(33 days)
No
The summary describes a standard x-ray unit with a high-frequency inverter and does not mention any AI or ML components, image processing, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as an x-ray unit for taking diagnostic x-rays, which generates images for diagnosis rather than directly treating a condition.
Yes.
The "Intended Use / Indications for Use" states that the device is "intended for use... for taking diagnostic x-rays."
No
The device description clearly states it is an "x-ray unit" and mentions hardware components like a "high frequency inverter" and operation from "120 V 50-60~ AC". This indicates it is a hardware device, not software-only.
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 HFP24 and HFP40 is an x-ray unit. It generates radiation that passes through the body to create images for diagnostic purposes. This is an in vivo (within the living body) imaging modality, not an in vitro test.
- Intended Use: The intended use clearly states "taking diagnostic x-rays" and is for "podiatric and extremity applications." This involves imaging the internal structures of the body, not analyzing samples taken from the body.
Therefore, based on the provided information, the MinXray HFP24 and HFP40 is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MinXray HFP24 and HFP40 is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. These units are specifically designed for podiatric and extremity applications.
Product codes
90 IZL
Device Description
MinXray HFP24 and HFP40 are x-ray units which operate from 120 V 50-60~ AC. They utilize a newly designed high frequency inverter designed to be mounted on a stand. The usual safety precautions regarding the use of x-rays must be observed by the operator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
The results of bench and user testing indicates that the new device 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
5 2006 APR
11060566
EXHIBIT 2
Mikasa X-Ray Co., LTD. (Manufacturer) 13-2, Hongo 3-chome Bunkyo-Ku, Tokyo 113-0033 Japan Tel 81-3-3813-3911 Fax 81-3-3813-4420
MinXray, Inc (Initial Distributor) 3611 Commercial Ave. Northbrook, IL 60062 Tel 847-564-0323 Fax 847-564-9040 Contact: Keith Kretchmer
February 25, 2006 510(k) Summary
l . Identification of the Device:
Proprietary-Trade Name: MinXray HFP24 and HFP40 High Frequency Diagnostic X-Ray Units
Classification Name: Mobile X-ray system, Product Code 90 IZL Common/Usual Name: Portable general purpose diagnostic X-ray Unit.
-
- Equivalent legally marketed devices This product is similar in function to the MinXray P200 R24/40 (pre-amendments devices) and MinXray HF100H+ (K052721)
-
- Indications for Use (intended use) The MinXray HFP24 and HFP40 is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. These units are specifically designed for podiatric and extremity applications.
-
- Description of the Device: MinXray HFP24 and HFP40 are x-ray units which operate from 120 V 50-60~ AC. They utilize a newly designed high frequency inverter designed to be mounted on a stand. The usual safety precautions regarding the use of x-rays must be observed by the operator.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate device.
6. Substantial Equivalence Chart, MinXray HFP24 and HFP40
| Characteristic | MinXray P200 R24/40
(pre amendments) | MinXray HF100H+
(K052721) | Minxray HFP24/40
(Modified Device) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use : | Intended for use by a
qualified/trained physician
or technician on both adult
and pediatric subjects for
taking diagnostic x-rays. | SAME | SAME |
| Physical characteristics | | | |
| Size/weight | 171 x 330.2 x 175.5 mm
(P200R24) 13kgs
216 x 330.2 x 190.5 mm
(P200R40) 15kgs | 406 x 222 x 241 mm
18.6kgs | 230 x 195 x 380 mm
(HFP24) 9.3kgs
230 x 195 x 390 mm
(HFP40) 12.5kgs |
| Energy Source | 110-130V 60Hz AC1.0kVA | 100-140V 50-60 Hz 3.0kVA | 100-140V 50-60Hz 1.5kVA |
| Mounting
Method | P200R24 Stationary system
P200R40 Mobile system | Unit is usually mounted to a
MinXray XGS MKIII
Portable Stand | SAME as P200R24/40 |
| Characteristic | MinXray P200 R24/40
(pre amendments) | MinXray HF100H+
(K052721) | Minxray HFP24/40
(Modified Device) |
| | Technical characteristics | | |
| User Interface | Knob for kVp selections
and exposure time
selections | Up-Down pushbuttons for
kVp selections and
exposure time selections
with LED indictors and
mAs indicators | SAME as HF100H+ |
| Exposure switch | Single-stage deadman
type | Dual-stage,
deadman type | SAME as HF100H+ |
| Controls | Analog | Software based, 2 CPUs. | SAME as HF100H+ |
| Construction | Monobloc generator,
Medical high tension
transformer system | Monobloc HF
generator, Medical full
bridge inverter system | SAME as HF100H+ |
| High Voltage
Energy Source | conventional transformer | High frequency (60kHz)
inverter | SAME as HF100H+ |
| Line Voltage
adjustment | manual | Automatic, dynamic | SAME as HF100H+ |
| Exposure times | 0.08-2.0 sec(16 Steps) | 0.03-0.2 sec(in 0.01 sec.
Steps)
0.2-0.4 sec(in 0.02 sec.
Steps)
0.4-1.0 sec(in 0.05 sec.
Steps)
1.0-4.0 sec(in 0.1 sec.
Steps) | 0.03-0.2 sec(in 0.01 sec.
Steps)
0.2-0.4 sec(in 0.02 sec.
Steps)
0.4-1.0 sec(in 0.05 sec.
Steps)
1.0-2.0 sec(in 0.1 sec.
Steps) |
| Tube potential
(KV) | 63kV constant | 40 - 100kV 2kVstep | 50 - 70kV 2kVstep |
| kV steps | constant | 31(2kV-step) | 11(2kV-step) |
| Tube current
(mA) | 12mA | 30mA(40-60kV)
25mA(62-80kV)
20mA(82-100kV) | 10 mA |
| X-ray tube | Toshiba D-102 | Toshiba D-124S | SNMIF XDT-S70 |
| Anode heat
Storage | 20,000 HU | 20,000 HU | 20,000 HU |
| Focal Spot
Size | 1.0 mm | 1.2 mm | 0.8 mm |
| mAs | 0.96-24mAs | 0.6-120mAs | 0.3-20mAs |
| Total filtration | P200R24
2.7 mm AL equivalent
P200R40
3.2 mm AL equivalent | 3.2 mm AL equivalent | SAME as P200 |
| Collimator | P200R24
Advantech R72
P200R40
MIKASA R-200H | Advantech R72
Continuously adjustable
light beam type with
central x-ray indicator | SAME as P200 |
| Source to Skin
Distance (SSD) | P200R24: 24 inches
P200R40: 40 inches | 300 mm | SAME as P200 |
1
7. Conclusion
After analyzing both bench and user testing data, it is the conclusion of MinXray that the MinXray HFP24 and HFP40 High Frequency Diagnostic X-Ray Units are as safe and effective as the predicate devices, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MinXray, Inc. % Daniel Kamm, P.E. Principal Consultant Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015 Re: K060566
5 2006
APR
Trade/Device Name: MinXray HFP24 and HFP40 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: February 25, 2006 Received: March 7, 2006
Dear Mr. Kamm:
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 either class II (Special Controls) or class III (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 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); 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.
3
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation prumber at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industrv/support/index.html.
Sincerely vours.
7 Nancy C. Higdon
Naney C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Ko60566
Device Name: MinXray HFP24 and HFP40
Indications For Use:
The MinXray HFP24 and HFP40 is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. These units are specifically designed for podiatric and extremity applications.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Nancy C hogdon
(Division Sign-Off)
Division of Reproductive, Abd and Radiological Devices 5100k) Number