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FDA 510(k)

RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC

K-Number: K982549 · 1998-12-30

ApplicantRadionics, Inc.
Decision Date1998-12-30
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, Inc.. It received FDA 510(k) clearance on 1998-12-30 under 510(k) number K982549. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC?

RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC is a medical device that received FDA 510(k) clearance on 1998-12-30. The listed applicant is Radionics, Inc.. The 510(k) number is K982549.

When did RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC receive FDA 510(k) clearance?

RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC received FDA 510(k) clearance on 1998-12-30, under 510(k) number K982549.

Who is the listed applicant for RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC?

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

What is the FDA product code for RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC?

The FDA product code for RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC is IYE.

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Other records listing Radionics, 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.

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Related Devices (Code: IYE)

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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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