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FDA 510(k)

SENSIMAT

K-Number: K892657 · 1989-06-23

ApplicantTransworld X-Ray Corp.
Decision Date1989-06-23
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SENSIMAT 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 1989-06-23 under 510(k) number K892657. 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 SENSIMAT?

SENSIMAT is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Transworld X-Ray Corp.. The 510(k) number is K892657.

When did SENSIMAT receive FDA 510(k) clearance?

SENSIMAT received FDA 510(k) clearance on 1989-06-23, under 510(k) number K892657.

Who is the listed applicant for SENSIMAT?

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 SENSIMAT?

The FDA product code for SENSIMAT is IZO.

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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.

K890066STAR 36K873283MODEL 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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