Cleared Special

K990734 - DPD-12PCC

K990734 is an FDA 510(k) clearance for DPD-12PCC, manufactured by Scanditronix Medical AB. The device is a Class 2 Radiology device with product code IYE cleared through the Special 510(k) pathway after a 84-day FDA review.

K990734 · Scanditronix Medical AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
84d
Days
Class 2
Risk

K990734 is an FDA 510(k) clearance for the DPD-12PCC. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Scanditronix Medical AB (Uppsala S-754 50, SE). The FDA issued a Cleared decision on May 28, 1999 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Scanditronix Medical AB devices

FDA 510(k) Submission Details - K990734

510(k) Number K990734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1999
Decision Date May 28, 1999
Days to Decision 84 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 107d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYE Accelerator, Linear, Medical

All 441
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K990734.
SHADOW TRAYS
K991107 · Mick Radio-Nuclear Instruments, Inc. · Jun 1999
AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER
K990997 · Aktina Medical Physics Corp. · Jun 1999
DOSE CALC, MODEL VS. 1.02
K990833 · Integrity Medical Software, Inc. · Jun 1999
ROCS ULTRASEED
K984241 · Radiation Oncology Computer Systems · May 1999
APOLLO 5, APOLLO 10
K990383 · Precitron A.B. · May 1999
FOCUS PILOT CONTOURING WORKSTATION
K981535 · Computerized Medical Systems, Inc. · Apr 1999