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FDA 510(k)

T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING)

K-Number: K870221 · 1987-05-12

ApplicantKermath Mfg. Corp.
Decision Date1987-05-12
Product CodeKPQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING) is the device name listed in this FDA 510(k) record. The listed applicant is Kermath Mfg. Corp.. It received FDA 510(k) clearance on 1987-05-12 under 510(k) number K870221. The device is classified under product code KPQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING)?

T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING) is a medical device that received FDA 510(k) clearance on 1987-05-12. The listed applicant is Kermath Mfg. Corp.. The 510(k) number is K870221.

When did T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING) receive FDA 510(k) clearance?

T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING) received FDA 510(k) clearance on 1987-05-12, under 510(k) number K870221.

Who is the listed applicant for T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING)?

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

What is the FDA product code for T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING)?

The FDA product code for T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING) is KPQ.

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Other records listing Kermath Mfg. 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.

K812726KERMATH THERAPY SIMULATORK812332KERMATH L/C ARMK811215KERMATH RADIOGRAPHIC HEAD STANDK771549VERSATOME

Related Devices (Code: KPQ)

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.

K132045ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONSGe Hungary KftK101038RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGERAcceletronics Digital Imaging, LLCK090706ONCENTRA SIMULATION 2.3Nucletron CorporationK083591IKOENGELO, VERSION 2Ikoetech, LLCK072445INTEGRATED BRACHYTHERAPY UNIT - DIGITALNucletron Corp.K061006IKOENGELOIkoetech, LLC

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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