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FDA 510(k)

REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM

K-Number: K992066 · 1999-08-30

ApplicantGE Medical Systems
Decision Date1999-08-30
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 1999-08-30 under 510(k) number K992066. 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 REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM?

REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM is a medical device that received FDA 510(k) clearance on 1999-08-30. The listed applicant is GE Medical Systems. The 510(k) number is K992066.

When did REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM receive FDA 510(k) clearance?

REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM received FDA 510(k) clearance on 1999-08-30, under 510(k) number K992066.

Who is the listed applicant for REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM?

The FDA 510(k) record lists GE Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM?

The FDA product code for REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM is KPR.

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Other records listing GE Medical Systems as applicant

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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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