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FDA 510(k)

XRT 400

K-Number: K955414 · 1996-07-24

ApplicantWuestec Medical, Inc.
Decision Date1996-07-24
Product CodeKXJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XRT 400 is the device name listed in this FDA 510(k) record. The listed applicant is Wuestec Medical, Inc.. It received FDA 510(k) clearance on 1996-07-24 under 510(k) number K955414. The device is classified under product code KXJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XRT 400?

XRT 400 is a medical device that received FDA 510(k) clearance on 1996-07-24. The listed applicant is Wuestec Medical, Inc.. The 510(k) number is K955414.

When did XRT 400 receive FDA 510(k) clearance?

XRT 400 received FDA 510(k) clearance on 1996-07-24, under 510(k) number K955414.

Who is the listed applicant for XRT 400?

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

What is the FDA product code for XRT 400?

The FDA product code for XRT 400 is KXJ.

Other records listing Wuestec Medical, 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.

K993962PENSIL TRAUMA, MODEL WWS6100K992603XRT 600 R/F, WRF 0600K992103C-QUESTK981880DX-480, ADD ON DIGITAL IMAGERK974240LIGHTLINE-MK960083MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300

View all 9 devices →

Related Devices (Code: KXJ)

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.

K050190APOLLOVilla Sistemi Medicali S.P.A.K963905RADIOGRAPHIC ITT TABLEX-Ray Technologies, Inc.K951146IMAGING TABLESepta Corp.K950068CARBON FIBER COUCH INSERTMedtec, Inc.K950442INFRARED EXPOSURE HAND SWITCHMedical X-Ray Intl., Inc.K940696SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5Philips Medical Systems North America, 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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