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Simplicit90Y

FDA UDIFDA 510(k)

Class II (US FDA UDI)

510(k) K182016

by Mirada Medical, Ltd.

Identity

Trade Name
Simplicit90Y FDA UDI
Generic Name
Radiology picture archiving and communication system workstation FDA UDI
Model / Reference
2.6 FDA UDI

Identifiers

Primary DI / UDI-DI
B334SY2P60 FDA UDI
510(k) Number
K182016 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Radiology picture archiving and communication system workstation FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiology picture archiving and communication system workstation

Simplicit90Y by Mirada Medical, Ltd. — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Similar devices

Also classified as Radiology picture archiving and communication system workstation.

Cleared under the same submission

K182016 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mirada Medical, Ltd.

Sources (2)

  • FDA UDI 763dd481-3bb6-4746-9492-fe8f04df2ce0 57 fields · synced Jun 18, 2026
  • FDA 510(k) K182016 1 fields · synced Jun 4, 2026