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FDA 510(k)

MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM

K-Number: K926407 · 1993-03-31

ApplicantNucletron-Oldelft Corp.
Decision Date1993-03-31
Product CodeKXJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron-Oldelft Corp.. It received FDA 510(k) clearance on 1993-03-31 under 510(k) number K926407. 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 MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM?

MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM is a medical device that received FDA 510(k) clearance on 1993-03-31. The listed applicant is Nucletron-Oldelft Corp.. The 510(k) number is K926407.

When did MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM receive FDA 510(k) clearance?

MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM received FDA 510(k) clearance on 1993-03-31, under 510(k) number K926407.

Who is the listed applicant for MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM?

The FDA 510(k) record lists Nucletron-Oldelft Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM?

The FDA product code for MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM is KXJ.

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Other records listing Nucletron-Oldelft Corp. 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.

K953946MICROSELECTRON-HDR VERSION 2K953831N 800 HFK925956MICROSELECTRON - HDR FOR MOBILE ENVIRONMENTK921991PLATO RADIATION THERAPY PLANNING SYSTEMK915622PLATO BRACHYTHERAPHY TREATMENT PLANNING SYSTEMK911612NUCLETRON PLANNING SYSTEM

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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.K955414XRT 400Wuestec Medical, Inc.K951146IMAGING TABLESepta Corp.K950068CARBON FIBER COUCH INSERTMedtec, Inc.K950442INFRARED EXPOSURE HAND SWITCHMedical X-Ray Intl., 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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