(28 days)
No
The summary describes a portable x-ray unit and its basic operational features. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies. The performance studies focus on safety and effectiveness compared to predicate devices, not on algorithmic performance metrics.
No.
The device is used for taking diagnostic x-rays, which falls under diagnostic imaging, not therapeutic treatment.
Yes
The "Intended Use / Indications for Use" states that the device is "intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays." This explicitly indicates its diagnostic purpose.
No
The device description clearly states it is a "portable unit" that "operates from 120 V 50-60~ AC" and "can be mounted to a tripod or support arm," indicating it is a physical 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 HF100H+™ is an X-ray machine. Its function is to generate X-rays that pass through the body to create an image for diagnostic purposes. This is an in vivo (within the living body) diagnostic method.
- Intended Use: The intended use clearly states it's for "taking diagnostic x-rays," which is a form of medical imaging, not laboratory testing of bodily samples.
Therefore, based on the provided information, the MinXray HF100H+™ is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MinXray HF100H+™ is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.
Product codes
90 IZL
Device Description
MinXray HF100H+1M is a portable unit which operates from 120 V 50-60~ AC. The unit utilizes a newly designed high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of xrays 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
The results of bench and user testing indicates that the new device is as safe and effective as the predicate device.
Key Metrics
Not Found
Predicate Device(s)
MinXray HF100H K973712, MinXray HF120/60H PowerPlus™ K040046
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
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
September 24, 2005 510(k) Summary
1. Identification of the Device: Proprietary-Trade Name: MinXray HF100H+™ High Frequency Diagnostic X-Ray Unit" Classification Name: Mobile X-ray system, Product Code 90 1ZL Common/Usual Name: Portable general purpose diagnostic X-ray Unit.
-
- Indications for Use (intended use) The MinXray HF100H+™ 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: MinXray HF100H+1M is a portable unit which operates from 120 V 50-60~ AC. The unit utilizes a newly designed high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of xrays 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.
| Characteristic | Minxray HF100H
(K973712) | MinXray HF120/60H
(K040046) | MinXray HF100H+
(Modified device) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use : | Intended for use by a
qualified/trained physician
or technician on both adult
and pediatric subjects for
talking diagnostic x-rays. | SAME as HF100H | SAME as HF100H |
| Size/weight | 406 x 222 x 241 mm
18.6kgs | 413 x 224 x 29.2 mm
17.51 kgs | SAME as HF100H |
| Energy Source | 100-140V 50-60 Hz
AC3.0kVA | 100-260V 50-60Hz
AC3.5KVA | SAME as HF100H |
| Characteristic | Minxray HF100H
(K973712) | MinXray HF120/60H
(K040046) | MinXray HF100H+
(Modified device |
| Mounting
method | Unit is usually mounted to
a MinXray XGS MKIII
Portable Stand | SAME as HF100H | SAME as HF100H |
| User Interface | Up-Down pushbuttons for
kVp selections and
exposure time selections
with LED indictors | Up-Down pushbuttons for
kVp selections and
exposure time selections
with LED indictors and
mAs indicators | SAME as HF120/60H |
| Exposure switch | Dual-stage,
deadman type | SAME as HF100H | SAME as HF100H |
| Controls | Analog/digital,
no software | Software based, 2 CPUs. | SAME as HF120/60H |
| Construction | Monobloc HF a
generator, Medical full
bridge inverter system | SAME as HF100H | SAME as HF100H |
| High Voltage
Energy Source | High frequency (60kHz)
inverter | High frequency (40kHz)
inverter | SAME as HF100H |
| Line Voltage
adjustment | Automatic, dynamic | SAME as HF100H | SAME as HF100H |
| Exposure times | (199)(in 0.01 sec. Steps)
0.08 - 4.00 sec | 0.01-0.2 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)
1.0-5.0 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)
1.0-4.0 sec(in 0.1 sec. Steps) |
| Tube potential
(KV) | 40 - 100kV 2kVstep | 40 - 120kV 2kVstep | SAME as HF100H |
| kV steps | 31(2kV-step) | 41(2kV-step) | 31(2kV-step) |
| Tube current
(mA) | 20mA | 60/42mA(40-50kV)
50/35mA(52-60kV)
45/31.5mA(62-70kV)
38/26.6mA(72-80kV)
33/23.1 mA(82-90kV)
30/21 mA(92-100kV)
20/14mA(102-120kV) | 30mA(40-60kV)
25mA(62-80kV)
20mA(82-100kV) |
| mA steps | Constant | 0.01-0.1 sec. (Hi mA)
0.11-5.0 sec. (Low mA) | SAME as HF100H |
| X-ray tube | Toshiba D-124S | SXR-130 Focus x 1.2 | SAME as HF100H |
| Anode heat
Storage | 20,000HU | 65,000HU | SAME as HF100H |
| Focal Spot
Size | 1.2 mm | SAME as HF100H | SAME as HF100H |
| mAs | 1.6-80mAs | 0.6-202mAs | 0.6-120mAs |
| Total filtration | 4.2mm AL equivalent | 3.2mm AL equivalent | SAME as HF120/60H |
| Characteristic | Minxray HF100H
(K973712) | MinXray HF120/60H
(K040046) | MinXray HF100H+
(Modified device) |
| Collimator | Advantech R72
Continuously adjustable
light beam type with
central x-ray indicator | SAME as HF100H | SAME as HF100H |
| Source to Skin
Distance (SSD) | 300 mm | SAME as HF100H | SAME as HF100H |
| Performance
Standard | 21CFR 1020.30 | SAME as HF100H | SAME as HF100H |
| Electrical safety | UL2601, IEC60601-1 | SAME Plus UL listed | SAME as HF100/60H |
-
- Substantial Equivalence Chart, MinXray MinXray HF100H+TM
1
2
7. Conclusion
After analyzing both bench and user testing data, it is the conclusion of MinXray that the MinXray HF100H+™ is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device. Safety is further assured by Underwriters Laboratories testing and listing.
3
Image /page/3/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized emblem that resembles an eagle or bird with three curved lines representing its wings or feathers. The emblem is black, and the text is also in a dark color, likely black or a dark shade of blue.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 2005
MinXray, Inc. % Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015
Re: K052721
Trade/Device Name: MinXray HF100H+™ Regulation Number: 21 CFR 892.1720 Regulation Name: Mobil x-ray system Regulatory Class: II Product Code: IZL Dated: September 24, 2005 Received: September 30, 2005
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 the enorologics to teenay man date of the Medical Device Amendments, or to devices that have been rear 20, 1710, the closedance 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 do not require approval controls provisions of the Act. The general controls provisions of the Act include reguirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If vour 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 FI>A 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.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin manteang your antial equivalence of your device to a legally premarket nothication. The I DA miding or bacements of the may of the 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 th you desire specific advice for your de results.
contact the Office of Compliance at one of the following numbers, based on the regulation number 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 Also, please note the regulation enation on your responsibilities under the Act from the 807.97). Tou may obtain other general more.
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/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
The MinXray HF100H+™ - is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.
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)
David A. Seppam
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ..
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