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FDA 510(k)

HELIOS LASER IMAGER 1417

K-Number: K973028 · 1997-10-28

ApplicantSterling Diagnostic Imaging, Inc.
Decision Date1997-10-28
Product CodeLMC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HELIOS LASER IMAGER 1417 is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Diagnostic Imaging, Inc.. It received FDA 510(k) clearance on 1997-10-28 under 510(k) number K973028. The device is classified under product code LMC. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELIOS LASER IMAGER 1417?

HELIOS LASER IMAGER 1417 is a medical device that received FDA 510(k) clearance on 1997-10-28. The listed applicant is Sterling Diagnostic Imaging, Inc.. The 510(k) number is K973028.

When did HELIOS LASER IMAGER 1417 receive FDA 510(k) clearance?

HELIOS LASER IMAGER 1417 received FDA 510(k) clearance on 1997-10-28, under 510(k) number K973028.

Who is the listed applicant for HELIOS LASER IMAGER 1417?

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

What is the FDA product code for HELIOS LASER IMAGER 1417?

The FDA product code for HELIOS LASER IMAGER 1417 is LMC.

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Other records listing Sterling Diagnostic 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.

K980970IIRAD DIRECTRAY OPERATOR CONSOLEK980220IISYS PACS SYSTEMK974423ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAILK973206STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHYK972660RAVEN DRY PRINTERK964250LINX NETWORKING SYSTEM

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Related Devices (Code: LMC)

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.

K111566DRYVIEW CHROMA IMAGING SYSTEMCarestream Health, Inc.K092280CYPHER DICOM PRINT SOLUTIONVirtual Imaging, Inc.K090469CARESTREAM DRYVIEW 5850 LASER IMAGERCarestream Health, Inc.K083522SONY UP-DF750 DIGITAL FILM IMAGERSony Electronics, Inc.K081637LASER IMAGER DRYPRO MODEL 873Konica Minolta Medical & Graphic, Inc.K072680DRYSTAR AXYS, MODEL EYZ4EAgfa Healthcare Corporation

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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