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FDA 510(k)

STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER

K-Number: K001825 · 2000-08-02

ApplicantStandard Imaging, Inc.
Decision Date2000-08-02
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER is the device name listed in this FDA 510(k) record. The listed applicant is Standard Imaging, Inc.. It received FDA 510(k) clearance on 2000-08-02 under 510(k) number K001825. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER?

STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER is a medical device that received FDA 510(k) clearance on 2000-08-02. The listed applicant is Standard Imaging, Inc.. The 510(k) number is K001825.

When did STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER receive FDA 510(k) clearance?

STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER received FDA 510(k) clearance on 2000-08-02, under 510(k) number K001825.

Who is the listed applicant for STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER?

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

What is the FDA product code for STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER?

The FDA product code for STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER is JAQ.

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Other records listing Standard 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.

K103193DOSEVIEW 3DK082773STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331K060532HDR 1000 PLUS WELL CHAMBER, MODEL 90008K042733STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEMK040688STANDARD IMAGING E.IMRT CALCULATORK013548STANDARD IMAGING IVB 1000 WELL CHAMBER

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Related Devices (Code: JAQ)

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.

K262383LumenCare AzureNucletron B.V.K252717MAASTRO Rectal Applicator SetVarian Medical SystemsK251037Rectal ApplicatorNucletron B.V.K252884Guided Aarhus Applicator SetVarian Medical SystemsK250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc.K250289Intracavitary/Interstitial SystemVarian Medical Systems

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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