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FDA 510(k)

NOVA XM2

K-Number: K932356 · 1995-02-08

ApplicantDynarad Corp.
Decision Date1995-02-08
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NOVA XM2 is the device name listed in this FDA 510(k) record. The listed applicant is Dynarad Corp.. It received FDA 510(k) clearance on 1995-02-08 under 510(k) number K932356. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVA XM2?

NOVA XM2 is a medical device that received FDA 510(k) clearance on 1995-02-08. The listed applicant is Dynarad Corp.. The 510(k) number is K932356.

When did NOVA XM2 receive FDA 510(k) clearance?

NOVA XM2 received FDA 510(k) clearance on 1995-02-08, under 510(k) number K932356.

Who is the listed applicant for NOVA XM2?

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 NOVA XM2?

The FDA product code for NOVA XM2 is IZH.

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-60-330K981267FACTS MONOBLOCKK973833CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUALK941363PHANTOMK932353HF-110AK9323559150A, 1100F

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Related Devices (Code: IZH)

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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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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