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FDA PMA

Unknown Device

PMA Number: P010053 · 2023-08-30

ApplicantSiemens Healthcare Diagnostics Products, Ltd.
Decision Date2023-08-30
PMA NumberP010053
Product Code
Advisory CommitteeMI

Device Summary

This device is the device name listed in this FDA PMA record. The listed applicant is Siemens Healthcare Diagnostics Products, Ltd.. It received FDA Premarket Approval (PMA) on 2023-08-30 under PMA number P010053. It was reviewed by the MI advisory panel. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is this device?

this device is a medical device that received FDA Premarket Approval (PMA) on 2023-08-30. The listed applicant is Siemens Healthcare Diagnostics Products, Ltd.. The PMA number is P010053.

When did this device receive FDA PMA approval?

this device received FDA PMA approval on 2023-08-30, under PMA number P010053.

Who is the listed applicant for this device?

The FDA PMA record lists Siemens Healthcare Diagnostics Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

Other records listing Siemens Healthcare Diagnostics Products, Ltd. 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.

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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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