(64 days)
No
The summary describes a standard radiographic system with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
No
The device is described as a radiographic system used for examination and imaging, not for treating conditions.
Yes
The device is used to perform general purpose radiographic examinations, which aids in the diagnosis of conditions by visualizing internal body structures.
No
The device description clearly outlines hardware components including a high voltage generator, control panel, tube stand, tube head, collimator, and optional table and wall stand. This indicates it is a hardware-based medical device, 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 clearly states that the device is for performing general purpose radiographic examinations of various body parts. This involves imaging the internal structures of the body using X-rays.
- Device Description: The description details a chiropractic radiographic high frequency stationary x-ray unit, including components like a high voltage generator, control panel, tube stand, and collimator. These are all components of an X-ray imaging system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) in vitro (outside the body). IVDs are designed to analyze these types of samples to provide information about a person's health.
Therefore, the "HCMI X-Ray" High Frequency Chiropractic Radiographic System is a medical imaging device, specifically an X-ray system, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"HCMI X-Ray" High Frequency Chiropractic Radiographic System is intended for use by a qualified/trained doctor or technician or both to perform general purpose radiographic examinations of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in the prone or supine position.
Product codes
90 KPR
Device Description
The "HCMI X-Ray" is a chiropractic radiographic high frequency stationary x-ray unit which operates from 120/220 V 50-60~ AC. The standard system includes the high voltage generator, control panel, a Model S-82RM Tube Stand, and HC-172-F wall mount cassette holder. The tube stand employs a Toshiba tube head and a certified Eureka collimator. A radiographic table, one of several models, is optional. A wall stand with bucky is optional.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified/trained doctor or technician or both
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 devices.
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
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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OCT 2 2 2002
EXHIBIT 2 510(k) Summary of Safety and Effectiveness
Image /page/0/Picture/2 description: The image shows the logo and contact information for Health Care MFG., INC. The address is 2146 East Pythian St., Springfield, MO 65802. The phone number is 417-864-6511, and the fax number is 417-864-7394.
KC22737
August 9, 2002 Contact: Katrina Moulder, Official Correspondent
-
- Identification of the Device: Proprietary-Trade Name: "HCMI X-Ray" High Frequency Chiropractic Radiographic System Classification Name: Stationary X-Ray System, Product Code 90 KPR Common/Usual Name: Stationary X-Ray System
- Equivalent legally marketed devices This product is similar in function and 2. design to the Bennett X-Ray Radiographic System K952672
-
- Indications for Use (intended use) : "HCMI X-Ray" High Frequency Chiropractic Radiographic System is intended for use by a qualified/trained doctor or technician or both to perform general purpose radiographic examinations of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in the prone or supine position
- Description of the Device: The "HCMI X-Ray" is a chiropractic radiographic 4. high frequency stationary x-ray unit which operates from 120/220 V 50-60~ AC. The standard system includes the high voltage generator, control panel, a Model S-82RM Tube Stand, and HC-172-F wall mount cassette holder. The tube stand employs a Toshiba tube head and a certified Eureka collimator. A radiographic table, one of several models, is optional. A wall stand with bucky is optional.
HCMI 100 kHz Generators with Anatomical Programming:
| Model | mA Range | kVp Range | Max KW |
|---|---|---|---|
| HF-300 | 25-300 | 40-125 | 30 |
| HF-600 | 25-600 | 40-125 | 37.5 |
| HF-3SE | 25-300 | 40-125 | 30 |
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-
- 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 devices.
| Characteristic | Bennett X-Ray
Radiographic System
K952672 | "HCMI X-Ray"
High Frequency
Chiropractic
Radiographic
System |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Intended Use: | Intended for use by a
qualified/trained doctor or
technician on both adult and
pediatric subjects for taking
diagnostic radiographic
exposures of the skull, spinal
column, chest, abdomen,
extremities, and other body
parts. Applications can be
performed with the patient
sitting, standing, or lying in
the prone or supine position. | SAME |
| Performance
Standard | 21 CFR 1020.30 | SAME |
| Electrical safety | Electrical Safety per
Underwriters Laboratories
Standard UL-2601(IEC-
60601) and IEC 60601,
Underwriters Laboratories | SAME, plus tested for
EMC compatibility |
-
- Substantial Equivalence Chart, "HCMI X-Ray" High Frequency Chiropractic Radiographic System
7. Conclusion
After analyzing bench, electrical safety, EMC, and user testing data, it is the conclusion of Health Care Manufacturing, Inc. that the "HCMI X-Ray" High Frequency Chiropractic Radiographic System 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Health Care Mfg., Inc. % Mr. Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015 Re: K022737
Trade/Device Name: "HCMI X-Ray" High Frequency Chiropractic Radiographic System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: 90 KPR Dated: August 14, 2002 Received: August 19, 2002
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 (PMA), it may be subject to 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,
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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 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-459 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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
4
j) Indications for Use
510(k) Number K (222
Device Name: "HCMI X-Ray" High Frequency Chiropractic Radiographic System
Indications for Use: "HCMI X-Ray" High Frequency Chiropractic Radiographic System is intended for use by a qualified/trained doctor or technician or both to perform general purpose radiographic examinations of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in the prone or supine position.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over the Counter Use (Per 21 CFR 801.109)
Nancy C. Hodgdon
(Division Sign-Off) Dession of Reproductive, Abdominal, are Padiological Devices 5 : (k) Number _______________________________________________________________________________________________________________________________________________________________
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