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FDA 510(k)

X-RAY GENERATING SYSTEM, TF 800

K-Number: K881387 · 1988-07-08

ApplicantAbsolute X-Ray Corp.
Decision Date1988-07-08
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X-RAY GENERATING SYSTEM, TF 800 is the device name listed in this FDA 510(k) record. The listed applicant is Absolute X-Ray Corp.. It received FDA 510(k) clearance on 1988-07-08 under 510(k) number K881387. 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 800?

X-RAY GENERATING SYSTEM, TF 800 is a medical device that received FDA 510(k) clearance on 1988-07-08. The listed applicant is Absolute X-Ray Corp.. The 510(k) number is K881387.

When did X-RAY GENERATING SYSTEM, TF 800 receive FDA 510(k) clearance?

X-RAY GENERATING SYSTEM, TF 800 received FDA 510(k) clearance on 1988-07-08, under 510(k) number K881387.

Who is the listed applicant for X-RAY GENERATING SYSTEM, TF 800?

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

What is the FDA product code for X-RAY GENERATING SYSTEM, TF 800?

The FDA product code for X-RAY GENERATING SYSTEM, TF 800 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 Absolute 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.

K864042MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SHK854486TABLE,RADIOGRAPHIC-FLUOROSCOPIC,TOMOGRAPHIC,REMOTE

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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