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FDA 510(k)

FACTS MONOBLOCK

K-Number: K981267 · 1998-05-06

ApplicantDynarad Corp.
Decision Date1998-05-06
Product CodeIZX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FACTS MONOBLOCK is the device name listed in this FDA 510(k) record. The listed applicant is Dynarad Corp.. It received FDA 510(k) clearance on 1998-05-06 under 510(k) number K981267. The device is classified under product code IZX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FACTS MONOBLOCK?

FACTS MONOBLOCK is a medical device that received FDA 510(k) clearance on 1998-05-06. The listed applicant is Dynarad Corp.. The 510(k) number is K981267.

When did FACTS MONOBLOCK receive FDA 510(k) clearance?

FACTS MONOBLOCK received FDA 510(k) clearance on 1998-05-06, under 510(k) number K981267.

Who is the listed applicant for FACTS MONOBLOCK?

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

What is the FDA product code for FACTS MONOBLOCK?

The FDA product code for FACTS MONOBLOCK is IZX.

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Other records listing Dynarad 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.

K000052X-RAY MONOBLOCK, MONOBLOCK XRS-60-330K973833CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUALK932356NOVA XM2K941363PHANTOMK932353HF-110AK9323559150A, 1100F

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Related Devices (Code: IZX)

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.

K110856RALCORalco S.R.L.K101036SHIMADZU COLLIMATOR R-20JShimadzu Corp.K042840SHIMADZU COLLIMATOR R-20JShimadzu Corp.K031771SHIMADZU COLLIMATOR R-30HShimadzu Corp.K974240LIGHTLINE-MWuestec Medical, Inc.K972966AXT 150M MANUAL COLLIMATOR (AXT 150M)Applied X-Ray Technologies, 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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