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FDA 510(k)

MST-1050-II X-RAY UNIT

K-Number: K853210 · 1985-10-10

ApplicantRadiological Engineering, Inc.
Decision Date1985-10-10
Product CodeKPA
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

MST-1050-II X-RAY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Radiological Engineering, Inc.. It received FDA 510(k) clearance on 1985-10-10 under 510(k) number K853210. The device is classified under product code KPA. It was reviewed by the PA advisory panel. Product code KPA falls under the category of Cardiovascular, which encompasses devices for cardiovascular diagnosis, monitoring, and intervention. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MST-1050-II X-RAY UNIT?

MST-1050-II X-RAY UNIT is a medical device that received FDA 510(k) clearance on 1985-10-10. The listed applicant is Radiological Engineering, Inc.. The 510(k) number is K853210.

When did MST-1050-II X-RAY UNIT receive FDA 510(k) clearance?

MST-1050-II X-RAY UNIT received FDA 510(k) clearance on 1985-10-10, under 510(k) number K853210.

Who is the listed applicant for MST-1050-II X-RAY UNIT?

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

What is the FDA product code for MST-1050-II X-RAY UNIT?

The FDA product code for MST-1050-II X-RAY UNIT is KPA. This falls under the Cardiovascular category.

Other records listing Radiological Engineering, 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.

K873702REI-38 RADIOGRAPHIC TABLEK854478REI-90/90 RADIOGRAPHIC TABLEK853175REI-90/15

Related Devices (Code: KPA)

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.

K933996PROFIBLOTTecan U.S., Ltd.K884258VERSABLOTAmerican Bionetics, Inc.K881592WESCOR MODEL 7300 AEROSPRAY GRAM STAINERWescor, Inc.K880745LX-100 SLIDE STAINERInnovative Medical Systems, Inc.K874887WESBLOT PROCESSORAmerican Bionetics, Inc.K874897SAKURA DRS-60 AUTOMATIC SLIDE STAINERSakura Finetek U.S.A., Inc.

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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