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FDA 510(k)

DI2000/HS-45-150 X-RAY TUBE INSERT

K-Number: K910842 · 1991-03-06

ApplicantComet Ltd. C/O Radiology Resources, Inc.
Decision Date1991-03-06
Product CodeITY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DI2000/HS-45-150 X-RAY TUBE INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Comet Ltd. C/O Radiology Resources, Inc.. It received FDA 510(k) clearance on 1991-03-06 under 510(k) number K910842. The device is classified under product code ITY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DI2000/HS-45-150 X-RAY TUBE INSERT?

DI2000/HS-45-150 X-RAY TUBE INSERT is a medical device that received FDA 510(k) clearance on 1991-03-06. The listed applicant is Comet Ltd. C/O Radiology Resources, Inc.. The 510(k) number is K910842.

When did DI2000/HS-45-150 X-RAY TUBE INSERT receive FDA 510(k) clearance?

DI2000/HS-45-150 X-RAY TUBE INSERT received FDA 510(k) clearance on 1991-03-06, under 510(k) number K910842.

Who is the listed applicant for DI2000/HS-45-150 X-RAY TUBE INSERT?

The FDA 510(k) record lists Comet Ltd. C/O Radiology Resources, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DI2000/HS-45-150 X-RAY TUBE INSERT?

The FDA product code for DI2000/HS-45-150 X-RAY TUBE INSERT is ITY.

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.

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Other records listing Comet Ltd. C/O Radiology Resources, 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.

K912338TUBE HOUSING ASSEMBLIESK911695VARIOUS X-RAY TUBESK901997X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELSK864749TELAMAT

Related Devices (Code: ITY)

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.

K000052X-RAY MONOBLOCK, MONOBLOCK XRS-60-330Dynarad Corp.K933162MRX-750Mrx Corp.K923094MOLYBDENUMSoutheastern Medical Diagnostics, Inc.K923141PHILIPS PRE-FILTER OPTIONPhilips Medical Systems, Inc.K921129MRX-700Mrx-Ray Tube Corp.K921130MRX-865Mrx-Ray Tube 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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