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FDA 510(k)

MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH

K-Number: K864042 · 1986-10-27

ApplicantAbsolute X-Ray Corp.
Decision Date1986-10-27
Product CodeITY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH is the device name listed in this FDA 510(k) record. The listed applicant is Absolute X-Ray Corp.. It received FDA 510(k) clearance on 1986-10-27 under 510(k) number K864042. 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 MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH?

MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH is a medical device that received FDA 510(k) clearance on 1986-10-27. The listed applicant is Absolute X-Ray Corp.. The 510(k) number is K864042.

When did MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH receive FDA 510(k) clearance?

MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH received FDA 510(k) clearance on 1986-10-27, under 510(k) number K864042.

Who is the listed applicant for MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH?

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

What is the FDA product code for MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH?

The FDA product code for MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH 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.

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 Absolute 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.

K881387X-RAY GENERATING SYSTEM, TF 800K854486TABLE,RADIOGRAPHIC-FLUOROSCOPIC,TOMOGRAPHIC,REMOTE

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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