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FDA 510(k)

DIGI-X

K-Number: K834483 · 1984-03-05

ApplicantRadiation Measurements, Inc.
Decision Date1984-03-05
Product CodeLHO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGI-X is the device name listed in this FDA 510(k) record. The listed applicant is Radiation Measurements, Inc.. It received FDA 510(k) clearance on 1984-03-05 under 510(k) number K834483. The device is classified under product code LHO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGI-X?

DIGI-X is a medical device that received FDA 510(k) clearance on 1984-03-05. The listed applicant is Radiation Measurements, Inc.. The 510(k) number is K834483.

When did DIGI-X receive FDA 510(k) clearance?

DIGI-X received FDA 510(k) clearance on 1984-03-05, under 510(k) number K834483.

Who is the listed applicant for DIGI-X?

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

What is the FDA product code for DIGI-X?

The FDA product code for DIGI-X is LHO.

Other records listing Radiation Measurements, 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.

K893216RMI ULTRASOUND DOPPLER PHANTOM SYSTEMK885223RMI SHORT DISTANCE ALIGNMENT DEVICEK873956ULTIMETERK873836MAMMOGRAPHIC KVP METER MODEL 232K854976RMI RESPIRATORY GATING SYSTEM MODEL 301K834607ELECTRONIC KVP CASSETTE

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Related Devices (Code: LHO)

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.

K042733STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEMStandard Imaging, Inc.K873956ULTIMETERRadiation Measurements, Inc.K860260MULTI PURPOSE MODEL 76-903Victoreen, Inc.K853754MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901Victoreen, Inc.K860100MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902Victoreen, Inc.K844620BDS-3 BEAM DATA SCANNERVarian Assoc., 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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