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FDA 510(k)

HCMI X-RAY

K-Number: K022667 · 2002-10-22

ApplicantHealth Care Mfg., Inc.
Decision Date2002-10-22
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HCMI X-RAY is the device name listed in this FDA 510(k) record. The listed applicant is Health Care Mfg., Inc.. It received FDA 510(k) clearance on 2002-10-22 under 510(k) number K022667. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HCMI X-RAY?

HCMI X-RAY is a medical device that received FDA 510(k) clearance on 2002-10-22. The listed applicant is Health Care Mfg., Inc.. The 510(k) number is K022667.

When did HCMI X-RAY receive FDA 510(k) clearance?

HCMI X-RAY received FDA 510(k) clearance on 2002-10-22, under 510(k) number K022667.

Who is the listed applicant for HCMI X-RAY?

The FDA 510(k) record lists Health Care Mfg., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HCMI X-RAY?

The FDA product code for HCMI X-RAY is KPR.

Other records listing Health Care Mfg., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K022737HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHICK952441LEGENDK951323VH-2000K951382HLT 406K944699ATT-300K944329BACK SPECIALIST

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Related Devices (Code: KPR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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