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FDA 510(k)

INSTANT IMAGER

K-Number: K833228 · 1983-10-28

ApplicantSchiff Photo Mechanics
Decision Date1983-10-28
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INSTANT IMAGER is the device name listed in this FDA 510(k) record. The listed applicant is Schiff Photo Mechanics. It received FDA 510(k) clearance on 1983-10-28 under 510(k) number K833228. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTANT IMAGER?

INSTANT IMAGER is a medical device that received FDA 510(k) clearance on 1983-10-28. The listed applicant is Schiff Photo Mechanics. The 510(k) number is K833228.

When did INSTANT IMAGER receive FDA 510(k) clearance?

INSTANT IMAGER received FDA 510(k) clearance on 1983-10-28, under 510(k) number K833228.

Who is the listed applicant for INSTANT IMAGER?

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

What is the FDA product code for INSTANT IMAGER?

The FDA product code for INSTANT IMAGER is JAK.

Related Clinical Trials

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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Other records listing Schiff Photo Mechanics 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.

K833233HOT SHOT

Related Devices (Code: JAK)

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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