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FDA 510(k)

MEDRAD IMAGE MANAGEMENT SYSTEM (MIMS)

K-Number: K883604 · 1988-11-15

ApplicantMedrad, Inc.
Decision Date1988-11-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDRAD IMAGE MANAGEMENT SYSTEM (MIMS) is the device name listed in this FDA 510(k) record. The listed applicant is Medrad, Inc.. It received FDA 510(k) clearance on 1988-11-15 under 510(k) number K883604. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDRAD IMAGE MANAGEMENT SYSTEM (MIMS)?

MEDRAD IMAGE MANAGEMENT SYSTEM (MIMS) is a medical device that received FDA 510(k) clearance on 1988-11-15. The listed applicant is Medrad, Inc.. The 510(k) number is K883604.

When did MEDRAD IMAGE MANAGEMENT SYSTEM (MIMS) receive FDA 510(k) clearance?

MEDRAD IMAGE MANAGEMENT SYSTEM (MIMS) received FDA 510(k) clearance on 1988-11-15, under 510(k) number K883604.

Who is the listed applicant for MEDRAD IMAGE MANAGEMENT SYSTEM (MIMS)?

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

What is the FDA product code for MEDRAD IMAGE MANAGEMENT SYSTEM (MIMS)?

The FDA product code for MEDRAD IMAGE MANAGEMENT SYSTEM (MIMS) is LLZ.

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Other records listing Medrad, 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.

K130381ANGIOJET ULTRA POWER PULSE KITK130637JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEMK122916JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEMK113363ANGIOJET SOLENT DISTA THROMBECTOMY SETK113133MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGEK113428ANGIOJET ULTRA DVX THROMBECTOMY SET

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Related Devices (Code: LLZ)

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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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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