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FDA 510(k)

COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE

K-Number: K980168 · 1998-04-02

ApplicantAnalogic Corp.
Decision Date1998-04-02
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Analogic Corp.. It received FDA 510(k) clearance on 1998-04-02 under 510(k) number K980168. 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 COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE?

COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE is a medical device that received FDA 510(k) clearance on 1998-04-02. The listed applicant is Analogic Corp.. The 510(k) number is K980168.

When did COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE receive FDA 510(k) clearance?

COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE received FDA 510(k) clearance on 1998-04-02, under 510(k) number K980168.

Who is the listed applicant for COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE?

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

What is the FDA product code for COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE?

The FDA product code for COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE is LLZ.

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Other records listing Analogic 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.

K071430SYNERAD OMNI, MODELS AN6255 AND AN6265K052447SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600K050919LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423PK043025SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250K041434C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORSK041376C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A

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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

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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