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D-SPECT Refurbished

FDA UDI

Class II (US FDA UDI)

by Spectrum Dynamics Medical Inc.

Identity

Trade Name
D-SPECT Refurbished FDA UDI
Generic Name
SPECT system, annular detector array FDA UDI
Device Name
Single Photon Emission Computed Tomography system FDA UDI
Model / Reference
D-SPECT 004 FDA UDI
Description
Single Photon Emission Computed Tomography system FDA UDI

Identifiers

Catalog Number
8010013-01 FDA UDI
Primary DI / UDI-DI
07290108670158 FDA UDI
510(k) Number
K161740 FDA UDI
FDA Product Code
KPS FDA UDI
GMDN Term
SPECT system, annular detector array FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1200 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: SPECT system, annular detector array

D-SPECT Refurbished by Spectrum Dynamics Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as SPECT system, annular detector array.

Cleared under the same submission

K161740 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spectrum Dynamics Medical Inc.

Sources (1)

  • FDA UDI 2198db02-7b95-4fe6-8ab4-72c7ffd1356c 35 fields · synced May 30, 2026