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FDA 510(k)

CRW-1 SYSTEM

K-Number: K944463 · 1995-10-26

ApplicantRadionics Software Applications, Inc.
Decision Date1995-10-26
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CRW-1 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Radionics Software Applications, Inc.. It received FDA 510(k) clearance on 1995-10-26 under 510(k) number K944463. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRW-1 SYSTEM?

CRW-1 SYSTEM is a medical device that received FDA 510(k) clearance on 1995-10-26. The listed applicant is Radionics Software Applications, Inc.. The 510(k) number is K944463.

When did CRW-1 SYSTEM receive FDA 510(k) clearance?

CRW-1 SYSTEM received FDA 510(k) clearance on 1995-10-26, under 510(k) number K944463.

Who is the listed applicant for CRW-1 SYSTEM?

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

What is the FDA product code for CRW-1 SYSTEM?

The FDA product code for CRW-1 SYSTEM is HAW.

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Other records listing Radionics Software Applications, 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.

K990326OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMIIK974602OPTICAL TRACKING SYSTEM (OTS)K972905XPLAN-1K964801OPTICAL TRACKING SYSTEM (OTS)K961844OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]K962155GILL-THOMAS-COSMAN(GTC) DENTAL TRAY

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Related Devices (Code: HAW)

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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