(100 days)
K#052587
K#052587
No
The summary describes standard image processing and reconstruction techniques for CT imaging and does not mention AI or ML.
No
The device is described as an "x-ray imaging device" used for diagnostic support by acquiring and displaying images. It does not perform any therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that applications include "diagnosis for Temporal, Nasal, Orbita, Maxilla, Mandibula, Cerviales, Cranium and Basicranium area" and that the device is for "use in diagnostic support."
No
The device description explicitly states it "consists of rotation arm part, main body part, base part and accessories including personal computer and software," indicating it includes significant hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device is an imaging device: The description clearly states that the MCT-1EX-1F8/F17 is an "x-ray imaging device" that acquires images of the head and neck areas. It uses a cone-shaped x-ray beam and a flat panel detector.
- The intended use is for diagnostic support through imaging: The device is used to create 3D reconstructions and 2D views of anatomical structures for diagnostic support, not to analyze biological samples.
Therefore, the MCT-1EX-1F8/F17 falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
MCT-1EX-1F8/F17 is intended to be used for head and neck three dimensional X-ray Computed Tomography by a limited, cone-shaped x-ray beam projected onto a flat panel X-ray detector, to be operated and used by doctors, dentists, properly licensed professionals and other legally qualified professionals.
Applications include diagnosis for Temporal, Nasal, Orbita, Maxilla, Mandibula, Cerviales, Cranium and Basicranium area.
The Model MCT-1EX-1F8/F17 is a x-ray imaging device that acquires a 360 degree rotational sequence of the head and neck areas, including the ENT and dento maxillofacial areas, for use in diagnostic support. The device accomplishes this task by reconstructing a three dimensional matrix of the examined volume and producing two dimensional views of this volume, displaying both two and three-dimensional images.
Product codes
JAK
Device Description
The MCT-1EX-1F8/F17 is an x-ray imaging device that acquires 360 degree rotational sequence of the head and neck areas, mainly for dentistry. The imaging data are once stored at three dimensional matrix of the examined volume, and are reconstructed by image processing through the Personal Computer, then finally displayed as both two and three dimensional images on the monitor.
It consists of rotation arm part, main body part, base part and accessories including personal computer and software.
This MCT-1EX-1F8/F17 is a slightly modified device from the MCT-1EXF ( K#052587) of J.MORITA MFG. CORP replacing the solid state x-ray imaging device of "Flat Panel Detector (FPD)" with some other additional modifications.
As the main hardware and software are used common, this new MCT-IEX-1F8/F1F reserves the same general intended use, similar principles of operation, and similar technological characteristics as the predicate device MCT-1EXF. It is selfexplanatory that the MCT-1EX-1F8/F17 is substantially equivalent to MCT-1EXF.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray imaging device
Anatomical Site
head and neck areas, Temporal, Nasal, Orbita, Maxilla, Mandibula, Cerviales, Cranium and Basicranium area, ENT and dento maxillofacial areas
Indicated Patient Age Range
Not Found
Intended User / Care Setting
doctors, dentists, properly licensed professionals and other legally qualified professionals, physicians, dentists and x ray technologists.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. 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
APR - 9 2008
:
510(k) SUMMARY J. Morita USA Inc.'s 3D Accu-I-tomo XYZ Slice view Tomograph Model : MCT-1EX-1F8/F17
1. Submitter Name and Address with Phone/Fax :
| Registration No. 2081055 | Registration No. 3002807636 |
|---|---|
| Initial Distributor: | Manufacturer: |
| J. Morita USA, Inc. | J. MORITA MFG. CORP. |
| 9 Mason | 680 Higashihama Minami-cho |
| Irvine, CA 92618 | Fushimi-ku, Kyoto |
| USA | Japan 612-8533 |
| Telephone: 949-581-9600 | +81-75-611-2141 |
| Facsimile: 949-581-9688 | +81-75-605-2353 |
2. Contact Person
Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. Suite 1 100 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331
3. Date summary prepared: January 24, 2008
whose details are shown in Table-A below.
···
-
- Device Name:
Trade or Proprietary Name: 3D Accu-I-tomo XYZ Slice view tomograph Model: MCT-1EX-1F8/F17 Note: The name is abbreviated to MCT-1EX-1F8/F17 in the 510(k) submission , and includes two kinds of actual models, MCT-1EX-1F8 and MCT-1EX-1F17
- Device Name:
| Common Name: | Cone beam x-ray CT |
|---|---|
| Classification Name: | Computed tomography x-ray system |
| (21CFR892.1750) | |
| Product Code: | JAK |
1
| Division | Actual model number | Main differences | ||
|---|---|---|---|---|
| Size of | ||||
| radiographic | ||||
| area size | ||||
| D x H (mm) | FPD used | Rotation | ||
| arm | ||||
| This | ||||
| submission | MCT-1EX-1F8 | 40x40 | ||
| 60x60 | ||||
| 80x80 | Made by | |||
| Hamamatsu | Linear- | |||
| shaped- | ||||
| C-arm | ||||
| MCT-1 EX-1F17 | Note-1 | Made by | ||
| Varian | ||||
| The | ||||
| predicate | MCT-1EXF | 40x40 | ||
| 60x60 | Made by | |||
| Hamamatsu | Round-shaped | |||
| C-arm |
| The MCT-1EX-1F8/F17 includes the actual model numbers specified with the main | |
|---|---|
| differences as shown in Table-A below. |
Note-1: Selectable between 170 x 120mm and 40 x 40mm. (Diameter x Height)
Table-A Actual model numbers in MCT-1EX-1F8/F17
5. Substantial Equivalency is claimed against the following devices:
3D Accu-I-tomo XYZ Slice View Tomograph MCT-1EXF (K052587)
6. Description of the device:
The MCT-1EX-1F8/F17 is an x-ray imaging device that acquires 360 degree rotational sequence of the head and neck areas, mainly for dentistry. The imaging data are once stored at three dimensional matrix of the examined volume, and are reconstructed by image processing through the Personal Computer, then finally displayed as both two and three dimensional images on the monitor.
It consists of rotation arm part, main body part, base part and accessories including personal computer and software.
This MCT-1EX-1F8/F17 is a slightly modified device from the MCT-1EXF ( K#052587) of J.MORITA MFG. CORP replacing the solid state x-ray imaging device of "Flat Panel Detector (FPD)" with some other additional modifications.
As the main hardware and software are used common, this new MCT-IEX-1F8/F17reserves the same general intended use, similar principles of operation, and similar technological characteristics as the predicate device MCT-1EXF. It is selfexplanatory that the MCT-1EX-1F8/F17 is substantially equivalent to MCT-1EXF.
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2
7. Intended Use
Intended use
MCT-1EX-1F8/F17 is intended to be used for head and neck three dimensional X-ray Computed Tomography by a limited, cone-shaped x-ray beam projected onto a flat panel X-ray detector, to be operated and used by doctors, dentists, properly licensed professionals and other legally qualified professionals.
Applications include diagnosis for Temporal, Nasal, Orbita, Maxilla, Mandibula, Cerviales, Cranium and Basicranium area.
8. Safety and effectiveness of the device
SUBSTANTIAL EQUIVALENCE
The MCT-1EX-1F8/F17 covered by this submission is developed from our legally marketed device, MCT-1EXF (K#052587), modified slightly by replacing FPD to enlarge the radiographic area by using larger field of FPD, without any significant changes for the other components or performances. The comparison including the differences are described at the Table-1 titled " Comparison chart: MCT-1EX-1F8/F17 to MCT-1EXF" at Attachment 5 of this submission.
As is shown in the following comparison summary chart and table , MCT-1EX-1F8/F17 is substantially equivalent to MCT-1EXF because they have similar general intended uses, technological characteristics and operating principles. As described above, any differences in the technological characteristics do not raise any new issues of safety or effectiveness.
| This new submission | Predicate device | Difference | |
|---|---|---|---|
| Name of | |||
| model | MCT-1EX-1F8/F17 | MCT-1EXF | Different |
| Manufacturer | J.MORITA | ||
| MFG. CORP. | J.MORITA | ||
| MFG. CORP. | Identical | ||
| Construction | 1)Slightly modified | ||
| Rotating arm |
- The same conventional
base/chair/support tower | 1)Conventional
Rotating arm
2)Conventional
base/chair/support tower | Similar |
| Image
Receptor | Flat panel detecter | Flat panel detecter | Same |
| Performance
spec. | International standards | International standards | Similar |
| Mechanical | Morita made mechanism | Morita made mechanism | Similar |
| Electrical | Morita made electric circuit | Morita made electric circuit | Similar |
| Software | Morita made software | Morita made software | Slightly
Different |
| Testing | Mainly done by VDE | Mainly done by VDE | Same |
Table-1 Comparison summary chart
40
3
Table-2 Comparison summary table
FDA file reference number
Attachment inside notification submission file 510k FDA website print out.
| TECHNOLOGICAL CHARACTERISTICS | Comparison result | |
|---|---|---|
| Model name of Predicate Device | MCT-1EXF | |
| 510(k) number of Predicate Device | K052587 | |
| Indication for use | Identical | |
| Target population | Similar | |
| Design | Slightly changed | Note-1 |
| Materials | Slightly changed | Note-2 |
| Performance | Slightly changed | Note-3 |
| Sterility | Similar | |
| Biocompatibility | Similar | |
| Mechanical safety | Similar | |
| Chemical safety | Similar | |
| Anatomical sites | Similar | |
| Human factors | Similar | |
| Energy used and/or delivered | Similar | |
| Compatibility with environment and other devices | Similar | |
| Where used | Identical | |
| Standards met | Identical | |
| Electrical safety | Identical | |
| Thermal safety | Identical | |
| Radiation safety | Identical |
Note- l
This new devices are designed to enlarge the sizes of radiographic areas, so that some modifications are done over the arm assembly, FPD and software or else Note-2
The new larger size FPD is introduced.
Note-3
The enlarged sizes of radiographic areas are obtained with higher image quality such as high speed, high fidelity or high resolution other than standard mode.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
MAY 20 2010
J. Morita USA. Inc. % Mr. Keith A. Barritt, Attorney Fish & Richardson P.C. 1425 K St. N.W., Suite 1100 WASHINGTON DC 20005
Re: K073695
Trade/Device Name: 3D Accu-I-tomo Slice View Tomograph, Model MCT-1EX-1F8/F17 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 24, 2008 Received: March 25, 2008
Dear Mr. Barritt:
This letter corrects our substantially equivalent letter of April 9, 2008.
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), 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 or mry vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
5
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.
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 Diagnostic Device Evaluation and Safety 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 vours.
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(K) Number : unknown
Device Name: 3D Accu-I-tomo XYZ Slice view tomograph, Model: MCT-1EX-1F8/F17
Indications for Use:
The Model MCT-1EX-1F8/F17 is a x-ray imaging device that acquires a 360 degree rotational sequence of the head and neck areas, including the ENT and dento maxillofacial areas, for use in diagnostic support. The device accomplishes this task by reconstructing a three dimensional matrix of the examined volume and producing two dimensional views of this volume, displaying both twor and threedimensional images.
The device is operated and used by physicians, dentists and x ray technologists.
Prescription Use
(Par2! CFR801 Subpert D)
AND/OR
Over-The-Counter Use (Part21 CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation(ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(K) Number :
Prescription Use (Part21CFR801.109)
or
Over-The-Counter Use (Optional Format 1-2-96)
hozi K. Wtz
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices No73695 510(k) Number