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FDA 510(k)

DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY)

K-Number: K982120 · 1998-09-10

ApplicantTrex Medical Corp.
Decision Date1998-09-10
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY) is the device name listed in this FDA 510(k) record. The listed applicant is Trex Medical Corp.. It received FDA 510(k) clearance on 1998-09-10 under 510(k) number K982120. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY)?

DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY) is a medical device that received FDA 510(k) clearance on 1998-09-10. The listed applicant is Trex Medical Corp.. The 510(k) number is K982120.

When did DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY) receive FDA 510(k) clearance?

DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY) received FDA 510(k) clearance on 1998-09-10, under 510(k) number K982120.

Who is the listed applicant for DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY)?

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

What is the FDA product code for DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY)?

The FDA product code for DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY) is LLZ.

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Other records listing Trex Medical 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.

K992229MXU-125 OR TMX-125K984091CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000K984092PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000K984414XRE COLLIMATOR WITH SPECTRAL FILTERK982427TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C

Related Devices (Code: LLZ)

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.

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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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