k) Summary
In accordance with 21CFR807.92, the following summary.of information is provided;
Nov 16" 2012 Date
Submitter: ALPINION MEDICAL SYSTEMS Co., Ltd. Address: 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu, Seoul, Republic of Korea 152-848,
Primary Contact Person
Donghwan Kim' QARA Manager Address: 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu, Seoul, Republic of Korea 152-848, Phone: +82 70 7465 2068 Fax: +82 2 851 5590 Email: donghwan.kim@alpinion.com
| Secondary Contact | |
|---|---|
| Person |
Yuchi Chu Address: Suite 229, 10604 NE 38th Place, Kirkland, WA 98033, United States Phone: 425 949 4907 Fax: 425 949 4908 Email: ychu@alpinionus.com
Device Trade Name: E-CUBE 15
Common/Usual Name: Ultrasonic Pulsed Doppler Imaging System:
Classification Names System, Imaging, Pulsed Doppler Ultrasonic
Product Code:
Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550 90-IYN . Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO
Diagnostic Ultrasound Transducer, 21CFR 892.1570, 90-ITX
K120060 E-CUBE 9 Diagnostic Ultrasound System Predicate Device(s)
{1}------------------------------------------------
Device Description:
E-CUBE 15 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 18.5" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
Indications For Use:
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric, Small Organ (breast. testes. thyroid); Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult & pediatric); Peripheral Vascular (PV); and Urology (including prostate).
Technology: E-CUBE 15 employs the same fundamental scientific technology as its predicate device. :.
Summary of Non-Clinical Tests:
Determination of Substantial Equivalence:
E-CUBE 15 has been evaluated for biocompatibility, acoustic output as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. E-CUBE 15 and its application comply with voluntary standards as detailed in this premarket submission. The following quality management system measures were applied to the development of E-CUBE 15:
- ◆ NEMA UD2, UD3
- AIUM Medical Ultrasound Safety
- IEC60601-1
- IEC60601-1-1
- IEC60601-1-2
- IEC60601-2-37
- ISO 10993-1
Transducer materials and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, E-CUBE 15, did not require clinical studies to support substantial equivalence.
Conclusion:
Alpinion Medical Systems Co., Ltd. considers E-CUBE 15 to be as safe, as effective, and performance is substantially equivalent to the predicate device.
F-2
ALPINION MEDICAL SYSTEMS Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA or the requirements will be published in guidance documents.
{2}------------------------------------------------
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
February 1, 2013
Alpinion Medical Systems, Co., Ltd. c/o Mr. Donghwan Kim QARA Manager 1,6 and 7FL, Verti Tower, 72, Digital-ro(St) 26-gil (Rd) Guro-gu Seoul, 152-848 KOREA REPUBLIC
Re: K123610
Trade/Device Name: E-CUBE 15 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: November 21, 2012 Received: November 21, 2012
Dear Mr. Kim
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the E-CUBE 15, as described in your premarket notification:
Transducer Model Number
| SC1-6H | SVC1-6 |
|---|---|
| L3-12H | L3-12X |
| SP1-5X | L3-8 |
| L8-17X | SP3-8 |
| SC1-4H | CW 2.0 |
| E3-10H | CW 5.0 |
{3}------------------------------------------------
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
If you have any questions regarding the content of this letter, please contact Joshua Nipper at (301) 796-6524.
Sincerely Yours,
Sean M. Boyd - S
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: E-CUBE 15
Indications for Use:
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric, Small Organ (breast, testes, thyroid); Trans-rectal, Trans-vaginal, Musculo-skeletal(Conventional); Musculoskeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vascular (PV); and Urology (including prostate).
Prescription Use_ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR
(Part 21 CFR 807 Subpart C)
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Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
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Olvision of Radiologic
Office of in Vitro Ulagnostics a
510(k) K123610
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Diagnostic Ultrasound Indications for Use
E-CUBE 15 Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color Doppler | Power Doppler | Tissue Harmonic Imaging | Combined* (Specify) | Other** (Specify) | ||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | P | N | ||
| Abdominal | P | P | P | P | P | P | P | N | ||
| Intra-operative (Specify) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | N | N | N | ||
| Small Organ(breast, testes, thyroid) | P | P | P | P | P | P | P | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | P | P | P | P | P | P | P | |||
| Trans-vaginal | P | P | P | P | P | P | P | |||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | P | |||
| Musculo-skeletal(Superficial) | P | P | P | P | P | P | P | |||
| Intravascular | ||||||||||
| Cardiac Adult | P | P | P | P | P | P | P | P | ||
| Cardiac Pediatric | N | N | N | N | N | N | N | N | ||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | P | |||
| Urology (including prostate) | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K121888; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-VitrPMagn89f18 Bevices (OIVD)
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
Prescription User (Per 21 CFR 801.109)
51000 K123610
{6}------------------------------------------------
Diagnostic Ultrasound Indications for Use
E-CUBE 15 with SC1-6H Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | P | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | ||
| Small Organ(breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | P | P | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDAK121888; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVP)
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Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health Prescription User (Per 21 CFR 801.109)
{7}------------------------------------------------
Diagnostic Ultrasound Indications for Use
E-CUBE 15 with L3-12H Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | ||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative (Specify) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ(breast, testes, thyroid) | P | P | P | P | P | P | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | ||||
| Musculo-skeletal(Superficial) | P | P | P | P | P | P | ||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | ||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K120060; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
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Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
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Division of Radiological Health
Prescription User (Per 21 CFR 801.109)
Office of In Vitro Diagnostics and Radiological Health
TO Diagnosed and Treatment Program, Patient
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{8}------------------------------------------------
Diagnostic Ultrasound Indications for Use
E-CUBE 15 with SP1-5X Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | P | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | ||
| Small Organ(breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | P | P | P | P | P | P | P | P | |
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K121888; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
(Division Sign Off)
Division of Radiological Health
Prescription User (Per 21 CFR 801.109)
Office of In Vitro Diagnostics and Radiological Hosetth
ALPINION MEDICAL SYSTEMS Co., LEGORI
{9}------------------------------------------------
Diagnostic Ultrasound Indications for Use
E-CUBE 15 with L8-17X Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | ||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative (Specify) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ | P | P | P | P | P | P | ||||
| (breast, testes, thyroid) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | P | P | P | P | P | P | ||||
| Musculo-skeletal | P | P | ||||||||
| (Superficial) | P | P | P | P | P | |||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) ' | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | ||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K121888; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
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Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
| Prescription User (Per 21 CFR 801.109) | |
|---|---|
| ---------------------------------------- | -- |
(Division Sign Off)
Division of Radiological Health
Office of State Procurement
| ALPINION MEDICAL SYSTEMS Co., Ltd. |
|---|
| 510(k) |
E-6
{10}------------------------------------------------
Diagnostic Ultrasound Indications for Use
E-CUBE 15 with SC1-4H Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Combined*(Specify) | Other**(Specify) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | |||
| Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | P | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | ||
| Small Organ(breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K121888; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
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Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
Thision Sign C
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Division of Radiological Health
ALPINION MEDICAL SYSTEMS Co., Ltd. Million of In Vitto Dlagnostics and Radiological Health
点11
{11}------------------------------------------------
Diagnostic Uitrasound Indications for Use
E-CUBE 15 with E3-10H Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | Tissue HarmonicImaging | Combined*(Specify) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ(breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | P | ||
| Trans-vaginal | P | P | P | P | P | P | P | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K121888; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
(Division Sign Off)
Division of Radiological Health
ALPINION MEDICAL SYSTEMS Co., Ltd.
510(k) K123610
. E-8
{12}------------------------------------------------
Diagnostic Ultrasound Indications for Use
E-CUBE 15 with SVC1-6 Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | P | P | |
| Abdominal | P | P | P | P | P | P | P | P | |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) . | |||||||||
| Laparoscopic. | |||||||||
| Pediatric | P | P | P | P | P | P | P | P | |
| Small Organ(breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | P | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K120060; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
(Division Sign Off) .
Division of Radiological Heatth
Diagnostics and Radiological Health ALPINION MEDICAL SYSTEMS Co., Ltd. 510k
E-d
{13}------------------------------------------------
Diagnostic Ultrasound Indications for Use
E-CUBE 15 L3-12X with Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Other**(Specify) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | |||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative (Specify) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | N | N | |||
| Small Organ | N | N | N | N | N | N | N | |||
| (breast, testes, thyroid) | ||||||||||
| · Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | N | N | N | N | N | N | N | |||
| (Conventional) | ||||||||||
| Musculo-skeletal | N | N | N | N | N | N | N | |||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral vessel | N | N | N | N | N | N | N | |||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA ; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
(Division Sign Off)
Prescription User (Per 21 CFR 801.109)
Division of Radiological Health Office of In Vitro Disanostics and Radiological Health
E-10
{14}------------------------------------------------
Diagnostic Ultrasound Indications for Use
E-CUBE 15 L3-8 with Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | ||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative (Specify) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | ||||
| Small Organ | P | P | P | P | P | P | ||||
| (breast, testes, thyroid) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | P | P | P | P | P | P | ||||
| (Conventional) | ||||||||||
| Musculo-skeletal | P | P | P | P | P | P | ||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | ||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K120060; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
(Division's Sign Off)
Division of Radiological Health
ALPINION MEDICAL SYSTEMS Co., Ltd.Office of In Vitro Diagnostics and Radiological Health
{15}------------------------------------------------
Diagnostic Ultrasound Indications for Use
E-CUBE 15 with SP3-8 Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other **(Specify) | ||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P. | P | P | |||
| Intra-operative (Specify) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | P | |||
| Small Organ | ||||||||||
| (breast, testes, thyroid) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | P | P | P | P | P | P | P | P | ||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral vessel | ||||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K120060; E = added under appendix
510(k)
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitto Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
Division Sign Off Division of Radiological Health
- Lack of clear vision and/or poorly defined product backlog.
{16}------------------------------------------------
Diagnostic Ultrasound Indications for Use
E-CUBE 15 with CW 2.0 Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | |||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intra-operative (Specify) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | |||||||||||
| Small Organ(breast, testes, thyroid) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal(Conventional) | |||||||||||
| Musculo-skeletal(Superficial) | |||||||||||
| Intravascular | |||||||||||
| Cardiac Adult | N | ||||||||||
| Cardiac Pediatric | N | ||||||||||
| Intravascular (Cardiac) | |||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Peripheral vessel | |||||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vityo Diagnostic Devices (OIVD)
ಕೆಗಾಗಿ
| Prescription User (Per 21 CFR 801.109) |
|---|
| ---------------------------------------- |
(Division Sign Off) Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health ALPINION MEDICAL SYSTEMS Co., Ltd
E-13
{17}------------------------------------------------
Diagnostic Ultrasound Indications for Use
E-CUBE 15 with CW 5.0 Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ(breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | N | ||||||||
| Cardiac Pediatric | N | ||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnøstic Devices (OIVD)
51000
(Division Sign On)
Prescription User (Per 21 CFR 801 109)
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
Ltd.
§ 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.