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FDA 510(k)

DIGITAL SUBTRACTION RADIOGRAPHY SYSTEM

K-Number: K801948 · 1980-09-26

ApplicantTechnicare Corp.
Decision Date1980-09-26
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL SUBTRACTION RADIOGRAPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Technicare Corp.. It received FDA 510(k) clearance on 1980-09-26 under 510(k) number K801948. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL SUBTRACTION RADIOGRAPHY SYSTEM?

DIGITAL SUBTRACTION RADIOGRAPHY SYSTEM is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is Technicare Corp.. The 510(k) number is K801948.

When did DIGITAL SUBTRACTION RADIOGRAPHY SYSTEM receive FDA 510(k) clearance?

DIGITAL SUBTRACTION RADIOGRAPHY SYSTEM received FDA 510(k) clearance on 1980-09-26, under 510(k) number K801948.

Who is the listed applicant for DIGITAL SUBTRACTION RADIOGRAPHY SYSTEM?

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

What is the FDA product code for DIGITAL SUBTRACTION RADIOGRAPHY SYSTEM?

The FDA product code for DIGITAL SUBTRACTION RADIOGRAPHY SYSTEM is JAA.

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Other records listing Technicare 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.

K854340TECHNICARE 720 HPS CT SCANNERK852089SATURN NUCLEAR MEDICINE COMPUTER SYSTEMK844293AUTO DII MULTI FREQUENCYK844247ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMSK843716NUCLEAR 700 MEDICINE MECHANICAL POSIT-K842777AUTOFOCUS DUAL ELEMENT PROBE

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Related Devices (Code: JAA)

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.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

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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