(71 days)
Not Found
No
The 510(k) summary describes a standard radiographic x-ray system and does not mention any features related to AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is an X-Ray system used for diagnostic imaging (radiographic examinations) and not for treating diseases or conditions.
No.
The device is an x-ray system used to generate images, which are then interpreted by a qualified professional. It does not perform analysis or provide diagnostic output itself.
No
The device description explicitly states it is a "radiographic high frequency stationary x-ray unit" and includes hardware components like a tubestand, radiographic table, and optional wall stand.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This includes things like blood, urine, tissue samples, etc.
- The "HCMI X-Ray" is used to perform radiographic examinations directly on the patient's body. It uses X-rays to create images of internal structures.
The intended use and device description clearly indicate that this is an imaging device used for diagnostic purposes on the patient, not on samples taken from the patient.
N/A
Intended Use / Indications for Use
"HCMI X-Ray" High Frequency 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 (comma separated list FDA assigned to the subject device)
90 KPR
Device Description
The "HCMI X-Ray" is a radiographic high frequency stationary x-ray unit which operates from 120/220 V 50-60~ AC. HCMI X-Ray Systems available: They are always sold with a radiographic table, either elevating or non-elevating. A wall stand with bucky is optional. The FST-10 tubestand is supplied.
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
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.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
OCT 2 2 2002
Image /page/0/Picture/1 description: The image shows a document with the title "510(k) Summary of Safety and Effectiveness". The document includes the logo and contact information for Health Care MFG., INC. The address is listed as 2146 East Pythian St., Springfield, MO 65802. The phone number is 417-864-6511, and the fax number is 417-864-7394. The document also includes the number K022667.
EXHIBIT 2
August 9, 2002 Contact: Katrina Moulder, Official Correspondent
-
- Identification of the Device:
Proprietary-Trade Name: "HCMI X-Ray" High Frequency Radiographic System
- Identification of the Device:
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 to the Bennett X-Ray Radiographic System K952672
-
- Indications for Use (intended use) : "HCMI X-Ray" High Frequency 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 radiographic high frequency stationary x-ray unit which operates from 120/220 V 50-60~ AC. HCMI X-Ray Systems available: They are always sold with a radiographic table, either elevating or non-elevating. A wall stand with bucky is optional. The FST-10 tubestand is supplied.
| 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 |
| HF-3SEE | 25-300 | 40-125 | 30 |
1
-
- 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
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
Standard UL187: UL
Standard for Safety for X-
Ray Equipment. | SAME, |
-
- Substantial Equivalence Chart, "HCMI X-Ray" High Frequency 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 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.
2
Image /page/2/Picture/1 description: The image shows a black and white seal of the Department of Health & Human Services. The seal features a stylized eagle with three lines emanating from its head, representing the department's mission to promote health and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2002
Health Care MFG., Inc. % Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates PO Box 7007 DEERFIELD IL 60015 USA Re: K022667
Trade/Device Name: "HCMI X-Ray" High Frequency Radiographic System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: 90 KPR Dated: August 9, 2002 Received: August 12, 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.
3
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) 594-4591 |
|---|---|
| 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. Snigdon
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
KU22667 510(k) Number
Device Name: "HCMI X-Ray" High Frequency Radiographic System
Indications for Use: "HCMI X-Ray" High Frequency 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. Brogdon
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number -