# K000908: Skylight Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Apr 5, 2000 after 15 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020343: Surgassist System; Wireless Remote Control (Component); Wired Remote Control (2002), 13 descendants of its own
- K053510: IR Wireless Foot Switch (2006), 12 descendants of its own
- K083161: Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100) (2009), 9 descendants of its own
- K100638: Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214 (2010), 8 descendants of its own
- K152777: Bovie Disposable Bipolar Ablator (2016), 3 descendants of its own

## Recalls of this device
- Feb 23, 2012 · Not classified · Z-1219-2012: Incorrect Standardized Uptake Value ("SUV") values are displayed in two instances: 1. After loading PET data (with a Slope value different than 1) into the Quick Review (QR) application from a remote 
- Dec 8, 2011 · Not classified · Z-0607-2012: During preventative maintenance, a crack was discovered in the lower portion of the old style, non-common arm for the detector assembly, which could result in the detector dropping in an uncontrolled 
- Sep 27, 2011 · Not classified · Z-0254-2012: A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
- Sep 27, 2011 · Not classified · Z-0251-2012: A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
- Sep 27, 2011 · Not classified · Z-0252-2012: A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
- Sep 27, 2011 · Not classified · Z-0253-2012: A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
- Sep 27, 2011 · Not classified · Z-0247-2012: A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
- Sep 27, 2011 · Not classified · Z-0249-2012: A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
- Sep 27, 2011 · Not classified · Z-0248-2012: A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
- Sep 27, 2011 · Not classified · Z-0250-2012: A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
- Dec 28, 2010 · Not classified · Z-1552-2011: Philips Healthcare Nuclear Medicine determined that the detector arm assembly could be compromised.
- Dec 28, 2010 · Not classified · Z-1551-2011: Philips Healthcare Nuclear Medicine determined that the detector arm assembly could be compromised.
- Oct 15, 2010 · Not classified · Z-0398-2011: Detector arm assembly may slide to hardware limit, potentially causing impact.

Source page: https://510kreport.com/device/K000908
Methodology: https://510kreport.com/methodology