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FDA 510(k)

CONCEPT ONE

K-Number: K933777 · 1993-12-13

ApplicantInnerscan, Inc.
Decision Date1993-12-13
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CONCEPT ONE is the device name listed in this FDA 510(k) record. The listed applicant is Innerscan, Inc.. It received FDA 510(k) clearance on 1993-12-13 under 510(k) number K933777. The device is classified under product code IZO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONCEPT ONE?

CONCEPT ONE is a medical device that received FDA 510(k) clearance on 1993-12-13. The listed applicant is Innerscan, Inc.. The 510(k) number is K933777.

When did CONCEPT ONE receive FDA 510(k) clearance?

CONCEPT ONE received FDA 510(k) clearance on 1993-12-13, under 510(k) number K933777.

Who is the listed applicant for CONCEPT ONE?

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

What is the FDA product code for CONCEPT ONE?

The FDA product code for CONCEPT ONE is IZO.

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Related Devices (Code: IZO)

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.

K954666MPH50, MPH65, AND MPH80GE Medical SystemsK953582HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATORVarian Canada, Inc.K953831N 800 HFNucletron-Oldelft Corp.K952822SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150GShimadzu Corp.K952265MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATORControl-X, Inc.K950883POLYDOROS SX 65 AND 80Siemens Medical Solutions USA, 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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