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FDA 510(k)

TOP-X 650HF RADIOGRAPHIC X-RAY

K-Number: K920347 · 1993-05-17

ApplicantControl-X, Inc.
Decision Date1993-05-17
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TOP-X 650HF RADIOGRAPHIC X-RAY is the device name listed in this FDA 510(k) record. The listed applicant is Control-X, Inc.. It received FDA 510(k) clearance on 1993-05-17 under 510(k) number K920347. 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 TOP-X 650HF RADIOGRAPHIC X-RAY?

TOP-X 650HF RADIOGRAPHIC X-RAY is a medical device that received FDA 510(k) clearance on 1993-05-17. The listed applicant is Control-X, Inc.. The 510(k) number is K920347.

When did TOP-X 650HF RADIOGRAPHIC X-RAY receive FDA 510(k) clearance?

TOP-X 650HF RADIOGRAPHIC X-RAY received FDA 510(k) clearance on 1993-05-17, under 510(k) number K920347.

Who is the listed applicant for TOP-X 650HF RADIOGRAPHIC X-RAY?

The FDA 510(k) record lists Control-X, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOP-X 650HF RADIOGRAPHIC X-RAY?

The FDA product code for TOP-X 650HF RADIOGRAPHIC X-RAY is KPR.

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Other records listing Control-X, 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.

K952265MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATORK924445BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKYK920351PCX 650HF RADIOGRAPHIC X-RAYK920349PCX 1050HF RADIOGRAPHIC X-RAY GENERATORK924443RS-3 UNIVERSAL RADIOGRAPHIC WORKING PLACEK924444B-4 FOUR-WAY RADIOGRAPHIC TABLE

View all 9 devices →

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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