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FDA 510(k)

SII 360 APR

K-Number: K950041 · 1995-03-21

ApplicantScott Imaging Intl., Inc.
Decision Date1995-03-21
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SII 360 APR is the device name listed in this FDA 510(k) record. The listed applicant is Scott Imaging Intl., Inc.. It received FDA 510(k) clearance on 1995-03-21 under 510(k) number K950041. 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 SII 360 APR?

SII 360 APR is a medical device that received FDA 510(k) clearance on 1995-03-21. The listed applicant is Scott Imaging Intl., Inc.. The 510(k) number is K950041.

When did SII 360 APR receive FDA 510(k) clearance?

SII 360 APR received FDA 510(k) clearance on 1995-03-21, under 510(k) number K950041.

Who is the listed applicant for SII 360 APR?

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

What is the FDA product code for SII 360 APR?

The FDA product code for SII 360 APR is IZO.

Other records listing Scott Imaging Intl., 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.

K946260NTBS-1417, 1436, TBS-1417K950040SII 525 APRK946261MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000K946262EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLESK945708SII 360 MSK945709SII 525 MS

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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