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FDA 510(k)

RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM

K-Number: K934519 · 1993-12-13

ApplicantMedtec, Inc.
Decision Date1993-12-13
Product CodeIWE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtec, Inc.. It received FDA 510(k) clearance on 1993-12-13 under 510(k) number K934519. The device is classified under product code IWE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM?

RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM is a medical device that received FDA 510(k) clearance on 1993-12-13. The listed applicant is Medtec, Inc.. The 510(k) number is K934519.

When did RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM receive FDA 510(k) clearance?

RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM received FDA 510(k) clearance on 1993-12-13, under 510(k) number K934519.

Who is the listed applicant for RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM?

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

What is the FDA product code for RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM?

The FDA product code for RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM is IWE.

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Other records listing Medtec, 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.

K111340HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEMK093738MRI PATIENT POSITIONING DEVICESK974703CARBON FIBER BREAST BOARDK974700MATRIX MT-MX3K973842CARBON FIBER CONFORMAL COUCH TOPK962622INTRA-ORAL THERMOPLASTIC SHIELD

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Related Devices (Code: IWE)

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.

K973162DUAL RADIATION TARGETING SYSTEM DRTS DRAPEHogan & HartsonK955236GREEN TEC-2100Medtec, Inc.K954414CENTRALITE BACKPOINTERDiacor, Inc.K950293TEC-2110 GREEN LASER MODEL MT-HNGMedtec, Inc.K950112CENTRALITE(R)-DLL SERIESDiacor, Inc.K951601MED-TEC STRING RETICLE TRAYMedtec, 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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