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FDA 510(k)

AXT 150M MANUAL COLLIMATOR (AXT 150M)

K-Number: K972966 · 1997-08-21

ApplicantApplied X-Ray Technologies, Inc.
Decision Date1997-08-21
Product CodeIZX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AXT 150M MANUAL COLLIMATOR (AXT 150M) is the device name listed in this FDA 510(k) record. The listed applicant is Applied X-Ray Technologies, Inc.. It received FDA 510(k) clearance on 1997-08-21 under 510(k) number K972966. 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 AXT 150M MANUAL COLLIMATOR (AXT 150M)?

AXT 150M MANUAL COLLIMATOR (AXT 150M) is a medical device that received FDA 510(k) clearance on 1997-08-21. The listed applicant is Applied X-Ray Technologies, Inc.. The 510(k) number is K972966.

When did AXT 150M MANUAL COLLIMATOR (AXT 150M) receive FDA 510(k) clearance?

AXT 150M MANUAL COLLIMATOR (AXT 150M) received FDA 510(k) clearance on 1997-08-21, under 510(k) number K972966.

Who is the listed applicant for AXT 150M MANUAL COLLIMATOR (AXT 150M)?

The FDA 510(k) record lists Applied X-Ray Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AXT 150M MANUAL COLLIMATOR (AXT 150M)?

The FDA product code for AXT 150M MANUAL COLLIMATOR (AXT 150M) is IZX.

Related Clinical Trials

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Other records listing Applied X-Ray Technologies, 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.

K942367AXT 1400 SPOTFILM DEVICEK882492A.X.T. SPOTFILM DEVICE

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.K981267FACTS MONOBLOCKDynarad Corp.K974240LIGHTLINE-MWuestec Medical, 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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