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FDA 510(k)

STAR 36

K-Number: K890066 · 1989-03-28

ApplicantTransworld X-Ray Corp.
Decision Date1989-03-28
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STAR 36 is the device name listed in this FDA 510(k) record. The listed applicant is Transworld X-Ray Corp.. It received FDA 510(k) clearance on 1989-03-28 under 510(k) number K890066. The device is classified under product code IZO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAR 36?

STAR 36 is a medical device that received FDA 510(k) clearance on 1989-03-28. The listed applicant is Transworld X-Ray Corp.. The 510(k) number is K890066.

When did STAR 36 receive FDA 510(k) clearance?

STAR 36 received FDA 510(k) clearance on 1989-03-28, under 510(k) number K890066.

Who is the listed applicant for STAR 36?

The FDA 510(k) record lists Transworld X-Ray Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STAR 36?

The FDA product code for STAR 36 is IZO.

Other records listing Transworld X-Ray Corp. 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.

K892657SENSIMATK873283MODEL C2-5000 OVERHEAD TUBE SUPPORTK872980MAM-CP X-RAY APPARATUSK872357TRANSWORLD 360V, MODEL A1-4040K841923DCX-100 CHEST UNIT-GL-5000MK827582MODIFIED X-RAY TABLE

View all 7 devices →

Related Devices (Code: IZO)

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.

K954666MPH50, MPH65, AND MPH80GE Medical SystemsK953582HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATORVarian Canada, Inc.K953831N 800 HFNucletron-Oldelft Corp.K952822SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150GShimadzu Corp.K952265MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATORControl-X, Inc.K950883POLYDOROS SX 65 AND 80Siemens Medical Solutions USA, Inc.

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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