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FDA 510(k)

SPECTRUM X-RAY CORP

K-Number: K834494 · 1984-02-21

ApplicantSpectrum X-Ray Corp.
Decision Date1984-02-21
Product CodeIZZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SPECTRUM X-RAY CORP is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum X-Ray Corp.. It received FDA 510(k) clearance on 1984-02-21 under 510(k) number K834494. The device is classified under product code IZZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRUM X-RAY CORP?

SPECTRUM X-RAY CORP is a medical device that received FDA 510(k) clearance on 1984-02-21. The listed applicant is Spectrum X-Ray Corp.. The 510(k) number is K834494.

When did SPECTRUM X-RAY CORP receive FDA 510(k) clearance?

SPECTRUM X-RAY CORP received FDA 510(k) clearance on 1984-02-21, under 510(k) number K834494.

Who is the listed applicant for SPECTRUM X-RAY CORP?

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

What is the FDA product code for SPECTRUM X-RAY CORP?

The FDA product code for SPECTRUM X-RAY CORP is IZZ.

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 Spectrum 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.

K933134SPECTRUM DG-P7000 PEDIATRIC CRADLEK931563SPECTRUM MARK I SPECIAL PROCEDURES TABLEK870707PENTAMAX 1 MODEL B TABLE SYSTEMK840463DIGITAL CRADLEK827450SIMPLAMATIC IIIK813561SPECTRUM PEDIATRIC CARDLE TABLE

View all 9 devices →

Related Devices (Code: IZZ)

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.

K971452MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLESiemens Medical Solutions USA, Inc.K952701MED-TRON SPECT IMAGING TABLEMed-Tron Products, Inc.K951315CATHETERIZATION TABLE KS-60Shimadzu Medical SystemsK951053ANGIOREX CAT-350BToshiba America Medical Systems, In.CK943926RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLEPhilips Medical Systems (Cleveland), Inc.K930273ALPHARaymax Medical Corp.

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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