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FDA 510(k)

MODIFIED X-RAY CONTROLS, MODEL ED125L AND ED150L

K-Number: K881886 · 1988-08-04

ApplicantU.S. Imaging, Inc.
Decision Date1988-08-04
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFIED X-RAY CONTROLS, MODEL ED125L AND ED150L is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Imaging, Inc.. It received FDA 510(k) clearance on 1988-08-04 under 510(k) number K881886. 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 MODIFIED X-RAY CONTROLS, MODEL ED125L AND ED150L?

MODIFIED X-RAY CONTROLS, MODEL ED125L AND ED150L is a medical device that received FDA 510(k) clearance on 1988-08-04. The listed applicant is U.S. Imaging, Inc.. The 510(k) number is K881886.

When did MODIFIED X-RAY CONTROLS, MODEL ED125L AND ED150L receive FDA 510(k) clearance?

MODIFIED X-RAY CONTROLS, MODEL ED125L AND ED150L received FDA 510(k) clearance on 1988-08-04, under 510(k) number K881886.

Who is the listed applicant for MODIFIED X-RAY CONTROLS, MODEL ED125L AND ED150L?

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

What is the FDA product code for MODIFIED X-RAY CONTROLS, MODEL ED125L AND ED150L?

The FDA product code for MODIFIED X-RAY CONTROLS, MODEL ED125L AND ED150L is IZO.

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Other records listing U.S. Imaging, 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.

K900062U.S.I. MODEL 1012, REMOTE FLUOROSCOPIC CONTROLK890878PHOTOMULITPLIER TUBE INTERFACE P.C. BOARDK882358PULSED FLUOROSCOPIC CONTROL MODEL:PF-02

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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