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FDA 510(k)

X-RAY GENERATING SYSTEM TF 1000

K-Number: K881386 · 1988-07-08

ApplicantGeneral Medical Merate S.P.A
Decision Date1988-07-08
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X-RAY GENERATING SYSTEM TF 1000 is the device name listed in this FDA 510(k) record. The listed applicant is General Medical Merate S.P.A. It received FDA 510(k) clearance on 1988-07-08 under 510(k) number K881386. The device is classified under product code IZO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-RAY GENERATING SYSTEM TF 1000?

X-RAY GENERATING SYSTEM TF 1000 is a medical device that received FDA 510(k) clearance on 1988-07-08. The listed applicant is General Medical Merate S.P.A. The 510(k) number is K881386.

When did X-RAY GENERATING SYSTEM TF 1000 receive FDA 510(k) clearance?

X-RAY GENERATING SYSTEM TF 1000 received FDA 510(k) clearance on 1988-07-08, under 510(k) number K881386.

Who is the listed applicant for X-RAY GENERATING SYSTEM TF 1000?

The FDA 510(k) record lists General Medical Merate S.P.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-RAY GENERATING SYSTEM TF 1000?

The FDA product code for X-RAY GENERATING SYSTEM TF 1000 is IZO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing General Medical Merate S.P.A 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.

K213081CLISIS SYSTEMS, Discovery RF180K173395MECALL CLISIS SYSTEMS, Discovery RF180K082243PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMSK041605PRECISION RXI ANALOG X-RAY SYSTEMK827993MTH C/A MOBILE C ARM

Related Devices (Code: IZO)

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.

K954666MPH50, MPH65, AND MPH80GE Medical SystemsK953582HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATORVarian Canada, Inc.K953831N 800 HFNucletron-Oldelft Corp.K952822SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150GShimadzu Corp.K952265MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATORControl-X, Inc.K950883POLYDOROS SX 65 AND 80Siemens Medical Solutions USA, Inc.

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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