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FDA 510(k)

MULTIPLE ED1600 SERIES RADIATION SHIELDS

K-Number: K944772 · 1994-10-20

ApplicantImage Diagnostics, Inc.
Decision Date1994-10-20
Product CodeEAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MULTIPLE ED1600 SERIES RADIATION SHIELDS is the device name listed in this FDA 510(k) record. The listed applicant is Image Diagnostics, Inc.. It received FDA 510(k) clearance on 1994-10-20 under 510(k) number K944772. The device is classified under product code EAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTIPLE ED1600 SERIES RADIATION SHIELDS?

MULTIPLE ED1600 SERIES RADIATION SHIELDS is a medical device that received FDA 510(k) clearance on 1994-10-20. The listed applicant is Image Diagnostics, Inc.. The 510(k) number is K944772.

When did MULTIPLE ED1600 SERIES RADIATION SHIELDS receive FDA 510(k) clearance?

MULTIPLE ED1600 SERIES RADIATION SHIELDS received FDA 510(k) clearance on 1994-10-20, under 510(k) number K944772.

Who is the listed applicant for MULTIPLE ED1600 SERIES RADIATION SHIELDS?

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

What is the FDA product code for MULTIPLE ED1600 SERIES RADIATION SHIELDS?

The FDA product code for MULTIPLE ED1600 SERIES RADIATION SHIELDS is EAK.

Related Clinical Trials

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Other records listing Image Diagnostics, 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.

K950631ID400 SERIES ARMBOARDSK942190ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE

Related Devices (Code: EAK)

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.

K952233CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628Victoreen, Inc.K944445ED CORP RADIATION SCREENMed Corp.K896949MOBILE X-RAY PERSONNEL PROTECTIVE SCREENSInnovative Products Mfg.K861019CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELDPhase One Disign Co.K850816LEAD PLASTIC VIEWING PANELSVictoreen, Inc.K850814MODULAR X-RAY BARRIERSVictoreen, 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.

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