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FDA 510(k)

OLYMP-X,X-RAY GENERATOR

K-Number: K925684 · 1993-02-02

ApplicantAfp Imaging Corp.
Decision Date1993-02-02
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OLYMP-X,X-RAY GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Afp Imaging Corp.. It received FDA 510(k) clearance on 1993-02-02 under 510(k) number K925684. 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 OLYMP-X,X-RAY GENERATOR?

OLYMP-X,X-RAY GENERATOR is a medical device that received FDA 510(k) clearance on 1993-02-02. The listed applicant is Afp Imaging Corp.. The 510(k) number is K925684.

When did OLYMP-X,X-RAY GENERATOR receive FDA 510(k) clearance?

OLYMP-X,X-RAY GENERATOR received FDA 510(k) clearance on 1993-02-02, under 510(k) number K925684.

Who is the listed applicant for OLYMP-X,X-RAY GENERATOR?

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

What is the FDA product code for OLYMP-X,X-RAY GENERATOR?

The FDA product code for OLYMP-X,X-RAY GENERATOR is IZO.

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Other records listing Afp Imaging 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.

K123419EVA SELECT DIGITAL DENTAL IMAGING SYSTEMK072357NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEMK041120EV APAN DIGITAL, MODEL K1VSM2000K030647EVA DIGITAL DENTAL X-RAY SYSTEMK014144EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804K013176MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE

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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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