D2 Spectrum Gamma Camera/Crystal V Computer System

FDA 510(k) K904599 · Digital Design, Inc.

Substantially Equivalent

510(k) numberK904599

Submission

Device name
D2 Spectrum Gamma Camera/Crystal V Computer System
Applicant
Digital Design, Inc.
Norcross, GA, US
Received
October 10, 1990
Decision date
April 23, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JWM – System, Tomographic, Nuclear
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1310
Specialty
Radiology

Other 510(k)s with product code JWM

510(k)DeviceApplicantDecision
K914350Icon Computer SystemJWM · Traditional Siemens Gammasonics, Inc.11/22/1991SE
K903315IconJWM · Traditional Siemens Gammasonics, Inc.01/09/1991SE
K901545GCA-9300 Nuclear Tomography SystemJWM · Traditional Toshiba America Medical Systems, In.C06/26/1990SE
K874473Adac Model Arc-St, PC Style Data Processing SystemJWM · Traditional Adac Laboratories07/18/1988SE
K873075Adac Model ARC-5000, Gamma CameraJWM · Traditional Adac Laboratories10/30/1987SE
K851685Digital Gamma Camera Gca 601 EJWM · Traditional Toshiba Medical Systems06/14/1985SE
K850885Starcam Data Acquisition & Processing Sys H3300CJWM · Traditional General Electric Co.06/06/1985SE
K851687Jumbo Digital Gammacamera GCA-90BJWM · Traditional Toshiba Medical Systems06/05/1985SE
K851686Digital Gamma Camera Gca 501SJWM · Traditional Toshiba Medical Systems06/05/1985SE
K841905Dot-A, Dot-Ar Pxp-E, Pxp-ErJWM · Traditional Siemens Gammasonics, Inc.08/09/1984SE

Questions and answers

When was D2 Spectrum Gamma Camera/Crystal V Computer System cleared by the FDA?

D2 Spectrum Gamma Camera/Crystal V Computer System (K904599) received a 510(k) decision of Substantially Equivalent on April 23, 1991, 195 days after the submission was received.

What is the product code of K904599?

The FDA product code is JWM – System, Tomographic, Nuclear, a Class II (moderate risk) device regulated under 21 CFR 892.1310.