# K022667: Hcmi X-Ray

- Pathway: 510(k) (Traditional)
- Applicant: Health Care Mfg., Inc.
- Decided: Oct 22, 2002 after 71 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952672 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952672: Vertical Integrated Perfect View (Vip) Radiographic System, Bennett X-Ray Corp. (1995) Summary page 1.

## 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.

Source page: https://510kreport.com/device/K022667
Methodology: https://510kreport.com/methodology