(74 days)
Not Found
No
The summary describes a standard X-ray unit with operator-controlled settings and does not mention any AI or ML components or functions.
No
The device is described as a diagnostic medical radiography unit, which is used for imaging and not for treating or preventing diseases.
Yes
The "Intended Use / Indications for Use" section explicitly states "general purpose diagnostic medical radiography" and "diagnostic radiographic applications."
No
The device description clearly states it is an X-ray unit consisting of control, X-ray generator, and beam limiting device, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The MinXray HF100H is an X-ray unit. It generates X-rays that pass through the patient's body to create an image. This is a form of in vivo diagnostic imaging, meaning it is performed within the living body.
- Intended Use: The intended use clearly states "portable and mobile general purpose diagnostic medical radiography." This involves taking images of the internal structures of the body, not analyzing samples taken from the body.
Therefore, based on the provided information, the MinXray HF100H is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MinXray HF100H will be initially marketed for portable and mobile general purpose diagnostic medical radiography. Because of its compact size and high output to weight ratio, we anticipate that the initial uses will be in field, home care, and nursing home diagnostic radiographic applicatons. These uses are typical of the predicate device, the MinXray HF80H. We believe that the safety and effectiveness of the two models are substantially equivalent.
Experience in the market with the HF100H may make us aware of other possible applications. This unit may be eventually married with stands for permanent or semi-permanent installation for intra-operative use, hand and/or foot radiography, or other medical diagnostic applications. MinXray will make some stands available as accessory items for use with the HF100H. Other manufacturers may make stands compatible with various portable X-ray units, and we anticipate that some end users will purchase a MinXray HF100H to be used with some other stand of their choice.
Product codes
90 IZL
Device Description
The MinXray HF100H is a compact, self-contained high frequency X-ray unit consisting of the control, X-ray generator, and beam limiting device. Tube voltage (KV) and exposure time are variable and selected by the operator. Tube current is fixed at 20 mA.
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
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Preproduction testing showed that radiographs of the same patient produced on either device were essentially identical.
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.
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Image /page/0/Picture/0 description: The image shows the logo for MINXRAY INC. The logo is in black and white and features the company name in a bold, stylized font. The letters are closely spaced and slightly overlapping, creating a sense of unity and strength. The "INC" is smaller and placed to the right of the main name.
EXHIBIT A
510(k) Summary of Safety and Effectiveness
DEC 1 2 1997
Identification of the Device 1.
Classification Name: 90 IZL per 21 CFR 892.1720
Common/Usual Name: Portable general purpose diagnostic X-ray unit.
Proprietary Trade Name: MinXray HF100H High Frequency Diagnostic X-ray Unit
Equivalent legally marketed device 2.
This product is similar in design and function to the MinXray HF80H High Frequency Diagnostic X-ray Unit (K945707).
3. Indications for Use (intended use)
The MinXray HF100H will be initially marketed for portable and mobile general purpose diagnostic medical radiography. Because of its compact size and high output to weight ratio, we anticipate that the initial uses will be in field, home care, and nursing home diagnostic radiographic applicatons. These uses are typical of the predicate device, the MinXray HF80H. We believe that the safety and effectiveness of the two models are substantially equivalent.
Experience in the market with the HF100H may make us aware of other possible This unit may be eventually married with stands for permanent or applications. semi-permanent installation for intra-operative use, hand and/or foot radiography, or other medical diagnostic applications. MinXray will make some stands available as accessory items for use with the HF100H. Other manufacturers may make stands compatible with various portable X-ray units, and we anticipate that some end users will purchase a MinXray HF100H to be used with some other stand of their choice.
Description of the device 4.
The MinXray HF100H is a compact, self-contained high frequency X-ray unit consisting of the control, X-ray generator, and beam limiting device. Tube voltage (KV) and exposure time are variable and selected by the operator. Tube current is fixed at 20 mA.
Safety and Effectiveness, comparison to predicate device 5.
The MinXray HF100H is substantially equivalent to the MinXray HF80H in safety and effectiveness. Preproduction testing showed that radiographs of the same patient produced on either device were essentially identical. The following chart compares the new and predicate devices.
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Image /page/1/Picture/0 description: The image shows the logo for MINXRAY Inc. The logo is in black and white and features a stylized font. The letters are bold and slightly overlapping.
6. Substantial Equivalence Chart
| Feature | MinXray HF100H (new device) | MinXray HF80H (predicate) |
|---|---|---|
| X-ray output | 20 mA @ 40-100 kV | |
| in 2 kV steps | 10 mA @ 50-80 kV | |
| in 5 kV steps | ||
| Timer | 0.08-2.00 sec. | |
| 192 steps | 0.08-3.98 sec. | |
| 195 steps | ||
| X-ray generator | Constant potential, 60 kHz | |
| Full-wave rectified | Constant potential, 45 kHz | |
| Full-wave rectified | ||
| Line voltage adjustment | Automatic, dynamic | Automatic, dynamic |
| X-ray tube | Toshiba D-124K or equiv. | Toshiba D-102 or equiv. |
| Focal spot size | 1.2 mm | 1.0 mm |
| Total filtration | 3.2 mm Al equivalent | 3.2 mm Al equivalent |
| Collimator | Advantech R-70ET or equiv. | Advantech R-70ET or equiv. |
| Exposure cord | 8 feet (2.44 meters) | 8 feet (2.44 meters) |
| Exposure switch | Two-stage, deadman type | Two-stage, deadman type |
| Power cord | 10 feet (3.05 meters) | 10 feet (3.05 meters) |
| Overload protection | Thermal, built-in | Thermal, built-in |
| Size (tubehead/control) | 9.5" (24.1 cm) W, | |
| 8.75" (22.2 cm) H, | ||
| 15.35" (39 cm) L |
- skin guards | 6.5" (16.5 cm) W,
7.5" (19 cm) H,
14.5" (27.94 cm) L - skin guards |
| Weight | 40.9 lbs (18.6 kgs) | 27.5 lbs (12.5 kgs) |
| Control display | Digital | Digital |
7. Conclusion
Since there are no new indications for use, nor are there any new potential hazards, and preproduction testing showed that radiographs of the same patient produced on either device were essentially identical, MinXray is of the opinion that the devices are substantially equivalent.
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Image /page/2/Picture/0 description: The image shows the logo for MINXRAY INC. The logo is in black and white and features the company name in a bold, sans-serif font. The "X" in MINXRAY is stylized with the left side of the X being thicker than the right side. The letters "INC" are smaller and located to the right of the word MINXRAY.
Manufacturer's Statement of Substantial Equivalence 8.
STATEMENT OF INDICATIONS FOR USE:
The MinXray HF100H will be initially marketed for portable and mobile general purpose diagnostic medical radiography. These uses are typical of the predicate device, the MinXray HF80H.
CLAIMS REGARDING DEVICE FEATURES, PERFORMANCE, OR SAFETY:
This product is similar in design and function to the MinXray HF80H high frequency diagnostic X-ray unit (K945707).
This notification contains all of the information required by 21 CFR 807.87. A completed copy of the "DRAERD Premarket Notification 510(k) Screening Checklist" is attached.
The subject device conforms to the following mandatory standards:
Performance Standard: 21 CFR 1020.30 Diagnostic X-ray Systems
The subject device has the same technological characteristics as a legally marketed predicate device. Specifically, the features, specifications, materials, and mode of action are equivalent. If the subject device is a kit, all of the contents of the kit are either pre-Amendment devices or have been cleared for marketing through previous 510(k)s. The kit contains no drug or biologic product.
The subject device is not software controlled.
TRUTHFUL AND ACCURATE STATEMENT (as required by 21 CFR 807.87(j)):
I certify that, in my capacity as President of MinXray, Inc., I believe, to the best of my knowledge, that the above statements and all data and information submitted in this premarket notification are truthful and accurate and that no material fact has been omitted.
Keith R. Krettenhir
Keith R. Kretchmer President
4/26/97
Data
Date
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2 1997
Keith R. Kretchmer President MinXRay, Inc. 3611 Commercial Avenue Northbrook, IL 60062-1822 Re: K973712 MinXray HF100H High Frequency Diagnostic X-Ray Unit Dated: December 5, 1997 Received: December 8, 1997 Regulatory Class: II 21 CFR 892.1720/Procode: 90 IZL
Dear Mr. Kretchmer:
We have reviewed your Section 510(k) 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 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.
If your device is classified (see above) into either class II (Premarket Approval), 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 Part 80) and additionally 809.10 for in vitr' diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639- Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
W.Liau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for MINXRAY INC. The logo is in black and white and features the company name in a bold, sans-serif font. The "X" in MINXRAY is stylized with the left side of the "X" being thicker than the right side. The "INC" is in a smaller font size and is located to the right of the word "MINXRAY".
EXHIBIT B
Indications for Use (intended use)
The MinXray HF100H will be initially marketed for portable and mobile general purpose diagnostic medical radiography. Because of its compact size and high output to weight ratio, we anticipate that the initial uses will be in field, home care, and nursing home diagnostic radiographic applicatons. These uses are typical of the predicate device, the diagnotic rational depice that the safety and effectiveness of the two models are substantially equivalent.
Experience in the market with the HF100H may make us aware of other possible This unit may be eventually married with stands for permanent or applications. semi-permanent installation for intra-operative use, hand and/or foot radiography, or other medical diagnostic applications. MinXray will make some stands available as accessory items for use the HF100H. Other manufacturers may make stands compatible with various portable X-ray units, and we anticipate that some end users will purchase a MinXray HF100H to be used with some other stand of their choice.
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)