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FDA 510(k)

DCX-100 CHEST UNIT-GL-5000M

K-Number: K841923 · 1984-08-10

ApplicantTransworld X-Ray Corp.
Decision Date1984-08-10
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DCX-100 CHEST UNIT-GL-5000M is the device name listed in this FDA 510(k) record. The listed applicant is Transworld X-Ray Corp.. It received FDA 510(k) clearance on 1984-08-10 under 510(k) number K841923. 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 DCX-100 CHEST UNIT-GL-5000M?

DCX-100 CHEST UNIT-GL-5000M is a medical device that received FDA 510(k) clearance on 1984-08-10. The listed applicant is Transworld X-Ray Corp.. The 510(k) number is K841923.

When did DCX-100 CHEST UNIT-GL-5000M receive FDA 510(k) clearance?

DCX-100 CHEST UNIT-GL-5000M received FDA 510(k) clearance on 1984-08-10, under 510(k) number K841923.

Who is the listed applicant for DCX-100 CHEST UNIT-GL-5000M?

The FDA 510(k) record lists Transworld X-Ray Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DCX-100 CHEST UNIT-GL-5000M?

The FDA product code for DCX-100 CHEST UNIT-GL-5000M is KPR.

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Other records listing Transworld X-Ray Corp. 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.

K892657SENSIMATK890066STAR 36K873283MODEL C2-5000 OVERHEAD TUBE SUPPORTK872980MAM-CP X-RAY APPARATUSK872357TRANSWORLD 360V, MODEL A1-4040K827582MODIFIED X-RAY TABLE

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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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