FDA 510(k)

CT 5221 DOSE REDUCING COLLIMATORS

K-Number: K780736 · 1978-06-02

Decision Date1978-06-02

Product CodeIZX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CT 5221 DOSE REDUCING COLLIMATORS is the device name listed in this FDA 510(k) record. The listed applicant is Emi Medical, Inc.. It received FDA 510(k) clearance on 1978-06-02 under 510(k) number K780736. 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 CT 5221 DOSE REDUCING COLLIMATORS?

CT 5221 DOSE REDUCING COLLIMATORS is a medical device that received FDA 510(k) clearance on 1978-06-02. The listed applicant is Emi Medical, Inc.. The 510(k) number is K780736.

When did CT 5221 DOSE REDUCING COLLIMATORS receive FDA 510(k) clearance?

CT 5221 DOSE REDUCING COLLIMATORS received FDA 510(k) clearance on 1978-06-02, under 510(k) number K780736.

Who is the listed applicant for CT 5221 DOSE REDUCING COLLIMATORS?

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

What is the FDA product code for CT 5221 DOSE REDUCING COLLIMATORS?

The FDA product code for CT 5221 DOSE REDUCING COLLIMATORS is IZX.

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Other records listing Emi Medical, Inc. as applicant

K791429EMISONIC 4290 K781936SCANNER-EMI 7020 AND 7020R K781519EMI SIMULATOR REMOTE CONTROL CONSOLE K781051EMISONIC 4201 K780995COMPUTERIZED AXIAL TOMOGRAPHY K7809305543 INDEPENDENT VIEWING SYSTEM

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Related Devices (Code: IZX)

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.