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FDA 510(k)

ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM

K-Number: K010772 · 2001-08-23

ApplicantImaging Services, Inc.
Decision Date2001-08-23
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Services, Inc.. It received FDA 510(k) clearance on 2001-08-23 under 510(k) number K010772. 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 ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM?

ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM is a medical device that received FDA 510(k) clearance on 2001-08-23. The listed applicant is Imaging Services, Inc.. The 510(k) number is K010772.

When did ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM receive FDA 510(k) clearance?

ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM received FDA 510(k) clearance on 2001-08-23, under 510(k) number K010772.

Who is the listed applicant for ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM?

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

What is the FDA product code for ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM?

The FDA product code for ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM is JAA.

Other records listing Imaging Services, 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.

K955251OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM

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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