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FDA 510(k)

FUTURUS 2001 X-RAY GENERATOR

K-Number: K902637 · 1990-08-03

ApplicantAcoma Medical Imaging, Inc.
Decision Date1990-08-03
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FUTURUS 2001 X-RAY GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Acoma Medical Imaging, Inc.. It received FDA 510(k) clearance on 1990-08-03 under 510(k) number K902637. 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 FUTURUS 2001 X-RAY GENERATOR?

FUTURUS 2001 X-RAY GENERATOR is a medical device that received FDA 510(k) clearance on 1990-08-03. The listed applicant is Acoma Medical Imaging, Inc.. The 510(k) number is K902637.

When did FUTURUS 2001 X-RAY GENERATOR receive FDA 510(k) clearance?

FUTURUS 2001 X-RAY GENERATOR received FDA 510(k) clearance on 1990-08-03, under 510(k) number K902637.

Who is the listed applicant for FUTURUS 2001 X-RAY GENERATOR?

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

What is the FDA product code for FUTURUS 2001 X-RAY GENERATOR?

The FDA product code for FUTURUS 2001 X-RAY GENERATOR is IZO.

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Other records listing Acoma Medical Imaging, Inc. as applicant

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K981227SYMPHONY 360 REMOTE CONTROL TABLEK981131PATHFINDER MOBILE C ARMK963851TILTING RADIOGRAPHIC TABLE (REMOTE)K944952ANGIOGRAPHIC SYSTEMK941004CTS SYSTEMK941017F/C/W TUBESTAND

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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

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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