FDA 510(k)

OHMICRON MAMMOGRAPHY X-RAY SYSTEM MODEL OMC 4520M

K-Number: K828619 · 1983-01-03

Decision Date1983-01-03

Product Code

DecisionSubstantially Equivalent

Device Summary

OHMICRON MAMMOGRAPHY X-RAY SYSTEM MODEL OMC 4520M is the device name listed in this FDA 510(k) record. The listed applicant is Ohmic , Ltd.. It received FDA 510(k) clearance on 1983-01-03 under 510(k) number K828619. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OHMICRON MAMMOGRAPHY X-RAY SYSTEM MODEL OMC 4520M?

OHMICRON MAMMOGRAPHY X-RAY SYSTEM MODEL OMC 4520M is a medical device that received FDA 510(k) clearance on 1983-01-03. The listed applicant is Ohmic , Ltd.. The 510(k) number is K828619.

When did OHMICRON MAMMOGRAPHY X-RAY SYSTEM MODEL OMC 4520M receive FDA 510(k) clearance?

OHMICRON MAMMOGRAPHY X-RAY SYSTEM MODEL OMC 4520M received FDA 510(k) clearance on 1983-01-03, under 510(k) number K828619.

Who is the listed applicant for OHMICRON MAMMOGRAPHY X-RAY SYSTEM MODEL OMC 4520M?

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

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.