(31 days)
Not Found
No
The description focuses on the hardware components and basic control mechanisms (rotary switches, memory settings) of a portable X-ray unit. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies. The performance studies are focused on electrical safety and software validation, not algorithmic performance metrics typically associated with AI/ML.
No
The device is described as an "X-ray unit" intended for "taking diagnostic X-rays," indicating its use for diagnosis rather than treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for taking diagnostic X-rays." Taking diagnostic X-rays is a diagnostic activity.
No
The device description explicitly lists hardware components such as a control panel, X-ray tube, collimator, power cord, and hand switch, indicating it is a physical X-ray unit, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for taking diagnostic X-rays on patients (adult and pediatric). This is an in vivo diagnostic procedure, meaning it's performed on a living organism.
- Device Description: The device is an X-ray unit, which generates radiation to create images of the inside of the body. This is a physical imaging modality, not a test performed on biological samples outside the body.
- IVD Definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue, taken from the human body, to detect diseases, conditions, or infections.
The description clearly indicates the device is used directly on patients for imaging purposes, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
PORTA 100HF is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays.
Product codes
IZL
Device Description
PORTA 100HF is an X-ray unit which operates from AC100-120V/15A or AC200-240V/10A. The device consists of the control panel with the kV and mAs selectors (a rotary switch system) and display for radiographic operations, and the APR switch with 8 memory settings (kV/mAs) to store the exposure data. The device also consists of the X-ray tube, the collimator, power code, and the hand switch, comprising the mono-tank type of a portable X-ray unit. The unit utilizes a high frequency inverter designed to be mounted on a stand. The device can be used with conventional X-ray film or digital imaging media. The usual safety precautions regarding X-rays must be observed by the operator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained physician or technician
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)
Nonclinical Tests for a Determination of Substantial Equivalence: PORTA 100HF has been tested for electrical safety and electromagnetic compatibility (IEC 60601-1-2, CISPR11, IEC 60601-2-7, IEC 60601-2-54, IEC 60601-1-3, IEC 60601-2-28, and IEC 60601-1:2005.) The device also complies with Underwriters Laboratories Standards for Safety (UL2601-1.) The software validation and verification testing was also performed. The results of nonclinical testing indicate that the PORTA 100HF is as safe and effective as the predicate device.
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
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
510(k) Summary
OCT 5 2012
510(k) Submitter:
JOB Corporation 1-19-8 Shinyokohama, Kohoku-ku, Yokohama, Kanagawa, Postal code 222-0033, Japan Tel: 81-45-473-0113 Fax: 81-45-473-0108 Date Prepared: August 16, 2012 Contact: Hiroya Obana, Senior Manager
Trade/Proprietary name: PORTA 100HF
Common/usual name: Portable general purpose diaqnostic X-ray unit Classification name: Mobile X-ray system, Product Code IZL
Equivalent Legally Marketed Device:
This product is similar in function to the Mikasa X-Ray Co., LTD.'s MinXray HF100H+ (K052721.)
Intended Use:
PORTA 100HF is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays.
Description of the Device:
PORTA 100HF is an X-ray unit which operates from AC100-120V/15A or AC200-240V/10A. The device consists of the control panel with the kV and mAs selectors (a rotary switch system) and display for radiographic operations, and the APR switch with 8 memory settings (kV/mAs) to store the exposure data. The device also consists of the X-ray tube, the collimator, power code, and the hand switch, comprising the mono-tank type of a portable X-ray unit. The unit utilizes a high frequency inverter designed to be mounted on a stand. The device can be used with conventional X-ray film or digital imaging media. The usual safety precautions regarding X-rays must be observed by the operator.
Nonclinical Tests for a Determination of Substantial Equivalence:
PORTA 100HF has been tested for electrical safety and electromagnetic compatibility (IEC 60601-1-2, CISPR11, IEC 60601-2-7, IEC 60601-2-54, IEC 60601-1-3, IEC 60601-2-28, and IEC 60601-1:2005.) The device also complies with Underwriters Laboratories Standards for Safety (UL2601-1.) The software validation and verification testing was also performed. The results of nonclinical testing indicate that the PORTA 100HF is as safe and effective as the predicate device.
1
Substantial Equivalence Chart:
.
| Characteristics | (Mikasa X-Ray Co., LTD.)
MinXray HF 100H+
(K052721) | (JOB Corporation)
PORTA 100HF |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended use by a
qualified/technician on both
adult and pediatric subjects
for taking diagnostic X-rays | Same |
| Physical Characteristics | | |
| Size/weight | 406mmx222mmx241mm
18.6Kgs | 160mmx161mmx291mm
9.2Kgs |
| Energy Source
(Input Voltage) | AC100-140V or
AC200-260V | AC100-120V/15A or
AC200-240V/10A |
| Mounting
Method | Unit is usually mounted to
MinXray XGS MKIII portable
stand | Unit is mounted to a
commercially available
portable stand |
| Technical Characteristics | | |
| User Interface | Up-down pushbottons for
kVp selections and
exposure time selections
with LED indicators and
mAs indicators | Up and down Rotary switch
for kV and mAs value with 7
segment LED |
| Exposure times | 0.03-2.00 sec.
0.01 increments | 0.01-2.50 second
32 steps |
| Exposure switch | Dual-stage deadman type | Dual stage, deadman type
with curled cable. |
| Controls | Software based | Software based |
| Construction | Monobloc HF generator,
Medical full bridge inverter
system | Monobloc HF generator,
Medical full bridge inverter
system |
| High Voltage
Adjustment | High frequency (60kHz)
inverter | High frequency inverter |
| Line Voltage
Adjustment | Automatic, dynamic | Automatic, dynamic |
| Tube Potential
(kV) | 40-100kV (2kVstep) | 40-100kV (2kV step). |
| kV step | 31(2kV-step) | 31(2kV-step) |
| Tube current | 30mA (40-60kV)
25mA (62-80kV)
20mA (82-100kV) | 30mA (40-66kV)
20mA (68kV-100kV) |
| X-ray tube | Toshiba D-124S | Toshiba D-124 |
| Anode heat
Storage | 20,000HU | 20,000HU |
| Focal Spot Size | 1.2mm | 1.2mm |
| mAs | 0.6-120mAs | 0.3mAs-50mAs |
| Total Filtration | 3.2mm Al equivalent | 2.5mm Al. eq. at 100kV |
| Collimator | Continuously adjustable (30 sec.) light beam type with
central X-ray indicator | Complete with 30 sec. timer
and cross indication line. |
| Source to Skin
Distance (SSD) | 300mm | 216mm |
| KvP | 100KvP | 100KvP |
| Performance
Standard | 21CFR 1020.30
UL 2601 | 21CFR 1020.30
UL 2601-1 |
| Electrical Safety | IEC 60601-1
IEC 60601-1-2 | IEC 60601-1:2005
IEC 60601-1-3
IEC 60601-2-28
IEC 60601-1-2
CISPR11
IEC 60601-2-7
IEC 60601-2-54 |
| X-ray
Radiography | Conventional X-ray film or
digital imaging media | Conventional X-ray film or
digital imaging media |
.
:
.
.
3
2
Conclusion:
The PORTA 100HF is intended for the same indications for use as the predicate device and the results of the nonclinical testing demonstrate that the PORTA 100HF is as safe and effective as the predicate device. It is the conclusion of JOB Corporation that the PORTA 100HF is as safe and effective as the predicate device and has few technological differences, thus rendering it substantially equivalent to the predicate device.
3
Image /page/3/Picture/0 description: The image shows a logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around a stylized eagle symbol. The eagle is depicted with its wings spread, and its body is formed by three curved lines. The text is in a bold, sans-serif font, and the eagle is in black. The logo is likely used to represent the U.S. Department of Health and Human Services.
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
JOB Corporation
% Mr. Takahiro Haruyama
President
Globizz Corporation
1411 West 190th Street, Suite 120
GARDENA CA 90248
ڪ
Re: K122697
Trade/Device Name: PORTA 100HF Regulation Number: 21 CFR 892.1750 . Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: IZL Dated: August 27, 2012 Received: September 4, 2012
Dear Mr. Haruyama:
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 comply with 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
OCT 5 2012
4
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 Yours.
Michael D'Hara for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
510(k) Number (if known): __
Device Name: PORTA 100HF
Indications for Use:
PORTA 100HF is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
1
Ahn AD Oh
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)_
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