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FDA 510(k)

HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR

K-Number: K953582 · 1995-09-26

ApplicantVarian Canada, Inc.
Decision Date1995-09-26
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Varian Canada, Inc.. It received FDA 510(k) clearance on 1995-09-26 under 510(k) number K953582. 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 HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR?

HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR is a medical device that received FDA 510(k) clearance on 1995-09-26. The listed applicant is Varian Canada, Inc.. The 510(k) number is K953582.

When did HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR receive FDA 510(k) clearance?

HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR received FDA 510(k) clearance on 1995-09-26, under 510(k) number K953582.

Who is the listed applicant for HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR?

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

What is the FDA product code for HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR?

The FDA product code for HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR is IZO.

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Other records listing Varian Canada, 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.

K923455HFG 350, 650, 1050K920938VJW2919 PNEUMATIC COMPRESSION UPGRADEK913234VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLYK910820VPW 2877E6 X-RAY POWER SUPPLYK904169VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLYK905855VPW2877E7 X RAY POWER SUPPLY

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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 SystemsK953831N 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.K950694COMPACT-XElectromed Intl., Ltd.

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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