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FDA 510(k)

REI-90/15

K-Number: K853175 · 1985-10-10

ApplicantRadiological Engineering, Inc.
Decision Date1985-10-10
Product CodeIXR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

REI-90/15 is the device name listed in this FDA 510(k) record. The listed applicant is Radiological Engineering, Inc.. It received FDA 510(k) clearance on 1985-10-10 under 510(k) number K853175. The device is classified under product code IXR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REI-90/15?

REI-90/15 is a medical device that received FDA 510(k) clearance on 1985-10-10. The listed applicant is Radiological Engineering, Inc.. The 510(k) number is K853175.

When did REI-90/15 receive FDA 510(k) clearance?

REI-90/15 received FDA 510(k) clearance on 1985-10-10, under 510(k) number K853175.

Who is the listed applicant for REI-90/15?

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

What is the FDA product code for REI-90/15?

The FDA product code for REI-90/15 is IXR.

Other records listing Radiological Engineering, 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.

K873702REI-38 RADIOGRAPHIC TABLEK854478REI-90/90 RADIOGRAPHIC TABLEK853210MST-1050-II X-RAY UNIT

Related Devices (Code: IXR)

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.

K000412VISION R/F TILTING TABLEVilla Sistemi Medicali S.P.A.K973039LEGACY/LEGACY-D TABLEGE Medical SystemsK971128CAP-35B III/CINE 275Jamieson Film Co.K970640PHILIPS EASY DIAGNOSTPhilips Medical Systems North America, Inc.K965105ELECTROPHYSIOLOGY TILT TABLE MODEL #9660U.S. Imaging Tables, Inc.K965096FLUOROVIEW SERIES FLUOROSCOPIC TABLESU.S. Imaging Tables, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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